Biopsychosocial Education and Chronic Low Back Pain

November 17, 2009 updated by: Tehran University of Medical Sciences

The Effectiveness of Biopsychosocial Education on Quality of Life and Disability of Individuals Suffering From Chronic Low Back Pain

The purpose of this study is to examine whether the biopsychosocial educational program could improve patients' health-related quality of life at 3-6-12-18-24-30 and 36 - month follow up.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Little information exists on biopsychosocial educational program as a multidimensional and interdisciplinary program in which Quality Of Life is as an outcome measure. Thus this educational Program designed in this study is a an outpatient program that used a health education approach to empower participants through a process of assessment, education and skill building in three dimensions of physical,mental and social that leading to improved quality of life. The purpose of this study was to examine to what extent this educational Program could improve low back pain patients' HRQOL.

Study Type

Interventional

Enrollment (Anticipated)

170

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

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Low Back Pain lasting more than 12 weeks with or without pain radiating to the legs.
  • age 18-70 years.

Exclusion Criteria:

  • Osteoporosis
  • Newly operation on the back up to 2 years before the beginning of the study
  • Fresh vertebral fracture
  • Malignancy
  • Infection in the back
  • spondylolisthesis
  • Problem in understanding Farsi Language

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Back school
a kind of educational program for low back pain
Behavioral: back school
A kind of educational program for low back pain
Experimental: back school
Behavioral: back school
A kind of educational program for low back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability
Time Frame: before intervention
before intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
SF-36,Roland Morris Disability Questionnaire, Quebec back pain disability
Time Frame: 3-6-12-18-24-30-36 month after intervention
3-6-12-18-24-30-36 month after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Study Chair: Ahmad Re Jamshidi, MD, Tehran University of Medical Sciences

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.

General Publications

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

July 1, 2008

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

January 13, 2008

First Submitted That Met QC Criteria

January 13, 2008

First Posted (Estimate)

January 24, 2008

Study Record Updates

Last Update Posted (Estimate)

November 18, 2009

Last Update Submitted That Met QC Criteria

November 17, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 86-03-41-5465

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.

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