Fibromyalgia Clinical Trial
Official title:
Subcutaneous C2 Stimulation: Treatment of Fibromyalgia
NCT number | NCT00917176 |
Other study ID # | FMS_ONS_01 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | June 9, 2009 |
Last updated | June 9, 2009 |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Antwerp | Edegem |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain scores on Visual Analogue Scale (VAS), pain Catastrophizing Scale (PCS), pain vigilance and awareness questionnaire (PVAQ) | at a weekly base during 10 weeks | No | |
Secondary | Scores on Fatigue and Mood | at a weekly base, during 10 weeks | No |
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