FibromyalgiaNCT01298609
Occipital Nerve (C2) Stimulation in the Treatment of Fibromyalgia
A study testing Occipital Stimulation in people with Fibromyalgia, run by Abbott Medical Devices at 1 site in Belgium.
Trial summary
The study is designed as a prospective, randomized, double-blind, single center study with a 6 month duration post permanent system implantation. Forty patients will be implanted. During trial stimulation, patients will be randomized into one of two study arms for two weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Occipital Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2010to Jan 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients able to provide informed consent to participate in the study;
- Patient has had chronic widespread pain for at least 3 months in all 4 body quadrants;
- Patient has at least 11 out of 18 tender points based on the tender points examination;
- Patient has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to drugs, physical therapy, acupuncture, etc.);
- Patient medication has remained stable for at least 4 weeks prior to baseline data collection;
- Psychological screening has been completed and the patient has been cleared by a psychologist as a suitable study candidate;
- Patient agrees not to add or increase medication throughout the randomization trial period of the study;
- Patient is willing to cooperate with the study requirements including compliance with the treatment regimen and completion of all office visits.
Who cannot join
- Patient has current evidence of any psychiatric disorder, as documented by the DSM-IV-TR criteria with psychotic characteristics, (e.g. bipolar disorder, major depressive disorder);
- Patient has been diagnosed with any disease mimicking the symptoms of the Fibromyalgia Syndrome (e.g. Epstein Barr, autoimmune diseases, etc.) that is not currently being treated or has not been stable for at least 6 months;
- Patient is currently in active menopause;
- Patient has been diagnosed with sleep apnea and is not currently involved in a treatment regime;
- Patient has a history of substance abuse or substance dependency in the past 6 months prior to baseline data collection;
- Patient currently participating in another clinical study;
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- Patient with demand-type cardiac pacemakers, an infusion pump or any implantable neurostimulator device;
- Patient is likely to require an MRI evaluation in the future;
- Patient is not willing to maintain current medication regimen;
- Female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Pilot Study to Examine the Efficacy of Greater Occipital Nerve (C2) Stimulation in the Treatment of Fibromyalgia
The study is designed as a prospective, randomized, double-blind, single center study with a 6 month duration post permanent system implantation. Forty patients will be implanted.
During trial stimulation, patients will be randomized into one of two study arms for two weeks. Crossover will occur at the 2 week study visit to the opposite group. After completion of these two arms, every patient will subsequently complete participation in the third study arm.
After completion of the third arm, patients will be evaluated to determine if they are a positive responder responder. If so, the patient will have the option of obtaining the permanent implant.
- Conditions
- Fibromyalgia
- Being tested
- Occipital Stimulation
- Keywords
- Fibromyalgia, 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 StimulationDevice
Occipital Nerve Stimulation will be used in each study arm using the Eon Mini neuromodulation system
| Study group | Role | What they receive |
|---|---|---|
| Suprathreshold Stimulation | Active comparator | Patients will be stimulated at supra-sensory threshold levels for two weeks using occipital stimulation Receives: Device: Occipital Stimulation |
| minimal stimulation | Sham comparator | Patients will be stimulated at minimal stimulation for two weeks using occipital stimulation Receives: Device: Occipital Stimulation |
| Subthreshold Stimulation | Active comparator | Patients will be stimulated at sub-sensory threshold stimulation for two weeks using occipital stimulation Receives: Device: Occipital Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire (FIQ)
The Fibromyalgia Impact Questionnaire (FIQ) is a self administered scale that was developed to measure fibromyalgia patient status, progress and outcomes. It measures the components of health that are most affected by fibromyalgia. The maximum score is 100 and a higher score indicates a greater impact of the syndrome on the person.
The change in the Fibromyalgia Impact Questionnaire (FIQ) will be analyzed and reported.
Measured: End of 6 week stimulation trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startJun 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roni Diaz, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298609
- Sponsor's protocol ID
- CRD_545
- Status last verified
- Jan 2019
- First submitted
- 14 Feb 2011
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Study to Examine the Efficacy of Greater Occipital Nerve (C2) Stimulation in the Treatment of Fibromyalgia
- ClinicalTrials.gov ID
- NCT01298609
- Acronym / sponsor ID
- CRD_545
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Occipital Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 Feb 2011 (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 study is designed as a prospective, randomized, double-blind, single center study with a 6 month duration post permanent system implantation. Forty patients will be implanted.
During trial stimulation, patients will be randomized into one of two study arms for two weeks. Crossover will occur at the 2 week study visit to the opposite group. After completion of these two arms, every patient will subsequently complete participation in the third study arm.
After completion of the third arm, patients will be evaluated to determine if they are a positive responder responder. If so, the patient will have the option of obtaining the permanent implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suprathreshold Stimulation | Active comparator | Device: Occipital StimulationPatients will be stimulated at supra-sensory threshold levels for two weeks using occipital stimulation |
| minimal stimulation | Sham comparator | Device: Occipital StimulationPatients will be stimulated at minimal stimulation for two weeks using occipital stimulation |
| Subthreshold Stimulation | Active comparator | Device: Occipital StimulationPatients will be stimulated at sub-sensory threshold stimulation for two weeks using occipital stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients able to provide informed consent to participate in the study;
- Patient has had chronic widespread pain for at least 3 months in all 4 body quadrants;
- Patient has at least 11 out of 18 tender points based on the tender points examination;
- Patient has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to drugs, physical therapy, acupuncture, etc.);
- Patient medication has remained stable for at least 4 weeks prior to baseline data collection;
Key exclusion criteria (10 listed)
- Patient has current evidence of any psychiatric disorder, as documented by the DSM-IV-TR criteria with psychotic characteristics, (e.g. bipolar disorder, major depressive disorder);
- Patient has been diagnosed with any disease mimicking the symptoms of the Fibromyalgia Syndrome (e.g. Epstein Barr, autoimmune diseases, etc.) that is not currently being treated or has not been stable for at least 6 months;
- Patient is currently in active menopause;
- Patient has been diagnosed with sleep apnea and is not currently involved in a treatment regime;
- Patient has a history of substance abuse or substance dependency in the past 6 months prior to baseline data collection;
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 StimulationOccipital Nerve Stimulation will be used in each study arm using the Eon Mini neuromodulation system | Device | Subthreshold Stimulation, Suprathreshold Stimulation, minimal stimulation |
Primary outcome
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: End of 6 week stimulation trial
The Fibromyalgia Impact Questionnaire (FIQ) is a self administered scale that was developed to measure fibromyalgia patient status, progress and outcomes. It measures the components of health that are most affected by fibromyalgia. The maximum score is 100 and a higher score indicates a greater impact of the syndrome on the person. The change in the Fibromyalgia Impact Questionnaire (FIQ) will be analyzed and reported.
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 30 Jan 2019.
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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.
Roni Diaz study director
Abbott Medical Devices
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occipital Stimulation in people with Fibromyalgia, run by Abbott Medical Devices 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 8 inclusion and 10 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 30 Jan 2019. 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.
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?
Fibromyalgia Impact Questionnaire (FIQ) (time frame: End of 6 week stimulation trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2019.