NCT00316342

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
433

participants targeted

Target at P50-P75 for phase_3 low-back-pain

Timeline
Completed

Started Jan 1997

Longer than P75 for phase_3 low-back-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

First QC Date

April 18, 2006

Last Update Submit

July 9, 2023

Conditions

Low Back Pain

Keywords

Low back painIndustrial workersRecurrent back painBack supportsBack health educationRehabilitation

Outcome Measures

Primary Outcomes (7)

  • Low back pain

  • Back pain disability

  • Neurogenic symptoms

  • Physical health

  • Mental health

  • Low back pain repeated episodes

  • Lost work time

Interventions

Back supportsDEVICE

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • work-related low back disorder, 18-64 years of age,active hourly worker, enrollment into study within eight weeks of diagnosis, signed informed consent

You may not qualify if:

  • no other concurrent work-related condition not pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 16582853BACKGROUND

  • 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.

    PMID: 15295767BACKGROUND

  • 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.

    PMID: 11018430BACKGROUND

  • 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.

    PMID: 10806503BACKGROUND

  • 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.

    PMID: 10423789BACKGROUND

MeSH Terms

Conditions

Low Back PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Denise M Oleske, PhD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 20, 2006

Study Start

January 1, 1997

Study Completion

November 1, 2004

Last Updated

July 11, 2023

Record last verified: 2023-07