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Orientation Booklet for Low Back Pain

NCT ID: NCT01440491

Last Updated: 2011-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Physiotherapy exercise

Intervention Type OTHER

once a day, during 15 minutes, for 12 weeks

Interventions

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Physiotherapy exercise

once a day, during 15 minutes, for 12 weeks

Intervention Type OTHER

Other Intervention Names

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Exercise therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Rioko Kimiko Sakata

Pain Clinic Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rioko K Sakata, MD, PhD

Role: STUDY_DIRECTOR

Universidade Federal de São Paulo

Other Identifiers

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CEP1871/07

Identifier Type: -

Identifier Source: org_study_id