- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01557049
Global Postural Reeducation in Chronic Low Back Pain (GPR)
March 15, 2012 updated by: Priscila Maria Mendonca de Almeida Lawand, Federal University of São Paulo
Global Postural Reeducation in Chronic Low Back Pain: an Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness of a Global Postural Reeducation (GPR) program in subjects with chronic low back pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo, Brazil, 04023-900
- São Paulo Federal University UNIFESP
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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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.
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No physical intervention was given, patients were treated only with medication if necessary.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline in pain
Time Frame: baseline and two follow-up examinations - after 3 and 6 months from baseline
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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.
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baseline and two follow-up examinations - after 3 and 6 months from baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline in function
Time Frame: It was collected at baseline and two follow-up examinations after 3 and 6 months from baseline.
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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.
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It was collected at baseline and two follow-up examinations after 3 and 6 months from baseline.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Priscila Maria Lawand, Author, Federal University of São Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
March 13, 2012
First Submitted That Met QC Criteria
March 15, 2012
First Posted (Estimate)
March 19, 2012
Study Record Updates
Last Update Posted (Estimate)
March 19, 2012
Last Update Submitted That Met QC Criteria
March 15, 2012
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1324/07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.