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

August 13, 2010 updated by: Tehran University of Medical Sciences

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Study Chair: Fereydoun Davatchi, MD, Rheumatology Research Center, Medical Sciences/University of Tehran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 5, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

August 16, 2010

Last Update Submitted That Met QC Criteria

August 13, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 85-04-41-4972

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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