Global Postural Reeducation in Chronic Low Back Pain

Back Pain Clinical Trial

— GPR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557049
• Other study ID #: 1324/07
• Status: Completed
• Phase: N/A
• First received: March 13, 2012
• Last updated: March 15, 2012
• Start date: June 2008
• Est. completion date: February 2012

Study information

• Verified date: April 2010
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Mechanical Low Back Pain

Intervention

Other:
• Control Group
No physical intervention was given, patients were treated only with medication if necessary.
• Global Reeducation Group
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.

Locations

Country	Name	City	State
Brazil	São Paulo Federal University UNIFESP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No

External Links

•   Postural Global Reeducation Society
•   São Paulo Federal University