The Effect of a Work-hardening Program for Return-to-work for Workers With Low Back Pain

December 5, 2012 updated by: National Taiwan University Hospital

Occupational injury results in family economic crisis and national productivity loss; it is really becoming an important issue in Taiwanese society. Low back pain is the most frequent injury affecting workers. In addition to the prevention of injury, having a work-hardening program and getting the injured workers returned to work are also challenges for medical personnel. The purposes of this study are:

  1. to develop a guideline to assess the low back pain workers' impairment and working capacity;
  2. to formulate a feasible work-hardening program for the low back pain workers; and
  3. to execute the program, evaluate the training effect and then follow up the rate of return to work of the low back pain workers.

In the first year, a guideline for assessment of low back impairment and working capacity will be developed. It may consist of the demographic data, the working status, the physical need in work, trunk muscle isokinetic strength, Oswestry low back disability questionnaire, functional capacity evaluation and quality of life questionnaire. The whole assessment package will be empirically applied in low back pain workers and the validity and reliability will be tested. A work-hardening program for low back pain workers will be established in the first year through meetings with experts and literature review. The work-hardening program will consist of training of trunk muscle strength, flexibility, and general fitness. A sling-exercise training model will be applied in the program. In the second year, low back pain workers in outpatient departments will be recruited with their own agreement and grouped randomly into either the work-hardening group or the control group. The expected number of subjects is 30 in each group. According to the result of impairment assessment and work capacity, the workers in the work-hardening group will start the individualized work-hardening program for 3 months. After the program, the workers will be assessed again to evaluate the training's effect, and the investigators will follow the rate of return to work among them 3 and 6 months after the program. The workers in the control group will be followed for 6 and 9 months after enrollment to collect the rate of return to work in this group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Occupational injury results in family economic crisis and national productivity loss; it is really becoming an important issue in our society. Low back pain is the most frequent injury affecting workers. In addition to the prevention of injury, having a work-hardening program and getting the injured workers returned to work are also challenges for medical personnel. The purposes of this study are:

  1. to develop a guideline to assess the low back pain workers' impairment and working capacity;
  2. to formulate a feasible work-hardening program for the low back pain workers; and
  3. to execute the program, evaluate the training effect and then follow up the rate of return to work of the low back pain workers.

In the first year, a guideline for assessment of low back impairment and working capacity will be developed. It may consist of the demographic data, the working status, the physical need in work, trunk muscle isokinetic strength, Oswestry low back disability questionnaire, functional capacity evaluation and quality of life questionnaire. The whole assessment package will be empirically applied in low back pain workers and the validity and reliability will be tested. A work-hardening program for low back pain workers will be established in the first year through meetings and literature review. The work-hardening program will consist of training of trunk muscle strength, flexibility, and general fitness. A sling-exercise-training model will be applied in the program. In the second year, low back pain workers in outpatient departments will be recruited with their own agreement and grouped randomly into either the work-hardening group or the control group. The expected number of subjects is 30 in each group. According to the result of impairment assessment and work capacity, the workers in the work-hardening group will start the individualized work-hardening program for 3 months. After the program, the workers will be assessed again to evaluate the training's effect, and the investigators will follow the rate of return to work among them 3 and 6 months after the program. The workers in the control group will be followed for 6 and 9 months after enrollment to collect the rate of return to work in this group.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 to 65 years
  • Have a job
  • Low back pain

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

  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
functional capacity evaluation, Oswestry disability index

Secondary Outcome Measures

Outcome Measure
low back pain, work hardening

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

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

August 1, 2002

Primary Completion (ACTUAL)

December 1, 2004

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (ESTIMATE)

September 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9100002906

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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