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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)

This study has been completed.
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by (Responsible Party):
Fabio Alonso Salinas Duran, Grupo Rehabilitacion en Salud
ClinicalTrials.gov Identifier:
NCT01374269
First received: June 14, 2011
Last updated: March 18, 2014
Last verified: March 2014
Results First Received: September 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Back Pain Lower Back
Interventions: Other: Exercise program
Drug: NSAID (Nonsteroidal anti-inflammatory drugs)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Excercise

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.

NSAID

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.


Participant Flow:   Overall Study
    Excercise     NSAID  
STARTED     46     44  
COMPLETED     40     39  
NOT COMPLETED     6     5  
Withdrawal by Subject                 4                 0  
Lost to Follow-up                 1                 3  
closed research                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Excercise

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.

NSAID

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 Total of all reporting groups

Baseline Measures
    Excercise     NSAID     Total  
Number of Participants  
[units: participants]
  46     44     90  
Age  
[units: years]
Mean ± Standard Deviation
  38.5  ± 12.3     40.3  ± 13.2     39.4  ± 12.74  
Gender  
[units: participants]
     
Female     37     33     70  
Male     9     11     20  
Region of Enrollment  
[units: participants]
     
Colombia     46     44     90  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Analogue Scale of Pain   [ Time Frame: At the beginning ]

2.  Primary:   Visual Analogue Scale of Pain   [ Time Frame: 4 weeks ]

3.  Primary:   Visual Analogue Scale of Pain   [ Time Frame: 12 weeks ]

4.  Primary:   Visual Analogue Scale of Pain   [ Time Frame: 24 weeks ]

5.  Secondary:   Oswestry Disability Index   [ Time Frame: At the beginning ]

6.  Secondary:   Oswestry Disability Index   [ Time Frame: 4 weeks ]

7.  Secondary:   Oswestry Disability Index   [ Time Frame: 12 weeks ]

8.  Secondary:   Oswestry Disability Index   [ Time Frame: 24 weeks ]

9.  Secondary:   Roland-Morris Questionnaire   [ Time Frame: At the beginning ]

10.  Secondary:   Roland-Morris Questionnaire   [ Time Frame: 4 weeks ]

11.  Secondary:   Roland-Morris Questionnaire   [ Time Frame: 12 weeks ]

12.  Secondary:   Roland-Morris Questionnaire   [ Time Frame: 24 weeks ]

13.  Secondary:   Quality of Life, Change in Health   [ Time Frame: At the beginning ]

14.  Secondary:   Quality of Life, Change in Health   [ Time Frame: 4 weeks ]

15.  Secondary:   Quality of Life, Change in Health   [ Time Frame: 12 weeks ]

16.  Secondary:   Quality of Life, Change in Health   [ Time Frame: 24 weeks ]

17.  Secondary:   Quality of Life, Bodily Pain   [ Time Frame: At the beginning ]

18.  Secondary:   Quality of Life, Bodily Pain   [ Time Frame: 4 weeks ]

19.  Secondary:   Quality of Life, Bodily Pain   [ Time Frame: 12 weeks ]

20.  Secondary:   Quality of Life, Bodily Pain   [ Time Frame: 24 weeks ]

21.  Secondary:   Quality of Life, Emotional Performance.   [ Time Frame: At the beginning ]

22.  Secondary:   Quality of Life, Emotional Performance.   [ Time Frame: 4 weeks ]

23.  Secondary:   Quality of Life, Emotional Performance.   [ Time Frame: 12 weeks ]

24.  Secondary:   Quality of Life, Emotional Performance.   [ Time Frame: 24 weeks ]

25.  Secondary:   Quality of Life, Physical Performance.   [ Time Frame: At the beginning ]

26.  Secondary:   Quality of Life, Physical Performance.   [ Time Frame: 4 weeks ]

27.  Secondary:   Quality of Life, Physical Performance.   [ Time Frame: 12 weeks ]

28.  Secondary:   Quality of Life, Physical Performance.   [ Time Frame: 24 weeks ]

29.  Secondary:   Quality of Life, Physical Function.   [ Time Frame: At the beginning ]

30.  Secondary:   Quality of Life, Physical Function.   [ Time Frame: 4 weeks ]

31.  Secondary:   Quality of Life, Physical Function.   [ Time Frame: 12 weeks ]

32.  Secondary:   Quality of Life, Physical Function.   [ Time Frame: 24 weeks ]

33.  Secondary:   Quality of Life, Social Function.   [ Time Frame: At the beginning ]

34.  Secondary:   Quality of Life, Social Function.   [ Time Frame: 4 weeks ]

35.  Secondary:   Quality of Life, Social Function.   [ Time Frame: 12 weeks ]

36.  Secondary:   Quality of Life, Social Function.   [ Time Frame: 24 weeks ]

37.  Secondary:   Quality of Life, General Health Perceptions.   [ Time Frame: At the beginning ]

38.  Secondary:   Quality of Life, General Health Perceptions.   [ Time Frame: 4 weeks ]

39.  Secondary:   Quality of Life, General Health Perceptions.   [ Time Frame: 12 weeks ]

40.  Secondary:   Quality of Life, General Health Perceptions.   [ Time Frame: 24 weeks ]

41.  Secondary:   Quality of Life, Mental Health.   [ Time Frame: At the beginning ]

42.  Secondary:   Quality of Life, Mental Health.   [ Time Frame: 4 weeks ]

43.  Secondary:   Quality of Life, Mental Health.   [ Time Frame: 12 weeks ]

44.  Secondary:   Quality of Life, Mental Health.   [ Time Frame: 24 weeks ]

45.  Secondary:   Quality of Life, Vitality.   [ Time Frame: At the beginning ]

46.  Secondary:   Quality of Life, Vitality.   [ Time Frame: 4 weeks ]

47.  Secondary:   Quality of Life, Vitality.   [ Time Frame: 12 weeks ]

48.  Secondary:   Quality of Life, Vitality.   [ Time Frame: 24 weeks ]

49.  Secondary:   PHQ-9 Patient Health Questionnaire (PHQ-9) Depression   [ Time Frame: 4 weeks ]

50.  Secondary:   PHQ-9 Patient Health Questionnaire (PHQ-9) Depression   [ Time Frame: At the beginning ]

51.  Secondary:   PHQ-9 Patient Health Questionnaire (PHQ-9) Depression   [ Time Frame: 12 weeks ]

52.  Secondary:   PHQ-9 Patient Health Questionnaire (PHQ-9) Depression   [ Time Frame: 24 weeks ]

53.  Secondary:   Relapses of Lumbar Pain   [ Time Frame: 12 weeks ]

54.  Secondary:   Relapses of Lumbar Pain   [ Time Frame: 24 weeks ]

55.  Secondary:   Treatments Associated With Low Back Pain at 6 Months   [ Time Frame: 6 months ]

56.  Secondary:   Missing Workdays   [ Time Frame: 6 weeks before starting ]

57.  Secondary:   Missing Workdays   [ Time Frame: 4 weeks ]

58.  Secondary:   Missing Workdays   [ Time Frame: 12 weeks ]

59.  Secondary:   Missing Workdays   [ Time Frame: 24 weeks ]

60.  Secondary:   Medical Consultations.   [ Time Frame: 4 weeks ]

61.  Secondary:   Medical Consultations.   [ Time Frame: 12 weeks ]

62.  Secondary:   Medical Consultations.   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: fabios@une.net.co


No publications provided


Responsible Party: Fabio Alonso Salinas Duran, Grupo Rehabilitacion en Salud
ClinicalTrials.gov Identifier: NCT01374269     History of Changes
Other Study ID Numbers: DLSejervsaine, DLSEjercicioyAINES
Study First Received: June 14, 2011
Results First Received: September 20, 2013
Last Updated: March 18, 2014
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos