Fibromyalgia on the move. Randomised study on the effect and cost-effectiveness of a multidisciplinary part-time daycare intervention.

ISRCTN	ISRCTN32542621
DOI	https://doi.org/10.1186/ISRCTN32542621
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M.E.A.L. Kroese
Scientific

University Hospital Maastricht
BZe VII - Transmurale Zorg
P.O. Box 5800
Maastricht
6202 AZ
Netherlands

Phone	+31 (0)43 3874406
Email	mkroes@adcc.azm.nl

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Fibromyalgia
Intervention	1. 12-week multidisciplinary part-time day-care intervention 2. 12-week aerobics exercise 3. Usual care
Intervention type	Other
Primary outcome measure	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 study start date	23/01/2004
Completion date	01/05/2006

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Not Specified
Target number of participants	214
Key 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
Key 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
Date of first enrolment	23/01/2004
Date of final enrolment	01/05/2006

University Hospital Maastricht

Maastricht
6202 AZ
Netherlands

Academic Hospital Maastricht (AZM) (Netherlands)
Hospital/treatment centre

P.O. Box 5800
Maastricht
6202 AZ
Netherlands

Other

Care Funds (Zorgvernieuwingsgelden) (Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2013		Yes	No