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Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia

12. august 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10029
        • Icahn School of Medicine at Mount Sinai

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cold water caloric stimulation
50 cc of ice-cold water irrigation into the right ear at 1-2 cc/second, once per participant.
Procedure: Vestibular Caloric Stimulation
Irrigation of the right external ear canal
Andre navne:
  • VCS
  • Cold water caloric stimulation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Numeric Rating Scale (NRS)
Tidsramme: 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.
baseline and 1 week after VCS

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute change in NRS
Tidsramme: baseline and 5, 15 and 30 minutes after VCS
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.
baseline and 5, 15 and 30 minutes after VCS
Percentage of participants with NRS pain scores >= to 30% and 50%
Tidsramme: 30 minutes, 24 hours, 1 week, 2 weeks after VCS
Percentage of patients with change in pain assessed by NRS pain scores > or equal to 30% and 50%.
30 minutes, 24 hours, 1 week, 2 weeks after VCS
Patient Global Impression of Change (PGIC)
Tidsramme: at 1 weeks, 2 weeks and 4 weeks after VCS
Full score from 0-7, with higher score indicating more improvement.
at 1 weeks, 2 weeks and 4 weeks after VCS
Change in Multidimensional Assessment of Fatigue (MAF)
Tidsramme: baseline and at 1, 2 and 4 weeks after VCS
MAF is a 16 item instrument, full scale from 0-50, with higher score indicating more fatigue.
baseline and at 1, 2 and 4 weeks after VCS
Michigan Neuropathy Screening Instrument (MNSI)
Tidsramme: baseline and at 1, 2 and 4 weeks after VCS
15 "yes or no" questions - full score from 0-13, with higher score indicating more neuropathic symptoms.
baseline and at 1, 2 and 4 weeks after VCS
Change in Brief Pain Inventory Short Form 36 (BPI SF36)
Tidsramme: baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
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.
baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
Change in Fibromyalgia Impact Questionnaire (FIQ)
Tidsramme: baseline and at 1, 2 and 4 weeks after VCS
Full scale from 0-100, with higher score indicating a greater impact of fibromyalgia syndrome.
baseline and at 1, 2 and 4 weeks after VCS
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
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.
baseline and at 24 hours, 1 week, 2 week, 4 week after VCS
VCS Tolerability Survey
Tidsramme: 24 hours post VCS
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.
24 hours post VCS
Number of participants willing to trial VCS again
Tidsramme: 24 hours post VCS
Number of participants expressing willingness to trial VCS again
24 hours post VCS
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
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
at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Icahn School of Medicine at Mount Sinai

Efterforskere

  • Ledende efterforsker: Ioannis Tassiulas, MD, Icahn School of Medicine at Mount Sinai

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. marts 2021

Primær færdiggørelse (Faktiske)

2. juli 2021

Studieafslutning (Faktiske)

2. juli 2021

Datoer for studieregistrering

Først indsendt

9. august 2021

Først indsendt, der opfyldte QC-kriterier

9. august 2021

Først opslået (Faktiske)

13. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GCO 20-2730

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Vestibular Caloric Stimulation

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