Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Aug 9, 2021

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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)