Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia
12. august 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
21
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New York
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New York, New York, Forente stater, 10029
- Icahn School of Medicine at Mount Sinai
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Numeric Rating Scale (NRS)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Acute change in NRS
Tidsramme: 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%
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Ioannis Tassiulas, MD, Icahn School of Medicine at Mount Sinai
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. mars 2021
Primær fullføring (Faktiske)
2. juli 2021
Studiet fullført (Faktiske)
2. juli 2021
Datoer for studieregistrering
Først innsendt
9. august 2021
Først innsendt som oppfylte QC-kriteriene
9. august 2021
Først lagt ut (Faktiske)
13. august 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. august 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. august 2021
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GCO 20-2730
Plan for individuelle deltakerdata (IPD)
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NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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