Clinical trial NCT01440491: Orientation Booklet for Low Back Pain
Official title: Effect of Orientation Through a Booklet of Exercise in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
exercise
booklet
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-09-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 .

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 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

Primary outcomes:
measure: Pain
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal de São Paulo
name: Rioko K Sakata, MD, PhD
role: STUDY_DIRECTOR
References: