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Improvement in Pain,Function and HRQoL ( Health Related Quality of Life) in Subacute Low Back Pain: A Controlled Clinical Trial of Exercise vs NSAIDs (Nonsteroidal Antiinflammatory) (DLSEA)

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ClinicalTrials.gov Identifier: NCT01374269
Recruitment Status : Completed
First Posted : June 15, 2011
Results First Posted : April 29, 2014
Last Update Posted : April 29, 2014
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by (Responsible Party):
Fabio Alonso Salinas Duran, Grupo Rehabilitacion en Salud

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Back Pain Lower Back
Interventions Other: Exercise program
Drug: NSAID (Nonsteroidal anti-inflammatory drugs)
Enrollment 90

Recruitment Details Patients (18 and 60 years) with SLBP (subacute low back pain) (lasting 4-12 weeks) with or without radiculopathy who were assigned to the social security system and living in the metropolitan area were included.
Pre-assignment Details A specific cause for the pain (infection, tumor, ankylosing spondylitis, inflammatory conditions or cauda equine syndrome), the presence of red flags, scoliosis >15 °, depression or mental illness, history of gastrointestinal bleeding, renal failure, intake of anticoagulants or antiplatelet drugs and NSAID allergy were excluded.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Period Title: Overall Study
Started 46 44
Completed 40 39
Not Completed 6 5
Reason Not Completed
Withdrawal by Subject             4             0
Lost to Follow-up             1             3
closed research             1             2
Arm/Group Title Excercise NSAID Total
Hide Arm/Group Description

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Total of all reporting groups
Overall Number of Baseline Participants 46 44 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 44 participants 90 participants
38.5  (12.3) 40.3  (13.2) 39.4  (12.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
Female
37
  80.4%
33
  75.0%
70
  77.8%
Male
9
  19.6%
11
  25.0%
20
  22.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Colombia Number Analyzed 46 participants 44 participants 90 participants
46 44 90
1.Primary Outcome
Title Visual Analogue Scale of Pain
Hide Description In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at the beginning.
Time Frame At the beginning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
47.3  (19.8) 45.2  (22.6)
2.Primary Outcome
Title Visual Analogue Scale of Pain
Hide Description In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 4 weeks.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
28.8  (20.5) 34.9  (25.0)
3.Primary Outcome
Title Visual Analogue Scale of Pain
Hide Description In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 12 weeks.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
21.0  (24.4) 20.6  (17.2)
4.Primary Outcome
Title Visual Analogue Scale of Pain
Hide Description The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.8  (21.8) 17.5  (18.1)
5.Secondary Outcome
Title Oswestry Disability Index
Hide Description Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Time Frame At the beginning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
28.9  (13.1) 29.4  (15.1)
6.Secondary Outcome
Title Oswestry Disability Index
Hide Description Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
21.9  (12.6) 26.6  (18.5)
7.Secondary Outcome
Title Oswestry Disability Index
Hide Description Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.6  (13.2) 19.4  (13.7)
8.Secondary Outcome
Title Oswestry Disability Index
Hide Description Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.8  (12.2) 17.2  (14.0)
9.Secondary Outcome
Title Roland-Morris Questionnaire
Hide Description Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.
Time Frame At the beginning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.9  (4.4) 7.7  (5.2)
10.Secondary Outcome
Title Roland-Morris Questionnaire
Hide Description Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.2  (3.2) 4.6  (4.0)
11.Secondary Outcome
Title Roland-Morris Questionnaire
Hide Description Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.6  (2.5) 3.2  (2.4)
12.Secondary Outcome
Title Roland-Morris Questionnaire
Hide Description Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.3  (3.0) 2.5  (2.6)
13.Secondary Outcome
Title Quality of Life, Change in Health
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.
Time Frame At the beginning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
52.6  (13.5) 54.5  (16.9)
14.Secondary Outcome
Title Quality of Life, Change in Health
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
60.4  (18.1) 61.3  (21.7)
15.Secondary Outcome
Title Quality of Life, Change in Health
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
73.3  (21.0) 67.0  (20.5)
16.Secondary Outcome
Title Quality of Life, Change in Health
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
78.0  (18.0) 70.7  (18.2)
17.Secondary Outcome
Title Quality of Life, Bodily Pain
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.
Time Frame At the beginning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
39.5  (13.4) 39.2  (13.3)
18.Secondary Outcome
Title Quality of Life, Bodily Pain
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
57.8  (18.7) 54.0  (19.5)
19.Secondary Outcome
Title Quality of Life, Bodily Pain
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
67.6  (21.7) 58.7  (16.1)
20.Secondary Outcome
Title Quality of Life, Bodily Pain
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
74.1  (22.4) 68  (20.6)
21.Secondary Outcome
Title Quality of Life, Emotional Performance.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.
Time Frame At the beginning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
67.2  (36.6) 63.4  (38.4)
22.Secondary Outcome
Title Quality of Life, Emotional Performance.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
82.5  (32.8) 84.7  (29.2)
23.Secondary Outcome
Title Quality of Life, Emotional Performance.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
91.2  (24.5) 82.4  (33.8)
24.Secondary Outcome
Title Quality of Life, Emotional Performance.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
94.1  (21.2) 93.9  (20.1)
25.Secondary Outcome
Title Quality of Life, Physical Performance.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance
Time Frame At the beginning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
30.5  (34.0) 36.0  (40.9)
26.Secondary Outcome
Title Quality of Life, Physical Performance.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
58.1  (39.4) 55.1  (42.9)
27.Secondary Outcome
Title Quality of Life, Physical Performance.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
77.3  (33) 72.5  (40.7)
28.Secondary Outcome
Title Quality of Life, Physical Performance.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
84.3  (33.3) 85.2  (30.7)
29.Secondary Outcome
Title Quality of Life, Physical Function.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.
Time Frame At the beginning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
64.6  (21.6) 66.5  (17.8)
30.Secondary Outcome
Title Quality of Life, Physical Function.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
75.8  (17.5) 70.3  (23.3)
31.Secondary Outcome
Title Quality of Life, Physical Function.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
81.6  (16) 77.2  (82.6)
32.Secondary Outcome
Title Quality of Life, Physical Function.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
84.1  (16.9) 82.6  (16.0)
33.Secondary Outcome
Title Quality of Life, Social Function.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.
Time Frame At the beginning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
71.3  (23.5) 65.9  (24.2)
34.Secondary Outcome
Title Quality of Life, Social Function.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
80.7  (19.9) 74.8  (24.4)
35.Secondary Outcome
Title Quality of Life, Social Function.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
87.3  (17.2) 80.4  (18.3)
36.Secondary Outcome
Title Quality of Life, Social Function.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
88.6  (17.4) 86  (15.1)
37.Secondary Outcome
Title Quality of Life, General Health Perceptions.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.
Time Frame At the beginning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
64.3  (19.1) 64.7  (18.3)
38.Secondary Outcome
Title Quality of Life, General Health Perceptions.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
66.3  (18.5) 67.1  (20.01)
39.Secondary Outcome
Title Quality of Life, General Health Perceptions.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
72.0  (19.9) 69.2  (16.9)
40.Secondary Outcome
Title Quality of Life, General Health Perceptions.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
73.4  (17.6) 69.3  (15.8)
41.Secondary Outcome
Title Quality of Life, Mental Health.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.
Time Frame At the beginning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
66.4  (20.6) 67.0  (19.8)
42.Secondary Outcome
Title Quality of Life, Mental Health.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
71.4  (18.9) 74.6  (20.0)
43.Secondary Outcome
Title Quality of Life, Mental Health.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
76.4  (16.4) 75.6  (16.5)
44.Secondary Outcome
Title Quality of Life, Mental Health.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
78.5  (16.1) 76.9  (16.3)
45.Secondary Outcome
Title Quality of Life, Vitality.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.
Time Frame At the beginning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
55.5  (17.9) 55.3  (17.6)
46.Secondary Outcome
Title Quality of Life, Vitality.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
61.3  (18.5) 64.0  (20.2)
47.Secondary Outcome
Title Quality of Life, Vitality.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
67.5  (17.7) 66.6  (15.6)
48.Secondary Outcome
Title Quality of Life, Vitality.
Hide Description Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
70.3  (17.0) 62.8  (14.5)
49.Secondary Outcome
Title PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
Hide Description Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.9  (4.0) 3.4  (3.3)
50.Secondary Outcome
Title PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
Hide Description Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).
Time Frame At the beginning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.7  (4.3) 5.1  (3.0)
51.Secondary Outcome
Title PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
Hide Description Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.0  (3.1) 3.2  (2.7)
52.Secondary Outcome
Title PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
Hide Description Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.3  (2.5) 3.1  (3.0)
53.Secondary Outcome
Title Relapses of Lumbar Pain
Hide Description The percentage of patients with relapsed of low back pain was measured.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Measure Type: Number
Unit of Measure: percentage of participants
7.1 25
54.Secondary Outcome
Title Relapses of Lumbar Pain
Hide Description The percentage of patients with relapsed of low back pain was measured.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Measure Type: Number
Unit of Measure: percentage of participants
5.0 20.5
55.Secondary Outcome
Title Treatments Associated With Low Back Pain at 6 Months
Hide Description we are showing in this result, the number of patients who had to receive any additional treatment in either group. The measure is the number of participants who received additional treatment throughout the duration of the study.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Measure Type: Number
Unit of Measure: participants
3 14
56.Secondary Outcome
Title Missing Workdays
Hide Description This result shows the average of the number of missed work days.
Time Frame 6 weeks before starting
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: Days
1.0  (2.9) 1.7  (6.2)
57.Secondary Outcome
Title Missing Workdays
Hide Description This result shows the average of the number of missed work days.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: Days
0.0  (0.0) 0.3  (1.6)
58.Secondary Outcome
Title Missing Workdays
Hide Description This result shows the average of the number of missed work days.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: Days
0.0  (0.4) 0.1  (0.6)
59.Secondary Outcome
Title Missing Workdays
Hide Description This result shows the average of the number of missed work days.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: Days
0.2  (0.7) 0.2  (0.9)
60.Secondary Outcome
Title Medical Consultations.
Hide Description This result shows, the total number of participants received additional medical consultations.
Time Frame 4 weeks
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[Not Specified]
Arm/Group Title Excercise NSAID
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One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 46 44
Measure Type: Number
Unit of Measure: participants
4 6
61.Secondary Outcome
Title Medical Consultations.
Hide Description This result shows, the total number of participants received additional medical consultations.
Time Frame 12 weeks
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We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 42 40
Measure Type: Number
Unit of Measure: participants
1 6
62.Secondary Outcome
Title Medical Consultations.
Hide Description This result shows, the total number of participants received additional medical consultations.
Time Frame 24 weeks
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We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
Arm/Group Title Excercise NSAID
Hide Arm/Group Description:

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

Overall Number of Participants Analyzed 40 39
Measure Type: Number
Unit of Measure: participants
4 4
Time Frame Adverse effects were recorded that occurred during the 6-month study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Excercise NSAID
Hide Arm/Group Description

One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered

Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.

All-Cause Mortality
Excercise NSAID
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Excercise NSAID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/46 (0.00%)      0/44 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Excercise NSAID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/46 (0.00%)      14/44 (31.82%)    
Gastrointestinal disorders     
Epigastric pain * 1  0/46 (0.00%)  0 7/44 (15.91%)  7
Diarrhea * 1  0/46 (0.00%)  0 5/44 (11.36%)  5
Immune system disorders     
Rash * 1  0/46 (0.00%)  0 2/44 (4.55%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Not serious
The study population was associated with the university’s health service. Female subjects predominated. The 6-month follow-up prevents conclusions about the improvement duration. No subgroup classification was performed. No control group was planned.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Fabio Salinas Duran
Organization: Grupo Rehabilitacion en Salud
Phone: 5742196475
Responsible Party: Fabio Alonso Salinas Duran, Grupo Rehabilitacion en Salud
ClinicalTrials.gov Identifier: NCT01374269     History of Changes
Other Study ID Numbers: DLSejervsaine
DLSEjercicioyAINES ( Registry Identifier: GrupoRS )
First Submitted: June 14, 2011
First Posted: June 15, 2011
Results First Submitted: September 20, 2013
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014