Condition category
Musculoskeletal Diseases
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
24/07/2013
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 M.E.A.L. Kroese

ORCID ID

Contact details

University Hospital Maastricht
BZe VII - Transmurale Zorg
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3874406
mkroes@adcc.azm.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Fixation of complaints in fibromyalgia patients can be prevented by offering a multidisciplinary intervention in an early stage of the disorder. Because of this, a (larger) social drop-out will be averted in term, and medical consumption will decrease and quality of life will increase.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Fibromyalgia

Intervention

1. 12-week multidisciplinary part-time day-care intervention
2. 12-week aerobics exercise
3. Usual care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Social participation
2. Medical consumption
3. Quality of life

Secondary outcome measures

1. Pain
2. Anxiety
3. Self-efficacy
4. Catastrophying
5. Fatigue
6. Disability

Overall trial start date

23/01/2004

Overall trial end date

01/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Recently diagnosed fibromyalgia
2. Age 18-65
3. Be able to read and write Dutch
4. Be able physically to spend 12 hours a week on therapy
5. Be able to be present at least 85% of the treatment time
6. Motivated into all parts of the treatment program

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

214

Participant exclusion criteria

1. Involved in any litigation concerning disability income
2. Serious psychopathology through which a patient is unsuitable to take part in the group treatment
3. Serious depression (measured by SCL-90)
4. Specific medical diseases for which medical treatment is necessary immediately or through which patients can not take part in the physical therapeutic treatment
5. Addiction problems
6. Pregnancy
7. Complicated home situation/fibromyalgia is not most important problem
8. Use of supportive equipment for ambulation

Recruitment start date

23/01/2004

Recruitment end date

01/05/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Hospital Maastricht
Maastricht
6202 AZ
Netherlands

Sponsor information

Organisation

Academic Hospital Maastricht (AZM) (Netherlands)

Sponsor details

P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3876543
info@azm.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Care Funds (Zorgvernieuwingsgelden) (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

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23053692

Publication citations

  1. Results

    van Eijk-Hustings Y, Kroese M, Tan F, Boonen A, Bessems-Beks M, Landewé R, Challenges in demonstrating the effectiveness of multidisciplinary treatment on quality of life, participation and health care utilisation in patients with fibromyalgia: a randomised controlled trial., Clin. Rheumatol., 2013, 32, 2, 199-209, doi: 10.1007/s10067-012-2100-7.

Additional files

Editorial Notes