Workplace Based Rehabilitation for Low Back Disorders
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Back supports
Sponsored by
About this trial
This is an interventional other trial for Low Back Pain focused on measuring Low back pain, Industrial workers, Recurrent back pain, Back supports, Back health education, Rehabilitation
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
Sites / Locations
Outcomes
Primary Outcome Measures
Low back pain
Back pain disability
Neurogenic symptoms
Physical health
Mental health
Low back pain repeated episodes
Lost work time
Secondary Outcome Measures
Full Information
NCT ID
NCT00316342
First Posted
April 18, 2006
Last Updated
July 9, 2023
Sponsor
Rush University Medical Center
Collaborators
The UAW-GM National Joint Committee on Health & Safety
1. Study Identification
Unique Protocol Identification Number
NCT00316342
Brief Title
Workplace Based Rehabilitation for Low Back Disorders
Official Title
Workplace Based Rehabilitation for Low Back Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rush University Medical Center
Collaborators
The UAW-GM National Joint Committee on Health & Safety
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Industrial workers, Recurrent back pain, Back supports, Back health education, Rehabilitation
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
433 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Back supports
Primary Outcome Measure Information:
Title
Low back pain
Title
Back pain disability
Title
Neurogenic symptoms
Title
Physical health
Title
Mental health
Title
Low back pain repeated episodes
Title
Lost work time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise M Oleske, PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
16582853
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.
Results Reference
background
PubMed Identifier
15295767
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.
Results Reference
background
PubMed Identifier
11018430
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.
Results Reference
background
PubMed Identifier
10806503
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.
Results Reference
background
PubMed Identifier
10423789
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.
Results Reference
background
Learn more about this trial
Workplace Based Rehabilitation for Low Back Disorders
We'll reach out to this number within 24 hrs