Vestibular Innovation in Pain 2

Официальное название

Vestibular Innovation in Pain: A Randomized Controlled Trial

Обзор

Fibromyalgia is the most common centralized pain disorder, affecting up to 3% of the population. Current treatments are incompletely effective, often poorly tolerated, and costly: there remains an urgent need for novel, effective, and well-tolerated therapy. Preliminary data suggests that vestibulocortical stimulation (VCS), or irrigating the external ear canal with temperate water, could rapidly improve pain and quality of life in this cohort. The VIPR trial will assess the efficacy of a single session of VCS - a safe \& cost-effective bedside technique using a plastic syringe and temperate water - relative to sham in treating pain \& improving quality of life using validated patient-reported outcomes.

Вмешательства

• Процедура Vestibulocortical Stimulation
  VCS is a non-invasive bedside procedure using temperate water, and a plastic syringe (no needles). With the participant laying supine, temperate water is irrigated into the external ear canal at 1-2 cc/second.

Первичные конечные точки

• Change in Pain numeric rating scale (NRS) [Срок оценки: Baseline and 1 week]

Вторичные конечные точки (6)

• Change in Pain numeric rating scale (NRS) [Срок оценки: 30 minutes, 24 hours, 2 weeks, 3 weeks, 4 weeks]
• Overall Well Being Scale [Срок оценки: 30 minutes]
• Patient Global Impression of Change (PGIC) [Срок оценки: 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks]
• Brief Pain Inventory (Short-Form; BPI-SF) [Срок оценки: 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks]
• Patient Reported Outcomes Measurement Information System (PROMIS-29) [Срок оценки: 1 week, 2 weeks, 3 weeks, 4 weeks]
• Composite Autonomic Symptom Score-31 (COMPASS-31) [Срок оценки: 1 week, 2 weeks, 3 weeks, 4 weeks]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form
• Age equal to or >18 years old
• Stated interest in and willingness to receive VCS and to complete the online patient reported outcomes before and after the procedure.
• Owns or has access to a smart phone or computer to complete outcome measures
• Fluency in English
• Diagnosis of Fibromyalgia (FM)

• Diagnosis by American College of Rheumatology 2016 questionnaire
• Pain score 4/10 or more and less than 10/10 on the numeric rating scale at the time of inclusion.

Критерии исключения

• History of tympanic membrane injury, rupture, or surgery a. Including tympanostomy, or "ear tubes," and/or cochlear implant.
• Right ear infection within the last 3 months, or current right ear pain.
• Current pregnancy
• Bipolar Disorder
• History of seizures (including non-epileptiform seizures)
• History of syncope within the last 3 months. a. Not including presyncope or in setting of known medical illness (i.e., heatstroke)
• Inability to lay supine for 15 minutes
• Receiving disability benefits for fibromyalgia or involved in litigation related to fibromyalgia.
• Clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study.
• History of or current Meniere's Disease
• History of myocardial infarction (MI), stroke or TIA, or coronary artery bypass graft (CABG) in the last 3 months
• History of hospitalization for severe hypertension
• History of vestibular schwannoma or meningioma resection.
• Patients taking opioid therapy (not including tramadol).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mount Sinai West — New York

Идентификаторы

NCT: NCT07423377 · STUDY-25-01272

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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