Occipital Nerve Stimulation in Fibromyalgia
Phase 2
Completed
- Conditions
- Fibromyalgia
- Interventions
- Device: Occipital nerve stimulation
- Registration Number
- NCT00917176
- Lead Sponsor
- University Hospital, Antwerp
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo stimulation Occipital nerve stimulation Stimulation at non-effective strength Effective stimulation Occipital nerve stimulation Effective stimulation at sub-threshold level
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Scores on Fatigue and Mood at a weekly base, during 10 weeks
Trial Locations
- Locations (1)
University Hospital Antwerp
🇧🇪Edegem, Belgium