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Occipital Nerve Stimulation in Fibromyalgia

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 10, 2009
Last Update Posted: June 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Antwerp
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.

Condition Intervention Phase
Fibromyalgia Device: Occipital nerve stimulation Phase 2

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subcutaneous C2 Stimulation: Treatment of Fibromyalgia

Resource links provided by NLM:

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Pain scores on Visual Analogue Scale (VAS), pain Catastrophizing Scale (PCS), pain vigilance and awareness questionnaire (PVAQ) [ Time Frame: at a weekly base during 10 weeks ]

Secondary Outcome Measures:
  • Scores on Fatigue and Mood [ Time Frame: at a weekly base, during 10 weeks ]

Arms Assigned Interventions
Experimental: Effective stimulation
Effective stimulation at sub-threshold level
Device: Occipital nerve stimulation
Placebo Comparator: Placebo stimulation
Stimulation at non-effective strength
Device: Occipital nerve stimulation


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917176

University Hospital Antwerp
Edegem, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Study Chair: Dirk De Ridder, M.D., PhD. University Hospital, Antwerp
Principal Investigator: Mark Plazier, M.D. University Hospital, Antwerp
  More Information

Responsible Party: Prof. Dr. Dirk De Ridder, University Hospital Antwerp
ClinicalTrials.gov Identifier: NCT00917176     History of Changes
Other Study ID Numbers: FMS_ONS_01
First Submitted: June 9, 2009
First Posted: June 10, 2009
Last Update Posted: June 10, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases