Occipital Nerve Stimulation in Fibromyalgia

NCT ID: NCT00917176

Last Updated: 2009-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Effective stimulation

Effective stimulation at sub-threshold level

Group Type EXPERIMENTAL

Occipital nerve stimulation

Intervention Type DEVICE

Placebo stimulation

Stimulation at non-effective strength

Group Type PLACEBO_COMPARATOR

Occipital nerve stimulation

Intervention Type DEVICE

Interventions

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Occipital nerve stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Antwerp

Principal Investigators

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Dirk De Ridder, M.D., PhD.

Role: STUDY_CHAIR

University Hospital, Antwerp

Mark Plazier, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

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University Hospital Antwerp

Edegem, , Belgium

Site Status

Countries

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Belgium

References

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Ahmed S, Plazier M, Ost J, Stassijns G, Deleye S, Ceyssens S, Dupont P, Stroobants S, Staelens S, De Ridder D, Vanneste S. The effect of occipital nerve field stimulation on the descending pain pathway in patients with fibromyalgia: a water PET and EEG imaging study. BMC Neurol. 2018 Nov 12;18(1):191. doi: 10.1186/s12883-018-1190-5.

Reference Type DERIVED
PMID: 30419855 (View on PubMed)

Other Identifiers

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FMS_ONS_01

Identifier Type: -

Identifier Source: org_study_id

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