Cost-effectiveness of physical training for self-employed persons with musculoskeletal disorders: the FysiOke study
| ISRCTN | ISRCTN67766245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67766245 |
| Secondary identifying numbers | NTR67 |
- 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
Scientific
TNO Quality of Life
P.O. Box 718
Hoofddorp
2130 AS
Netherlands
| Phone | +31 (0)23 55499922 |
|---|---|
| judith.heinrich@tno.nl |
Study information
| Study design | Randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/07/2004 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
2130 AS
Netherlands
Sponsor information
TNO Quality of Life (The Netherlands)
Research organisation
Research organisation
P.O. Box 718
Hoofddorp
2130 AS
Netherlands
"ROR" |
https://ror.org/01bnjb948 |
|---|
Funders
Funder type
Government
Interpolis (a Dutch insurance company) (The Netherlands)
No information available
The Dutch Ministry of Health, Welfare and Sports (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
