Occipital Nerve Stimulation in Fibromyalgia

June 9, 2009 updated by: University Hospital, Antwerp

Subcutaneous C2 Stimulation: Treatment of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • University Hospital Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at a weekly base during 10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Scores on Fatigue and Mood
Time Frame: at a weekly base, during 10 weeks
at a weekly base, during 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Investigators

  • Study Chair: Dirk De Ridder, M.D., PhD., University Hospital, Antwerp
  • Principal Investigator: Mark Plazier, M.D., University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Estimate)

June 10, 2009

Last Update Submitted That Met QC Criteria

June 9, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMS_ONS_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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