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Occipital Nerve Stimulation in Fibromyalgia

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. Identifier: NCT00917176
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : June 10, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Occipital nerve stimulation Phase 2

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Study Type : Interventional  (Clinical Trial)
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 the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Scores on Fatigue and Mood [ Time Frame: at a weekly base, during 10 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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 identifier (NCT number): NCT00917176

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University Hospital Antwerp
Edegem, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
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Study Chair: Dirk De Ridder, M.D., PhD. University Hospital, Antwerp
Principal Investigator: Mark Plazier, M.D. University Hospital, Antwerp
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. Dirk De Ridder, University Hospital Antwerp Identifier: NCT00917176    
Other Study ID Numbers: FMS_ONS_01
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: June 10, 2009
Last Verified: June 2009
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases