Condition category
Musculoskeletal Diseases
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
20/10/2008
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

Dr Eline Meijer

ORCID ID

Contact details

Academic Medical Centre
Universiteit van Amsterdam
Coronel Institute for Occupational and Environmental Health
P.O. Box 22700
Amsterdam
1100 DE
Netherlands
+31 (0)20 566 5325
e.m.meijer@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw number: 3140.0006; NTR76

Study information

Scientific title

Acronym

Study hypothesis

To determine the effectiveness and cost-effectiveness of a return-to-work outpatient multidisciplinary treatment programme for sick-listed workers with non-specific upper extremity musculoskeletal complaints.

Ethics approval

Received from the local medical ethics committee

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

Chronic non-specific musculoskeletal complaints in the upper extremity

Intervention

1. Multidisciplinary treatment program of 13 full-time days, carried out by a commercial rehabilitation centre: each day's schedule consisted of four (1.5 hour) sessions: one session was dedicated to personal effectiveness (psychologist), one to return-to-work (reintegration expert) and two sessions enclosed physical training (physical therapist), including activities outside the building and individual counselling sessions. Patients were treated in groups of about eight individuals.
2. Usual care; supervision by occupational health services: usual care was coordinated by the occupational physician at the occupational health services. Usual care could include treatment at the workplace and in the regular health care system, initiated by a general practitioner, or medical specialist.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Return to regular work and costs.

Secondary outcome measures

1. Pain
2. Other complaints such as paraesthesia, stiffness, coldness
3. Process evaluation:
3.1. Grip strength
3.2. Disability
3.3. Physical functioning
3.4. Kinesiophobia

Overall trial start date

01/11/2001

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Bank employees in the Netherlands or workers at one of the two universities in Amsterdam
2. With non-specific upper extremity musculoskeletal disorders
3. Employment on a contract of at least 50% of full-time working hours
4. Sick leave for over 50% of the contractual hours during a period between four and 20 weeks
5. Aged between 18 and 65 years
6. Required to comprehend and have communication skills in Dutch

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

38

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/11/2001

Recruitment end date

01/01/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1100 DE
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Coronel Institute for Occupational and Environmental Health
P.O. Box 22700
Amsterdam
1100 DE
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Research organisation

Funder name

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/16506042

Publication citations

  1. Results

    Meijer EM, Sluiter JK, Heyma A, Sadiraj K, Frings-Dresen MH, Cost-effectiveness of multidisciplinary treatment in sick-listed patients with upper extremity musculoskeletal disorders: a randomized, controlled trial with one-year follow-up., Int Arch Occup Environ Health, 2006, 79, 8, 654-664, doi: 10.1007/s00420-006-0098-3.

Additional files

Editorial Notes