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Occipital Nerve Stimulation in Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Occipital nerve stimulation
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University Hospital Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Effective stimulation

Placebo stimulation

Arm Description

Effective stimulation at sub-threshold level

Stimulation at non-effective strength

Outcomes

Primary Outcome Measures

Pain scores on Visual Analogue Scale (VAS), pain Catastrophizing Scale (PCS), pain vigilance and awareness questionnaire (PVAQ)

Secondary Outcome Measures

Scores on Fatigue and Mood

Full Information

First Posted
June 9, 2009
Last Updated
June 9, 2009
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT00917176
Brief Title
Occipital Nerve Stimulation in Fibromyalgia
Official Title
Subcutaneous C2 Stimulation: Treatment of Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Antwerp

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor

8. Arms, Groups, and Interventions

Arm Title
Effective stimulation
Arm Type
Experimental
Arm Description
Effective stimulation at sub-threshold level
Arm Title
Placebo stimulation
Arm Type
Placebo Comparator
Arm Description
Stimulation at non-effective strength
Intervention Type
Device
Intervention Name(s)
Occipital nerve stimulation
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Scores on Fatigue and Mood
Time Frame
at a weekly base, during 10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk De Ridder, M.D., PhD.
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mark Plazier, M.D.
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Antwerp
City
Edegem
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
30419855
Citation
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.
Results Reference
derived

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Occipital Nerve Stimulation in Fibromyalgia

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