Global Postural Reeducation in Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Back Pain; Mechanical Low Back Pain
• Interventions: Other: Global Reeducation Group; Other: Control Group

• Registration Number: NCT01557049
• Lead Sponsor: Federal University of São Paulo

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).

Study Timeline

• Study Start: 2008-06
• Status Verified: 2010-04
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-15
• Last Update Submitted: 2012-03-15
• Study First Posted: 2012-03-19
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postural Reeducation Group	Global Reeducation Group	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.
Control Group	Control Group	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in pain	baseline and two follow-up examinations - after 3 and 6 months from baseline	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in function	It was collected at baseline and two follow-up examinations after 3 and 6 months from baseline.	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.

Trial Locations

Locations (1)

São Paulo Federal University UNIFESP; 🇧🇷 São Paulo, Brazil