Lumbar supports for home care workers with low back pain, an efficacy study

ISRCTN	ISRCTN73707379
DOI	https://doi.org/10.1186/ISRCTN73707379
Protocol serial number	N/A
Sponsor	Erasmus Medical Center (The Netherlands) - Department of General Practice
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof B.W. Koes
Scientific

Erasmus Medical Center
Department of General Practice
P.O. Box 1738
Rotterdam
3000 DR
Netherlands

Phone	+31 (0)10 4087620
Email	b.koes@erasmusmc.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Number of days low back pain per month 2. Number of days sick leave per year (calendar days) 3. Cost effectiveness
Key secondary outcome measure(s)	1. Severity of experienced low back pain (11 point NRS) 2. Functional status (Quebec Back Pain Disability Scale) 3. Compliance
Completion date	30/12/2004

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	360
Key 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
Key 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
Date of first enrolment	01/05/2003
Date of final enrolment	30/12/2004

Erasmus Medical Center

Rotterdam
3000 DR
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/09/2002	Yes	No
Results article	results	20/11/2007	Yes	No
Results article	results	15/12/2010	Yes	No