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

Tracking Information

First Received Date ^ICMJE

January 5, 2008

Last Updated Date

February 7, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00596076 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

Behavioral: Back School

Study Arms / Comparison Groups

Experimental: Workers with low back pain

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT ID ^ICMJE

NCT00596076

Responsible Party

Dr Fereidoon Davatchi, Rheumatology Research Center

Study ID Numbers ^ICMJE

85-04-41-4972

Study Sponsor ^ICMJE

Tehran University of Medical Sciences

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Fereydoun Davatchi, MD

Rheumatology Research Center, Medical Sciences/University of Tehran

Information Provided By

Tehran University of Medical Sciences

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP