weak magnetic fields against pain in fibromyalgia

Rationale: Fibromyalgia is a common medically unexplained condition with
unexplained pain as a core symptom. A novel intervention, weak TMS with pulsed
electromagnetic fields, here called PEMF, was recently reported to have rapid
painreducing effects. This method is easy to administer and is therefore an
intresting new intervention against unexplained pain.

We aim to study the effects of PEMF on pain in fibromyalgia.

Randomized, stratified and minimised, double-blind placebo controlled
intervention study. Treatment lasts for five weeks. Measurements are made in
the week preceding initiation of treatment, during the treatment period, at the
end of the treatment period and five and fifteen weeks after the end of
treatment.

Intervention (if applicable): One group receives 30 minutes of PEMF treatment
per day for five days per week, for five weeks in a row (PEMF group). The other
group receives placebo (SHAM group) for the same amount of time. In both groups
normal treatment with medication or other forms of behavioural of physical
therapy will be continued as part of standard care.

Patients visit the treatment room for five weeks. Daily visits on working days
lasting one hour each. Therefore in total it takes 25 hours in the treatment
room.
The treatment itself might be experienced as boring by the patients, because
they have to sit still for 30 minutes. Reading is allowed to alleviate this.
No adverse events or risks due to the intervention are expected.
There are two MRI sessions, spread out over 5 weeks. Each session lasts for no
longer than 60 minutes. During the scans patients lie in the MR-scanner, which
is a narrow space and are required to lie still. During certain periods they
perform tasks.
The questionnaires constitute a negligible to mild burden.
No other behaviours are enforced or prohibited.
Patients are allowed to continue their medication and/or psychotherapy during
treatment.