|- candidate number||1773|
|- NTR Number||NTR406|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||18-okt-2005|
|- Secondary IDs||N/A |
|- Public Title||Fibromyalgia on the move...! Randomised study on the effect and cost-effectiveness of a multidisciplinary part-time daycare intervenion.|
|- Scientific Title||Randomised study on the effect and cost-effectiveness of a multidisciplinary part-time daycare intervention in fibromyalgia patients.|
|- 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.|
|- Healt Condition(s) or Problem(s) studied||Fibromyalgia|
|- Inclusion criteria||1. Recently diagnosed fibromyalgia;|
2. Age 18-65;
3. Be able to read en write Dutch;
4. Physical be able 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.
|- 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;
7. Complicated home situation/Fibromyalgia is not most important problem;
8. Use of supportive equipment for ambulation.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||23-jan-2004|
|- planned closingdate||1-mei-2006|
|- Target number of participants||214|
|- Interventions||1. 12-week multidisciplinary part-time day-care intervention;|
2. 12-week aerobics exercise;
3. Usual care.
|- Primary outcome||1. Social participation;|
2. Medical consumption;
3. Quality of life.
|- Secondary outcome||1. Pain;|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. M.E.A.L. Kroese|
|- CONTACT for SCIENTIFIC QUERIES||Drs. M.E.A.L. Kroese|
|- Sponsor/Initiator ||Academic Hospital Maastricht (azM)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Patients with fibromyalgia, a chronic benign pain syndrome, are referred frequently. An important cause is the fact that a will defined treatment to mange symptoms and pain is lacking. A number of studies have been performed on the effectiveness of a diversity of interventions, but only preliminary support of moderate strength exists for aerobic exercise. Since chronic pain tends to develop into a combination of physical, psychological and social disabilities, the physical rehabilitation for musculoskeletal disorders is getting more and more combined with psychological, behavioural and educational interventions. Several multidisciplinary programs for fibromyalgia are available, mainly in rehabilitation centres. However, only a few studies had been performed on the effectiveness of these treatment and the methodological quality of the studies is low. In addition to this, patients are eligible for such programs not until after trying the whole range of possible treatments in vain. If patients are able to follow the multidisciplinary program in an early stage of their disease, fixation can possibly be prevented. Because of this, a (larger) social drop-out will be averted in term, and medical consumption will decrease and quality of life will increase.|
The overall research questions are:
1.What is the effectiveness of the multidisciplinary part-time day-care intervention in recently diagnosed fibromyalgia patients compared with best care (aerobic exercise) and usual care?
2.What is the cost-effectiveness of the multidisciplinary part-time day-care intervention in recently diagnosed fibromyalgia patients?
For this study, we have used a design in which a random sample is drawn out a ‘natural course cohort’ to create the intervention group. Through this, an unwanted negative influence of the control group has been prevented.
|- Main changes (audit trail)|
|- RECORD||18-okt-2005 - 18-nov-2008|