Back School Efficacy on Low Back Pain and Quality of Life of Workers. COPCORD STUDY (Stage II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00596076
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : August 16, 2010
Information provided by:
Tehran University of Medical Sciences

Brief Summary:
The study is an intervention, Phase II COPCORD study. (COPCORD= Community Oriented Program to Control Rheumatic Diseases). The purpose of this study is to find if Back School training has any benefit on low back pain of the workers in a pharmaceutical factory in Tehran suburbs.

Condition or disease Intervention/treatment Phase
Low Back Pain Behavioral: Back School Phase 3

Detailed Description:
A back school will be held on at the Modava Pharmaceutical Factory, in Tehran suburbs. We estimate that this prospective study will include almost one third of the 70 workers in the factory. The study provides objective data and subjective information from patients. The clinical benefits of back school on low back pain and quality of life will be reported at the beginning and the end of intervention and after a period of 6 months follow up.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Back School on Low Back Pain and Quality of Life of Workers of a Pharmaceutics Company in Tehran Suburb. COPCORD Study (Stage II)
Study Start Date : February 2008
Actual Primary Completion Date : March 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Workers with low back pain
Behavioral: Back School

All the workers undergo a clinical examination for low back pain, by two trained practitioner. Those workers who are diagnosed for mechanical low back pain during the last six months fulfill a self report Quality of Life Questionnaire (SF36). The objective level of low back pain will obtain by a visual analogue scale. Then a back school training course will be held in 6 sessions, in 6 consecutive weeks. Two previously trained physiotherapists are responsible for the training course. Each series will have 10 participants. They will learn vertebral column anatomy and its function at the first session. The proper posture and exercises to reduce or inhibit low back pain are taught in the next 4 sessions. The 6th session is arranged for answering questions and checking how exercises are performed.

A visual analogue scale and quality of life assessment will be held at the end of the last session and the end of the sixth month.

Primary Outcome Measures :
  1. 1- Comparison of quality of life in patients with low back pain before and after Back school training. 2- Comparison of low back pain based on a visual analogue scale before and after back school training. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • History of mechanical low back pain in the last six months

Exclusion Criteria:

  • History of inflammatory spinal diseases
  • Severe scoliosis
  • History of spinal surgery
  • History of spinal malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00596076

Iran, Islamic Republic of
Rheumatology Research Center
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Study Chair: Fereydoun Davatchi, MD Rheumatology Research Center, Medical Sciences/University of Tehran

Responsible Party: Dr Fereidoon Davatchi, Rheumatology Research Center Identifier: NCT00596076     History of Changes
Other Study ID Numbers: 85-04-41-4972
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: August 16, 2010
Last Verified: August 2010

Keywords provided by Tehran University of Medical Sciences:
Low back pain

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