|- candidate number||0|
|- NTR Number||NTR67|
|- Date ISRCTN created||12-sep-2005|
|- date ISRCTN requested||15-aug-2005|
|- Date Registered NTR||6-jul-2005|
|- Secondary IDs||N/A |
|- Public Title||Cost-effectiveness of physical training for self-employed persons with musculoskeletal disorders: the FysiOke study.|
|- Scientific Title||Cost-effectiveness of physical training for self-employed persons with musculoskeletal disorders: the FysiOke study.|
|- Healt Condition(s) or Problem(s) studied||Musculoskeletal disorders (MSDs)|
|- 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.|
|- 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).|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2004|
|- planned closingdate||31-dec-2007|
|- Target number of participants||300|
|- Interventions||1. Psysical training; |
2. Usual care.
Participants in the intervention group will receive physical training by a physiotherapist. This tailored training takes place 2 or 3 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 contra indications and aspects of motivation. Participants in the control group will receive usual care mostly by general practitioner or physiotherapist (or no treatment at all).
|- Primary outcome||Disability and 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||Level of pain and 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.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc. Judith Heinrich|
|- CONTACT for SCIENTIFIC QUERIES|| Birgitte Blatter|
|- Sponsor/Initiator ||TNO Quality of Life (Work and Employment)|
(Source(s) of Monetary or Material Support)
|Interpolis (a Dutch insurance company), Dutch Ministry of Health, Welfare and Sport|
|- Brief summary||Objective: |
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 MSDs. Participants are randomly assigned to either physical training, or usual care. Outcome measures are level of pain, functional restrictions, disability and return-to-work. Data are collected by questionnaire at baseline and at 6 and 12 months follow-up. These questionnaires contain questions on kind of job, physical and mental workload (VBA), type of complaints (Kuorinka), level of pain (VAS), functional restrictions (NDI, QBPDS), fear of movement (Tampa), treatment, return-to-work, general health and demographic variables. Additionally, data are derived from the insurance company (disability, costs) and physical training institutes (compliance). Besides, we started a cohort of persons who do not want to take part in the RCT but are willing to fill in the questionnaires. This gives us the opportunity to add these persons to the RCT population when possible or to change the study design when necessary.
Anticipated trial start date:
The study has started in July 2004, but inclusion of participants started at November 1th 2004.
At August 10th 2005 91 participants were included in the study.
|- Main changes (audit trail)|
|- RECORD||8-aug-2005 - 18-jan-2010|