Orientation Booklet for Low Back Pain

Low Back Pain Clinical Trial

Official title:

Effect of Orientation Through a Booklet of Exercise in Patients With Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440491
• Other study ID #: CEP1871/07
• Status: Completed
• Phase: N/A
• First received: September 13, 2011
• Last updated: September 23, 2011
• Start date: May 2008
• Est. completion date: September 2010

Study information

• Verified date: January 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Physiotherapy exercise
once a day, during 15 minutes, for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain intensity was measured by VAS, and quality of life by SF-36	12 weeks	No