ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00155662
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Behavioral: work-hardening program Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : August 2002
Actual Primary Completion Date : December 2004
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain




Primary Outcome Measures :
  1. functional capacity evaluation, Oswestry disability index

Secondary Outcome Measures :
  1. low back pain, work hardening


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155662


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: J Y Tsauo, PhD Grad School of PT, College of Medicine, NTU

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00155662     History of Changes
Other Study ID Numbers: 9100002906
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

Keywords provided by National Taiwan University Hospital:
work hardening
chronic low back pain over 3 months

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms