Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia
12 agosto 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
21
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10029
- Icahn School of Medicine at Mount Sinai
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Numeric Rating Scale (NRS)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Acute change in NRS
Lasso di tempo: 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%
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Ioannis Tassiulas, MD, Icahn School of Medicine at Mount Sinai
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
19 marzo 2021
Completamento primario (Effettivo)
2 luglio 2021
Completamento dello studio (Effettivo)
2 luglio 2021
Date di iscrizione allo studio
Primo inviato
9 agosto 2021
Primo inviato che soddisfa i criteri di controllo qualità
9 agosto 2021
Primo Inserito (Effettivo)
13 agosto 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 agosto 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 agosto 2021
Ultimo verificato
1 agosto 2021
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GCO 20-2730
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .