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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Back School
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rheumatology Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Workers with low back pain

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
January 5, 2008
Last Updated
August 13, 2010
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00596076
Brief Title
Back School Efficacy on Low Back Pain and Quality of Life of Workers. COPCORD STUDY (Stage II)
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 Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Workers with low back pain
Intervention Type
Behavioral
Intervention Name(s)
Back School
Intervention Description
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fereydoun Davatchi, MD
Organizational Affiliation
Rheumatology Research Center, Medical Sciences/University of Tehran
Official's Role
Study Chair
Facility Information:
Facility Name
Rheumatology Research Center
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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