Clinical trial NCT00316342: Workplace Based Rehabilitation for Low Back Disorders
Official title: Workplace Based Rehabilitation for Low Back Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Low back pain
Industrial workers
Recurrent back pain
Back supports
Back health education
Rehabilitation
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: The UAW-GM National Joint Committee on Health & Safety
First posted: 2006-04-20
Enrollment: 433
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine the effect of back supports plus education upon recovery from a work-related low back disorder. The study tests the hypothesis: the use of back supports plus health education is not different from health education alone in promoting recovery from a work-related low back disorder in consideration of personal, health, and job factors. Significant improvements in physical health, neurogenic symptoms, back pain disability, and low back pain were observed over the twelve months of study follow-up. No statistically significant difference between the study groups was found with respect to these measures.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Low back pain
measure: Back pain disability
measure: Neurogenic symptoms
measure: Physical health
measure: Mental health
measure: Low back pain repeated episodes
measure: Lost work time
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rush University Medical Center
name: Denise M Oleske, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.