Global Postural Reeducation in Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of a Global Postural Reeducation (GPR) program in subjects with chronic low back pain.

Detailed Description
-----------------
Approximately 80-85% of individuals will experience low back pain during their lifetime. It is one of the major concerns of current health care. There is evidence for the effectiveness of exercise therapy in patients with chronic low back pain. GPR is a physical therapy method developed in France by Philippe Emmanuel Souchard. Although this method is largely used as form of treatment in most countries, few studies showed its clinical effectiveness in chronic low back pain. This is the first randomized controlled trial, with assessor blind that evaluate the GPR effects in chronic low back pain. All outcome measurements are reliability, validated and sensitivity for statistical changes using the Visual Analogic Scale- VAS (0-10cm), Roland Morris Questionary, SF36 (Quality Life Questionary) and Beck Scale (Depression Symptoms).

Official Title
-----------------
Global Postural Reeducation in Chronic Low Back Pain: an Randomized Controlled Trial

Conditions
-----------------
Back Pain, Mechanical Low Back Pain

Intervention / Treatment
-----------------
* Other: Control Group
* Other: Global Reeducation Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between 18-65 years age, low back pain (more than 12 weeks) without legs irradiation, pain between 3-8 cm on a visual Analogue scale (0-10cm). Exclusion Criteria: fibromyalgia, pregnancy, osteoporosis severe, disc herniation, patients who had undergone spinal surgical or physiotherapeutic interventions within 3 months prior to baseline assessment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postural Reeducation Group<br>The participants, after obtaining a written informed consent, were randomized for one of the two groups: In the Global Postural Reeducation group (GPR), they were submitted 1 time per week, during 12 weeks, at GPR sessions. The duration of sessions was 60 minutes each, with the same physical Therapist of the study. After the intervention, subjects returned to assessment 3 months after, with the blinded assessor. All the 6 postures from GPR were used during the study. All outcomes measurements, in both groups, were validated for Portuguese language and applicable at baseline, 3 months and 6 months after baseline. | Other: Global Reeducation Group<br>* They were treated with medication if necessary and performed GPR session once a week, during 12 weeks. All the 6 postures from GPR were used during the study.<br>|
| No Intervention: Control Group<br>In the control group, no physical intervention was given during the study. After the study, 6 months after, all participants from control group received the same treatment given in GPR group, according to the Unifesp Ethics Committee orientations. All participants, of both groups, have a doctor from the study, if necessary. | Other: Control Group<br>* No physical intervention was given, patients were treated only with medication if necessary.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain | The primary outcome of this study was the measurement of pain assessed with 0-10cm Visual Analogue Scale (VAS). They were collected at baseline and two follow-up examinations after 3 and 6 months from baseline. | baseline and two follow-up examinations - after 3 and 6 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in function | The secondary outcome included function measured by Roland Morris Questionnaire. It was collected at baseline and two follow-up examinations after 3 and 6 months from baseline. | It was collected at baseline and two follow-up examinations after 3 and 6 months from baseline. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic low back pain, Postural global reeducation, randomized, physical rehabilitation