Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia
12 augustus 2021 bijgewerkt door: Ioannis Tassiulas, Icahn School of Medicine at Mount Sinai
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
21
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10029
- Icahn School of Medicine at Mount Sinai
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Cold water caloric stimulation
50 cc of ice-cold water irrigation into the right ear at 1-2 cc/second, once per participant.
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Irrigation of the right external ear canal
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Numeric Rating Scale (NRS)
Tijdsspanne: baseline and 1 week after VCS
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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.
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baseline and 1 week after VCS
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Acute change in NRS
Tijdsspanne: baseline and 5, 15 and 30 minutes after VCS
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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.
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baseline and 5, 15 and 30 minutes after VCS
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Percentage of participants with NRS pain scores >= to 30% and 50%
Tijdsspanne: 30 minutes, 24 hours, 1 week, 2 weeks after VCS
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Percentage of patients with change in pain assessed by NRS pain scores > or equal to 30% and 50%.
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30 minutes, 24 hours, 1 week, 2 weeks after VCS
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Patient Global Impression of Change (PGIC)
Tijdsspanne: at 1 weeks, 2 weeks and 4 weeks after VCS
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Full score from 0-7, with higher score indicating more improvement.
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at 1 weeks, 2 weeks and 4 weeks after VCS
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Change in Multidimensional Assessment of Fatigue (MAF)
Tijdsspanne: baseline and at 1, 2 and 4 weeks after VCS
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MAF is a 16 item instrument, full scale from 0-50, with higher score indicating more fatigue.
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baseline and at 1, 2 and 4 weeks after VCS
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Michigan Neuropathy Screening Instrument (MNSI)
Tijdsspanne: baseline and at 1, 2 and 4 weeks after VCS
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15 "yes or no" questions - full score from 0-13, with higher score indicating more neuropathic symptoms.
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baseline and at 1, 2 and 4 weeks after VCS
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Change in Brief Pain Inventory Short Form 36 (BPI SF36)
Tijdsspanne: baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
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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.
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baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
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Change in Fibromyalgia Impact Questionnaire (FIQ)
Tijdsspanne: baseline and at 1, 2 and 4 weeks after VCS
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Full scale from 0-100, with higher score indicating a greater impact of fibromyalgia syndrome.
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baseline and at 1, 2 and 4 weeks after VCS
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Change in Numeric Rating Scale (NRS) for pain in different regions of the body
Tijdsspanne: baseline and at 24 hours, 1 week, 2 week, 4 week after VCS
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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.
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baseline and at 24 hours, 1 week, 2 week, 4 week after VCS
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VCS Tolerability Survey
Tijdsspanne: 24 hours post VCS
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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.
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24 hours post VCS
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Number of participants willing to trial VCS again
Tijdsspanne: 24 hours post VCS
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Number of participants expressing willingness to trial VCS again
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24 hours post VCS
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Change in Subjective Overall Well Being Scale
Tijdsspanne: at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative
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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
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at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Ioannis Tassiulas, MD, Icahn School of Medicine at Mount Sinai
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
19 maart 2021
Primaire voltooiing (Werkelijk)
2 juli 2021
Studie voltooiing (Werkelijk)
2 juli 2021
Studieregistratiedata
Eerst ingediend
9 augustus 2021
Eerst ingediend dat voldeed aan de QC-criteria
9 augustus 2021
Eerst geplaatst (Werkelijk)
13 augustus 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 augustus 2021
Laatste update ingediend die voldeed aan QC-criteria
12 augustus 2021
Laatst geverifieerd
1 augustus 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GCO 20-2730
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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