Condition category
Musculoskeletal Diseases
Date applied
02/11/2005
Date assigned
02/11/2005
Last edited
29/10/2008
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

Dr W. IJzelenberg

ORCID ID

Contact details

Erasmus Medical Center Rotterdam
Department of Public Health
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 4087718
w.ijzelenberg@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR395

Study information

Scientific title

Acronym

Study hypothesis

What is the cost-effectiveness of a back training programme consisting of a combination of three parts: counselling and training to prevent back complaints, analysis and ergonomic adaptation of the work station, and quick intervention in the origin of (absenteeism due to) back complaints?

Ethics approval

Received from a local medical ethics committee

Study design

Economic evaluation alongside a cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Low back pain (LBP)

Intervention

The physical therapy programme consists of an integrated approach of a primary prevention programme, including counselling and ergonomic training of working techniques/skills tailored for each company’s specific work-site aimed at preventing back complaints, and a secondary prevention programme that consisted of a quick intervention with easy accessible in-company physical therapy in the origin of (absenteeism due to) back complaints.

Usual care is provided by the general practitioner or occupational physician according to Dutch health care guidelines.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure is the occurrence and duration of LBP and subsequent sickness absence.

Secondary outcome measures

Secondary outcome measures are pain intensity, functional disability due to low back pain complaints, general health and quality of life. The economic evaluation is conducted from a societal perspective and includes both direct and indirect costs due to LBP.

Overall trial start date

15/01/2001

Overall trial end date

15/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

The study population is recruited from companies throughout the Netherlands. Companies who want to take up the programme from the occupational health consultancy that executes the intervention under study within a year are asked to participate in the study.

Inclusion criteria for companies are:
1. Willingness to participate in the study
2. The possibility of forming a control group within the same company with workers with approximately the same physically demanding jobs and high prevalence of musculoskeletal complaints
3. Willingness to concur with randomisation of the intervention and study protocol.

Inclusion criteria for workers:
All workers in the work units of these companies who are working at least 3 days per week, are willing to comply with the research protocol and follow-up measurements are asked to participate in the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

15/01/2001

Recruitment end date

15/08/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center Rotterdam
Rotterdam
3000 DR
Netherlands

Sponsor information

Organisation

Erasmus Medical Center Rotterdam (The Netherlands)

Sponsor details

P.O. Box 1738
Rotterdam
3000 DR
Netherlands

Sponsor type

Research organisation

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17414902

Publication citations

  1. Results

    IJzelenberg H, Meerding WJ, Burdorf A, Effectiveness of a back pain prevention program: a cluster randomized controlled trial in an occupational setting., Spine, 2007, 32, 7, 711-719, doi: 10.1097/01.brs.0000259072.14859.d9.

Additional files

Editorial Notes