Biopsychosocial Education and Chronic Low Back Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Tehran University of Medical Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00600197
First received: January 13, 2008
Last updated: November 17, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention
Chronic Low Back Pain
Behavioral: back school

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness of Biopsychosocial Education on Quality of Life and Disability of Individuals Suffering From Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability [ Time Frame: before intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • SF-36,Roland Morris Disability Questionnaire, Quebec back pain disability [ Time Frame: 3-6-12-18-24-30-36 month after intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 170
Study Start Date: July 2008
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Back school
a kind of educational program for low back pain
Behavioral: 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
Behavioral: back school
a kind of educational program for low back pain

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600197

Locations
Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: Ahmad Re Jamshidi, MD Tehran University of Medical Sciences
  More Information

No publications provided by Tehran University of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sedigheh Sadat Tavafian, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00600197     History of Changes
Other Study ID Numbers: 86-03-41-5465
Study First Received: January 13, 2008
Last Updated: November 17, 2009
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014