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NCT00600197 Clinical Trial

Biopsychosocial Education and Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00600197
Other study ID # 86-03-41-5465
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 13, 2008
Last updated November 17, 2009
Start date July 2008
Est. completion date September 2012

Study information
Verified date November 2009
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 170
Est. completion date September 2012
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• back school
A kind of educational program for low back pain

Locations
Country Name City State
Iran, Islamic Republic of Tehran University of Medical Sciences Tehran

Sponsors (1)
Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability before intervention Yes
Secondary SF-36,Roland Morris Disability Questionnaire, Quebec back pain disability 3-6-12-18-24-30-36 month after intervention Yes
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