FibromyalgiaNCT05004194
Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia
A study testing Vestibular Caloric Stimulation in people with Fibromyalgia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The management of chronic pains is challenging and fraught with limitations. Fibromyalgia is a common pain disorder characterized by chronic widespread pains, associated with fatigue and impaired quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Vestibular Caloric Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2021to 2 Jul 2021
- 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
- At least 18 years old with ability to comprehend and consent to protocol.
- Diagnosis of fibromyalgia by American College of Rheumatology (ACR) criteria (questionnaire).
- At least a 4/10 baseline on the visual analogue pain scale (VAS).
- Stable fibromyalgia medications for at least 4 weeks.
- Owns or has access to a smart phone or computer to complete outcome measures.
Who cannot join
- Use of opioids
- Otitis externa or media within the past six months.
- Current ear pain with or without other symptoms of otitis externa.
- History of tympanic membrane rupture or surgery.
- Current pregnancy.
- Inability to lay supine for 30 minutes.
Show all 14Show fewer
- Limited decision making capacity.
- Engaged in litigation, currently or prior, related to FMS.
- Inability to commute to clinic once.
- Primary language not English.
- Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study
- Treatment with the medication meclizine for vertigo
- History of seizures
- Diagnosis of bipolar disorder (treated or untreated)
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia: An Open Label Pilot Study
The management of chronic pains is challenging and fraught with limitations. Fibromyalgia is a common pain disorder characterized by chronic widespread pains, associated with fatigue and impaired quality of life. Fibromyalgia affects millions of people and is among the most common reasons for consulting with a rheumatologist. The food and drug administration (FDA) approved three medications to treat fibromyalgia, though there are many patients for whom these medications are ineffective, poorly tolerated or cost-prohibitive. Accordingly, there exists a need for novel therapeutics.
The researchers would like to test the therapeutic efficacy of a non-pharmacologic non-interventional bedside technique called vestibular caloric stimulation (VCS). VCS, irrigating the external ear canal with water, is a simple, non-invasive, cost-free procedure with preliminary data suggesting potential for improving pain. VCS is a form of neuromodulation and there are anatomically defined pathways elucidated to help explain how this works. There currently exists limited data on the topic, only case reports and case series. Given a clear need for additional therapeutics in many patients with fibromyalgia, the researchers have elected to conduct this trial.
Read the detailed description
This is an open label pilot study testing the potential therapeutic efficacy of vestibulocortical stimulation via cold water calorics in fibromyalgia. The trial will entail 6 weeks of total involvement for each participant including 3 weeks of active participation, with 4 weeks follow up: the irrigation happens at the beginning of week 2, so 4 weeks later is week 6.
- Conditions
- Fibromyalgia
- Being tested
- Vestibular Caloric Stimulation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Caloric StimulationProcedure or surgery
Also called VCS, Cold water caloric stimulation
Irrigation of the right external ear canal
| Study group | Role | What they receive |
|---|---|---|
| Cold water caloric stimulation | Experimental | 50 cc of ice-cold water irrigation into the right ear at 1-2 cc/second, once per participant. Receives: Procedure: Vestibular Caloric Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Rating Scale (NRS)
Change in average diary pain scores assessed by daily report on a 11 point numeric rating scale at 1 week after VCS as compared to baseline. Full scale range from 0-10, higher score indicates more pain.
Measured: baseline and 1 week after VCS
Secondary outcomes (11)
Acute change in NRS
Acute effect of VCS assessed by acute change in pain scores post VCS 5, 15 and 30 minutes post irrigation compared to baseline. Full scale range from 0-10, higher score indicates more pain.
Measured: baseline and 5, 15 and 30 minutes after VCS
Percentage of participants with NRS pain scores >= to 30% and 50%
Percentage of patients with change in pain assessed by NRS pain scores > or equal to 30% and 50%.
Measured: 30 minutes, 24 hours, 1 week, 2 weeks after VCS
Patient Global Impression of Change (PGIC)
Full score from 0-7, with higher score indicating more improvement.
Measured: at 1 weeks, 2 weeks and 4 weeks after VCS
Change in Multidimensional Assessment of Fatigue (MAF)
MAF is a 16 item instrument, full scale from 0-50, with higher score indicating more fatigue.
Measured: baseline and at 1, 2 and 4 weeks after VCS
Michigan Neuropathy Screening Instrument (MNSI)
15 "yes or no" questions - full score from 0-13, with higher score indicating more neuropathic symptoms.
Measured: baseline and at 1, 2 and 4 weeks after VCS
Change in Brief Pain Inventory Short Form 36 (BPI SF36)
A 9-item instrument with total score from 0 to 10, with higher score indicating worse outcomes. Will exclude question 2 which is a diagram and question 7 which asks about medications.
Measured: baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
Change in Fibromyalgia Impact Questionnaire (FIQ)
Full scale from 0-100, with higher score indicating a greater impact of fibromyalgia syndrome.
Measured: baseline and at 1, 2 and 4 weeks after VCS
Change in Numeric Rating Scale (NRS) for pain in different regions of the body
Pain measured on a numeric rating scale in different regions of the body: the left upper extremity, right upper extremity, left lower extremity, right lower extremity, front of torso, back of torso, head/neck. Full scale range from 0-10, higher score indicates more pain.
Measured: baseline and at 24 hours, 1 week, 2 week, 4 week after VCS
VCS Tolerability Survey
A seventeen question tolerability instrument developed specifically for caloric stimulation to assess tolerability by measuring the frequency and intensity of headaches, nausea, and vertigo. the tolerability scale does not have a total score just individual questions re headache nausea vertigo discomfort and grades intensities rated on a 0-10 scale, higher numbers reflecting higher severity of symptoms.
Measured: 24 hours post VCS
Number of participants willing to trial VCS again
Number of participants expressing willingness to trial VCS again
Measured: 24 hours post VCS
Change in Subjective Overall Well Being Scale
Subjective Overall Well Being Scale is a 11 point scale with full scale from 0-10, with higher score reflecting the best possible overall subjective disposition
Measured: at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start19 Mar 2021
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
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 Icahn School of Medicine at Mount SinaiThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- An open label non-randomized pilot trial
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Tassiulas, Icahn School of Medicine at Mount Sinai
- Investigators
- Ioannis Tassiulas, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004194
- Sponsor's protocol ID
- GCO 20-2730
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia: An Open Label Pilot Study
- ClinicalTrials.gov ID
- NCT05004194
- Acronym / sponsor ID
- GCO 20-2730
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 13 Aug 2021 (actual)
- 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 management of chronic pains is challenging and fraught with limitations. Fibromyalgia is a common pain disorder characterized by chronic widespread pains, associated with fatigue and impaired quality of life. Fibromyalgia affects millions of people and is among the most common reasons for consulting with a rheumatologist. The food and drug administration (FDA) approved three medications to treat fibromyalgia, though there are many patients for whom these medications are ineffective, poorly tolerated or cost-prohibitive. Accordingly, there exists a need for novel therapeutics.
The researchers would like to test the therapeutic efficacy of a non-pharmacologic non-interventional bedside technique called vestibular caloric stimulation (VCS). VCS, irrigating the external ear canal with water, is a simple, non-invasive, cost-free procedure with preliminary data suggesting potential for improving pain. VCS is a form of neuromodulation and there are anatomically defined pathways elucidated to help explain how this works. There currently exists limited data on the topic, only case reports and case series. Given a clear need for additional therapeutics in many patients with fibromyalgia, the researchers have elected to conduct this trial.
Detailed description
This is an open label pilot study testing the potential therapeutic efficacy of vestibulocortical stimulation via cold water calorics in fibromyalgia. The trial will entail 6 weeks of total involvement for each participant including 3 weeks of active participation, with 4 weeks follow up: the irrigation happens at the beginning of week 2, so 4 weeks later is week 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open label non-randomized pilot trial
| Arm | Type | Receives |
|---|---|---|
| Cold water caloric stimulation | Experimental | Procedure: Vestibular Caloric Stimulation50 cc of ice-cold water irrigation into the right ear at 1-2 cc/second, once per participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old with ability to comprehend and consent to protocol.
- Diagnosis of fibromyalgia by American College of Rheumatology (ACR) criteria (questionnaire).
- At least a 4/10 baseline on the visual analogue pain scale (VAS).
- Stable fibromyalgia medications for at least 4 weeks.
- Owns or has access to a smart phone or computer to complete outcome measures.
Key exclusion criteria (14 listed)
- Use of opioids
- Otitis externa or media within the past six months.
- Current ear pain with or without other symptoms of otitis externa.
- History of tympanic membrane rupture or surgery.
- Current pregnancy.
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 |
|---|---|---|
| Vestibular Caloric StimulationAlso: VCS, Cold water caloric stimulationIrrigation of the right external ear canal | Procedure or surgery | Cold water caloric stimulation |
Primary outcome
Change in Numeric Rating Scale (NRS)
Time frame: baseline and 1 week after VCS
Change in average diary pain scores assessed by daily report on a 11 point numeric rating scale at 1 week after VCS as compared to baseline. Full scale range from 0-10, higher score indicates more pain.
11 secondary outcomes
Acute change in NRS
Time frame: baseline and 5, 15 and 30 minutes after VCS
Percentage of participants with NRS pain scores >= to 30% and 50%
Time frame: 30 minutes, 24 hours, 1 week, 2 weeks after VCS
Patient Global Impression of Change (PGIC)
Time frame: at 1 weeks, 2 weeks and 4 weeks after VCS
Change in Multidimensional Assessment of Fatigue (MAF)
Time frame: baseline and at 1, 2 and 4 weeks after VCS
Michigan Neuropathy Screening Instrument (MNSI)
Time frame: baseline and at 1, 2 and 4 weeks after VCS
Change in Brief Pain Inventory Short Form 36 (BPI SF36)
Time frame: baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
Change in Fibromyalgia Impact Questionnaire (FIQ)
Time frame: baseline and at 1, 2 and 4 weeks after VCS
Change in Numeric Rating Scale (NRS) for pain in different regions of the body
Time frame: baseline and at 24 hours, 1 week, 2 week, 4 week after VCS
VCS Tolerability Survey
Time frame: 24 hours post VCS
Number of participants willing to trial VCS again
Time frame: 24 hours post VCS
Change in Subjective Overall Well Being Scale
Time frame: at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative
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 19 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Ioannis Tassiulas, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Caloric Stimulation in people with Fibromyalgia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 5 inclusion and 14 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 19 Aug 2021. 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 United States. 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. 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?
Change in Numeric Rating Scale (NRS) (time frame: baseline and 1 week after VCS). 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 19 Aug 2021.