Fibromyalgia
Conditions
Brief summary
The aim of this study is to investigate whether greater occipital nerve stimulation is effective in the treatment of fibromyalgia related pain. The study uses sub sensory threshold stimulation and placebo stimulation in order to investigate whether sub-threshold stimulation is feasible in a placebo controlled study.
Interventions
Sponsors
University Hospital, Antwerp
Study design
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed according to the criteria of the American College of Rheumatology (ACR-90) * Minimally treated with adequate trials during 3 months * Insight of the patient in her disease and capable of understanding and signing an informed consent
Exclusion criteria
* History of severe illness or suffering from severe chronic disease * History of substance abuse, unless treated and in remission during 6 months * Cardiac disease * History of epileptic insults * Psychiatric disorders with psychotic symptoms * Pace maker / defibrillator * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain scores on Visual Analogue Scale (VAS), pain Catastrophizing Scale (PCS), pain vigilance and awareness questionnaire (PVAQ) | at a weekly base during 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Scores on Fatigue and Mood | at a weekly base, during 10 weeks |
Countries
Belgium
Outcome results
None listed