Cost effectiveness of an occupational physical therapy programme on primary and secondary prevention of low back pain: economic evaluation alongside a cluster randomised controlled trial

ISRCTN ISRCTN42542680
DOI https://doi.org/10.1186/ISRCTN42542680
Secondary identifying numbers NTR395
Submission date
02/11/2005
Registration date
02/11/2005
Last edited
29/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr W. IJzelenberg
Scientific

Erasmus Medical Center Rotterdam
Department of Public Health
P.O. Box 1738
Rotterdam
3000 DR
Netherlands

Phone +31 (0)10 4087718
Email w.ijzelenberg@erasmusmc.nl

Study information

Study designEconomic evaluation alongside a cluster randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study objectivesWhat 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(s)Received from a local medical ethics committee
Health condition(s) or problem(s) studiedLow back pain (LBP)
InterventionThe 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 typeOther
Primary outcome measureThe primary outcome measure is the occurrence and duration of LBP and subsequent sickness absence.
Secondary outcome measuresSecondary 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 study start date15/01/2001
Completion date15/08/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants500
Key inclusion criteriaThe 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.
Key exclusion criteriaDoes not comply with the above inclusion criteria
Date of first enrolment15/01/2001
Date of final enrolment15/08/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Center Rotterdam
Rotterdam
3000 DR
Netherlands

Sponsor information

Erasmus Medical Center Rotterdam (The Netherlands)
Research organisation

P.O. Box 1738
Rotterdam
3000 DR
Netherlands

ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2007 Yes No