Cost-effectiveness of physical training for self-employed persons with musculoskeletal disorders: the FysiOke study

ISRCTN	ISRCTN67766245
DOI	https://doi.org/10.1186/ISRCTN67766245
Protocol serial number	NTR67
Sponsor	TNO Quality of Life (The Netherlands)
Funders	Interpolis (a Dutch insurance company) (The Netherlands), The Dutch Ministry of Health, Welfare and Sports (The Netherlands)

Submission date: 12/09/2005
Registration date: 12/09/2005
Last edited: 30/06/2009

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

Ms Judith Heinrich
Scientific

TNO Quality of Life
P.O. Box 718
Hoofddorp
2130 AS
Netherlands

Phone	+31 (0)23 55499922
Email	judith.heinrich@tno.nl

Study information

Primary study design	Interventional
Study design	Randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	FysiOke
Study objectives	To evaluate the cost-effectiveness of physical training in the reduction of musculoskeletal disorders and disability. Both the insurance company and the Dutch government wants to know if this physical training is more cost-effective than usual care. Therefore, we started a randomised controlled trial (RCT) of 300 self-employed persons with musculoskeletal disorders (MSDs).
Ethics approval(s)	Medical Ethics Committee approved
Health condition(s) or problem(s) studied	Musculoskeletal disorders (MSDs)
Intervention	1. Physical training 2. Usual care Participants in the intervention group will receive physical training by a physiotherapist. This tailored training takes place two or three times a week during three months and consists of cardiovascular training, strengthening, relaxation and posture exercises. During an intake meeting each participant is screened for medical or physical contraindications and aspects of motivation. Participants in the control group will receive usual care mostly by general practitioner or physiotherapist (or no treatment at all).
Intervention type	Other
Primary outcome measure(s)	1. Disability 2. Return to work These outcomes are measured at baseline and 6 and 12 months follow-up. The required information becomes available by registration of the insurance company.
Key secondary outcome measure(s)	1. Level of pain 2. Functional restrictions These outcomes are also measured at baseline and 6 and 12 months follow-up. The required information is gathered by self-report of participants through questionnaires.
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	300
Key inclusion criteria	All insured persons submitting a new disability payment because of musculoskeletal disorders and who are eligible for physical training according to standard procedures of Interpolis.
Key exclusion criteria	Insured persons with musculoskeletal disorders indicating a specific treatment, e.g. an operation (for a slipped disk) or an injection (for an inflammation).
Date of first enrolment	01/07/2004
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

TNO Quality of Life

Hoofddorp
2130 AS
Netherlands

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/06/2009		Yes	No