Global Postural Reeducation in Chronic Low Back Pain (GPR)
|ClinicalTrials.gov Identifier: NCT01557049|
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : March 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Back Pain Mechanical Low Back Pain||Other: Control Group Other: Global Reeducation Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Global Postural Reeducation in Chronic Low Back Pain: an Randomized Controlled Trial|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
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.
- Change from baseline in pain [ Time Frame: 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.
- Change from baseline in function [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557049
|São Paulo Federal University UNIFESP|
|São Paulo, Brazil, 04023-900|
|Principal Investigator:||Priscila Maria Lawand, Author||Federal University of São Paulo|