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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01557049
Other study ID # 1324/07
Secondary ID
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


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
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