Occipital Nerve Stimulation in Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00917176
First received: June 9, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scores on Fatigue and Mood [ Time Frame: at a weekly base, during 10 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917176

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

No publications provided

Responsible Party: Prof. Dr. Dirk De Ridder, University Hospital Antwerp
ClinicalTrials.gov Identifier: NCT00917176     History of Changes
Other Study ID Numbers: FMS_ONS_01
Study First Received: June 9, 2009
Last Updated: June 9, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on September 18, 2014