- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00316342
Workplace Based Rehabilitation for Low Back Disorders
Study Overview
Detailed Description
BACKGROUND Low back pain remains a common major source of morbidity and disability. Few studies consider the effectiveness of interventions for low back pain while simultaneously considering personal, health, and job characteristics.
METHODS This is a randomized clinical trial in which 433 active employees with low back disorders were randomly assigned to one of two study groups: 1) back support plus education on back health; or 2) education on back health only. Demographic, health, medical, and job factors were recorded. Outcomes were evaluated over a twelve month period and included self-reported measures of back pain, back pain disability level, physical health, mental health, back pain recurrence and administrative measures.
RESULTS Significant improvements in physical health, neurogenic symptoms, back pain disability, and low back pain were observed over time in both study groups. However, there was no significant difference between the study groups with respect to these outcome measures. The adjusted hazard ratio of recurrence rate was suggestive of an incremental protective effect due to back supports over education alone (adjusted hazard ratio [AHR]=0.711, 95% CI 0.50, 1.04, p=.085). There was also a marginal effect of back supports and education on decreasing low back pain over time (AHR=0.0015, p=0.091).
CONCLUSIONS Back supports may have some value in promoting recovery from low back pain, but this effect is only observed in individuals who are actively employed in jobs with medium risk of low back disorders.
Study Type
Enrollment
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
work-related low back disorder, 18-64 years of age,active hourly worker, enrollment into study within eight weeks of diagnosis, signed informed consent
Exclusion Criteria:
no other concurrent work-related condition not pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Low back pain
|
Back pain disability
|
Neurogenic symptoms
|
Physical health
|
Mental health
|
Low back pain repeated episodes
|
Lost work time
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Denise M Oleske, PhD, Rush University Medical Center
Publications and helpful links
General Publications
- Oleske DM, Lavender SA, Andersson GB, Morrissey MJ, Zold-Kilbourn P, Allen C, Taylor E. Risk factors for recurrent episodes of work-related low back disorders in an industrial population. Spine (Phila Pa 1976). 2006 Apr 1;31(7):789-98. doi: 10.1097/01.brs.0000207017.30490.28.
- Oleske DM, Neelakantan J, Andersson GB, Hinrichs BG, Lavender SA, Morrissey MJ, Zold-Kilbourn P, Taylor E. Factors affecting recovery from work-related, low back disorders in autoworkers. Arch Phys Med Rehabil. 2004 Aug;85(8):1362-4. doi: 10.1016/j.apmr.2003.11.021.
- Oleske D, Lavender S, Andersson G, Hahn J, Zold-Kilbourn P, Allen-Toole C, Laskowski J. Job exposures as correlates of recovery in population-based rehabilitation intervention for work-related low back disorders. Ann Epidemiol. 2000 Oct 1;10(7):481. doi: 10.1016/s1047-2797(00)00165-4.
- Oleske DM, Andersson GB, Lavender SA, Hahn JJ. Association between recovery outcomes for work-related low back disorders and personal, family, and work factors. Spine (Phila Pa 1976). 2000 May 15;25(10):1259-65. doi: 10.1097/00007632-200005150-00010.
- Lavender SA, Oleske DM, Nicholson L, Andersson GB, Hahn J. Comparison of five methods used to determine low back disorder risk in a manufacturing environment. Spine (Phila Pa 1976). 1999 Jul 15;24(14):1441-8. doi: 10.1097/00007632-199907150-00009.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 95050341
- #97-1-AP
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University of ExtremaduraCompletedChronic Low Back Pain | Postural Low Back PainSpain
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Université du Québec à Trois-RivièresCompletedChronic Low Back Pain | Mechanical Low Back PainCanada
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Michigan State UniversityUniversity of MichiganCompleted
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