Condition category
Musculoskeletal Diseases
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
30/06/2009
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

Ms Judith Heinrich

ORCID ID

Contact details

TNO Quality of Life
P.O. Box 718
Hoofddorp
2130 AS
Netherlands
+31 (0)23 55499922
judith.heinrich@tno.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR67

Study information

Scientific title

Acronym

FysiOke

Study hypothesis

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

Medical Ethics Committee approved

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/07/2004

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant 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).

Recruitment start date

01/07/2004

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

TNO Quality of Life
Hoofddorp
2130 AS
Netherlands

Sponsor information

Organisation

TNO Quality of Life (The Netherlands)

Sponsor details

P.O. Box 718
Hoofddorp
2130 AS
Netherlands

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

Interpolis (a Dutch insurance company) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Dutch Ministry of Health, Welfare and Sports (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

1. 2009 results on http://www.ncbi.nlm.nih.gov/pubmed/19549294

Publication citations

  1. Results

    Heinrich J, Anema JR, de Vroome EM, Blatter BM, Effectiveness of physical training for self-employed persons with musculoskeletal disorders: a randomized controlled trial., BMC Public Health, 2009, 9, 200, doi: 10.1186/1471-2458-9-200.

Additional files

Editorial Notes