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

Sponsored by:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00596076

Purpose

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	Intervention	Phase
Low Back Pain	Behavioral: Back School	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

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

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Study Completion Date:	September 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

Arms

Assigned Interventions

1: Experimental

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596076

Locations

Iran, Islamic Republic of
Rheumatology Research Center
Tehran, Iran, Islamic Republic of, 14114

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Study Chair:

Fereydoun Davatchi, MD

Rheumatology Research Center, Medical Sciences/University of Tehran

More Information

No publications provided

Responsible Party:	Rheumatology Research Center ( Dr Fereidoon Davatchi )
Study ID Numbers:	85-04-41-4972
Study First Received:	January 5, 2008
Last Updated:	February 7, 2009
ClinicalTrials.gov Identifier:	NCT00596076 History of Changes
Health Authority:	Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:

Low back pain

Study placed in the following topic categories:

Signs and Symptoms
Quality of Life
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

ClinicalTrials.gov processed this record on July 02, 2009