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Orientation Booklet for Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rioko Kimiko Sakata, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01440491
First received: September 13, 2011
Last updated: September 23, 2011
Last verified: January 2008
  Purpose

The aim of this study was to evaluate the effect of exercises performed under monitoring of the physiotherapist and self performed at home by reading the booklet of exercise orientation for patients with nonspecific low back pain.

A prospective and randomized trial was performed in 44 patients. G1 patients received a physiotherapist orientation, and G2 patients received the booklet of exercise to self perform the exercises. Pain intensity by Visual Analogue Scale (VAS), and quality of life by SF-36 were measured before.

Results: Pain intensity was lower in G1 than in G2 after 6 and 12 weeks. Quality of life was better in G1.

The exercises under orientations of the physiotherapist promoted best effect than self performed exercises .


Condition Intervention
Low Back Pain
Other: Physiotherapy exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Orientation Through a Booklet of Exercise in Patients With Low Back Pain

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Pain intensity was measured by VAS, and quality of life by SF-36


Enrollment: 44
Study Start Date: May 2008
Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
physiotherapy orientated

G1 patients were orientated by the physiotherapist during the performance of physiotherapy exercises, using the booklet

G2 received the booklet to self perform the physiotherapy exercises

Other: Physiotherapy exercise
once a day, during 15 minutes, for 12 weeks
Other Name: Exercise therapy

Detailed Description:

After approval by the Ethics Committee and signing a consent form, a prospective, randomized trial was performed in 44 patients with chronic nonspecific low back pain (lasting longer than 3 months), pain intensity greater than 3 by visual analogue scale and age > 18 years. Patients with renal and gastrointestinal disease, simultaneously submitted to another type of physical therapy, cognitive impairment, and pregnant women were excluded.

All patients received an exercise booklet which consisted of stretching and strengthening of muscles. G1 patients were orientated by the physiotherapist during the performance of exercises once a week, using the booklet, and the patients in G2 (n=22) received the booklet to self perform the exercises without orientation of the physiotherapist. Everyone should perform the exercises once a day at home.

Pain intensity by VAS, and quality of life by SF-36 were measured before the start of treatment (T0), after 6 (T6) and 12 (T12) weeks. Side effects were recorded. Acetaminophen (up to 4 g / day) could be used as necessary.

The sample size was provided by SAS 8.0, SPSS 15.0 program. To detect difference in pain intensity of 3 between the groups by VAS, with 95% of power (estimated SD= 2.0), when the alpha level is set at 0.05, the sample should be of 16. The program used for statistical analysis was SAS 8.0, SPSS 15.0. The tests used were Student's T to compare age of patients, chi-square to compare gender and analgesic complementation, and Mann Whitney test for pain intensity and quality of life.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic nonspecific low back pain (lasting longer than 3 months),
  • pain intensity greater than 3 by visual analogue scale and age > 18 years

Exclusion Criteria:

  • Patients with renal and gastrointestinal disease,
  • simultaneously submitted to another type of physical therapy,
  • cognitive impairment, and
  • pregnant women were excluded
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440491

Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Director: Rioko K Sakata, MD, PhD Universidade Federal de São Paulo
  More Information

No publications provided

Responsible Party: Rioko Kimiko Sakata, Pain Clinic Director, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01440491     History of Changes
Other Study ID Numbers: CEP1871/07
Study First Received: September 13, 2011
Last Updated: September 23, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
low back pain
exercise
booklet

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014