Condition category
Musculoskeletal Diseases
Date applied
05/12/2005
Date assigned
05/12/2005
Last edited
06/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof B.W. Koes

ORCID ID

Contact details

Erasmus Medical Center
Department of General Practice
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 4087620
b.koes@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Results of a systematic review showed that lumbar supports are not effective in the primary prevention of Low Back Pain (LBP), but there were positive indications for the secondary preventive use of lumbar supports in the reduction of low back pain. In this randomised controlled trial (RCT) we study the secondary preventive efficacy of these lumbar supports.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Low back pain (LBP)

Intervention

A lumbar support was provided to the intervention group in addition to usual care (primary and secondary care for the management of LBP, available as usual).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Number of days low back pain per month
2. Number of days sick leave per year (calendar days)
3. Cost effectiveness

Secondary outcome measures

1. Severity of experienced low back pain (11 point NRS)
2. Functional status (Quebec Back Pain Disability Scale)
3. Compliance

Overall trial start date

01/05/2003

Overall trial end date

30/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Reporting LBP at the start of the study, or reporting two or more episodes of LBP in the 12 months prior to the start of the study
2. Performing medical care and/or domestic tasks as a home care worker

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

360

Participant exclusion criteria

1. Suffering from specific LBP e.g. rheumatoid arthritis or vertebral fractions
2. Pregnant at the start of the study
3. Receiving medical treatment for high blood pressure

Recruitment start date

01/05/2003

Recruitment end date

30/12/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3000 DR
Netherlands

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands) - Department of General Practice

Sponsor details

P.O. Box 1738
Rotterdam
3000 DR
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12361993
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18025444
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20823783

Publication citations

  1. Results

    Jellema P, Bierma-Zeinstra SM, Van Poppel MN, Bernsen RM, Koes BW, Feasibility of lumbar supports for home care workers with low back pain., Occup Med (Lond), 2002, 52, 6, 317-323.

  2. Results

    Roelofs PD, Bierma-Zeinstra SM, van Poppel MN, Jellema P, Willemsen SP, van Tulder MW, van Mechelen W, Koes BW, Lumbar supports to prevent recurrent low back pain among home care workers: a randomized trial., Ann. Intern. Med., 2007, 147, 10, 685-692.

  3. Results

    Roelofs PD, Bierma-Zeinstra SM, van Poppel MN, van Mechelen W, Koes BW, van Tulder MW, Cost-effectiveness of lumbar supports for home care workers with recurrent low back pain: an economic evaluation alongside a randomized-controlled trial., Spine, 2010, 35, 26, E1619-26, doi: 10.1097/BRS.0b013e3181cf7244.

Additional files

Editorial Notes