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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Effective stimulation | Experimental | Effective stimulation at sub-threshold level |
|
| Placebo stimulation | Placebo Comparator | Stimulation at non-effective strength |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occipital nerve stimulation | Device |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Scores on Fatigue and Mood | at a weekly base, during 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk De Ridder, M.D., PhD. | University Hospital, Antwerp | Study Chair |
| Mark Plazier, M.D. | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Edegem | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30419855 | Derived | Ahmed S, Plazier M, Ost J, Stassijns G, Deleye S, Ceyssens S, Dupont P, Stroobants S, Staelens S, De Ridder D, Vanneste S. The effect of occipital nerve field stimulation on the descending pain pathway in patients with fibromyalgia: a water PET and EEG imaging study. BMC Neurol. 2018 Nov 12;18(1):191. doi: 10.1186/s12883-018-1190-5. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| D009422 |
| Nervous System Diseases |