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Completed

NCT Number: NCT00917176

Occipital Nerve Stimulation in Fibromyalgia

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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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Antwerp

Edegem, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occipital nerve stimulation

Device

Primary outcomes

  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 outcomes

  1. Scores on Fatigue and Mood

    Time frame: at a weekly base, during 10 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

Subcutaneous C2 Stimulation: Treatment of Fibromyalgia

Important dates

First posted
Jun 10, 2009
Registry last updated
Jun 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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