Global Postural Reeducation in Chronic Low Back Pain (GPR)
This study has been completed.
Sponsor:
Federal University of São Paulo
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
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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
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 May 23, 2013