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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
Rush University Medical Center
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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

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    Workplace Based Rehabilitation for Low Back Disorders

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