NCT00596076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3 low-back-pain

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_3 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

August 16, 2010

Status Verified

August 1, 2010

Enrollment Period

29 days

First QC Date

January 5, 2008

Last Update Submit

August 13, 2010

Conditions

Keywords

Low back pain

Outcome Measures

Primary Outcomes (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.

    6 months

Study Arms (1)

1

EXPERIMENTAL

Workers with low back pain

Behavioral: Back School

Interventions

Back SchoolBEHAVIORAL

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.

1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology Research Center

Tehran, Tehran Province, 14114, Iran

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fereydoun Davatchi, MD

    Rheumatology Research Center, Medical Sciences/University of Tehran

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2008

First Posted

January 16, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2008

Study Completion

September 1, 2008

Last Updated

August 16, 2010

Record last verified: 2010-08

Locations