Global Postural Reeducation in Chronic Low Back Pain (GPR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Priscila Maria Mendonca de Almeida Lawand, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01557049
First received: March 13, 2012
Last updated: March 15, 2012
Last verified: April 2010
  Purpose

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


Condition Intervention
Back Pain
Mechanical Low Back Pain
Other: Control Group
Other: Global Reeducation Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Global Postural Reeducation in Chronic Low Back Pain: an Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Change from baseline in pain [ Time Frame: baseline and two follow-up examinations - after 3 and 6 months from baseline ] [ Designated as safety issue: No ]
    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:
  • Change from baseline in function [ Time Frame: It was collected at baseline and two follow-up examinations after 3 and 6 months from baseline. ] [ Designated as safety issue: No ]
    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.


Enrollment: 61
Study Start Date: June 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Postural 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.
Other: 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.
No Intervention: 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.
Other: Control Group
No physical intervention was given, patients were treated only with medication if necessary.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557049

Locations
Brazil
São Paulo Federal University UNIFESP
São Paulo, Brazil, 04023-900
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Priscila Maria Lawand, Author Federal University of São Paulo
  More Information

Additional Information:
No publications provided

Responsible Party: Priscila Maria Mendonca de Almeida Lawand, physical therapeutic, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01557049     History of Changes
Other Study ID Numbers: 1324/07
Study First Received: March 13, 2012
Last Updated: March 15, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
chronic low back pain
Postural global reeducation
randomized
physical rehabilitation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014