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
-
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.