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Biopsychosocial Education and Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
back school
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tehran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Back school

back school

Arm Description

a kind of educational program for low back pain

Outcomes

Primary Outcome Measures

SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability

Secondary Outcome Measures

SF-36,Roland Morris Disability Questionnaire, Quebec back pain disability

Full Information

First Posted
January 13, 2008
Last Updated
November 17, 2009
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00600197
Brief Title
Biopsychosocial Education and Chronic Low Back Pain
Official Title
The Effectiveness of Biopsychosocial Education on Quality of Life and Disability of Individuals Suffering From Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Back school
Arm Type
Experimental
Arm Description
a kind of educational program for low back pain
Arm Title
back school
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
back school
Intervention Description
A kind of educational program for low back pain
Primary Outcome Measure Information:
Title
SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability
Time Frame
before intervention
Secondary Outcome Measure Information:
Title
SF-36,Roland Morris Disability Questionnaire, Quebec back pain disability
Time Frame
3-6-12-18-24-30-36 month after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad Re Jamshidi, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Tehran University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24576271
Citation
Tavafian SS, Jamshidi AR, Mohammad K. Treatment of low back pain: randomized clinical trial comparing a multidisciplinary group-based rehabilitation program with oral drug treatment up to 12 months. Int J Rheum Dis. 2014 Feb;17(2):159-64. doi: 10.1111/1756-185X.12116. Epub 2013 Jun 21.
Results Reference
derived

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Biopsychosocial Education and Chronic Low Back Pain

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