Occipital Nerve Stimulation in Fibromyalgia

University Hospital, Antwerp

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Fibromyalgia

Interventions

Occipital nerve stimulationDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Antwerp

Edegem, Belgium

Outcomes

Primary Outcomes

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

Scores on Fatigue and Mood

Time frame: at a weekly base, during 10 weeks

Data from ClinicalTrials.gov

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