Occipital Nerve Stimulation in Fibromyalgia

Antwerp University Hospital (UZA)

Status and phase: Completed; Phase 2

Conditions: Fibromyalgia

Treatments: Device: Occipital nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00917176

FMS_ONS_01

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups, including a placebo group

Effective stimulation

Experimental group

Description:

Effective stimulation at sub-threshold level

Treatment:

Device: Occipital nerve stimulation

Placebo stimulation

Placebo Comparator group

Description:

Stimulation at non-effective strength

Treatment:

Device: Occipital nerve stimulation