FibromyalgiaPhase 2NCT00917176
Occipital Nerve Stimulation in Fibromyalgia
A Phase 2 study testing Occipital nerve stimulation in people with Fibromyalgia, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Occipital nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteBelgium
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fibromyalgia
- Being tested
- Occipital nerve stimulation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occipital nerve stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Effective stimulation | Experimental | Effective stimulation at sub-threshold level Receives: Device: Occipital nerve stimulation |
| Placebo stimulation | Placebo comparator | Stimulation at non-effective strength Receives: Device: Occipital nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores on Visual Analogue Scale (VAS), pain Catastrophizing Scale (PCS), pain vigilance and awareness questionnaire (PVAQ)
Measured: at a weekly base during 10 weeks
Secondary outcomes (1)
Scores on Fatigue and Mood
Measured: at a weekly base, during 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Investigators
- Dirk De Ridder, M.D., PhD., Study chair, University Hospital, AntwerpMark Plazier, M.D., Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917176
- Sponsor's protocol ID
- FMS_ONS_01
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2009
- Last updated
- 10 Jun 2009
- Results posted
- No
Publications
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.
PubMed 30419855
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous C2 Stimulation: Treatment of Fibromyalgia
- ClinicalTrials.gov ID
- NCT00917176
- Acronym / sponsor ID
- FMS_ONS_01
- Conditions
- Fibromyalgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effective stimulation | Experimental | Device: Occipital nerve stimulationEffective stimulation at sub-threshold level |
| Placebo stimulation | Placebo comparator | Device: Occipital nerve stimulationStimulation at non-effective strength |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occipital nerve stimulation | Device | Effective stimulation, Placebo stimulation |
Primary outcome
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
1 secondary outcome
Scores on Fatigue and Mood
Time frame: at a weekly base, during 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2009.
- Derived from this study: PubMed 30419855Ahmed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk De Ridder, M.D., PhD. study chair
University Hospital, Antwerp
Mark Plazier, M.D. principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Occipital nerve stimulation in people with Fibromyalgia, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00917176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2009.