Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia: An Open Label Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Numeric Rating Scale (NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Cold water caloric stimulation
50 cc of ice-cold water irrigation into the right ear at 1-2 cc/second, once per participant.
干预措施: Vestibular Caloric Stimulation (Procedure)
结局指标
主要结局
Change in Numeric Rating Scale (NRS)
时间窗: 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.
次要结局
- Acute change in NRS(baseline and 5, 15 and 30 minutes after VCS)
- Percentage of participants with NRS pain scores >= to 30% and 50%(30 minutes, 24 hours, 1 week, 2 weeks after VCS)
- Patient Global Impression of Change (PGIC)(at 1 weeks, 2 weeks and 4 weeks after VCS)
- Change in Multidimensional Assessment of Fatigue (MAF)(baseline and at 1, 2 and 4 weeks after VCS)
- Michigan Neuropathy Screening Instrument (MNSI)(baseline and at 1, 2 and 4 weeks after VCS)
- Change in Brief Pain Inventory Short Form 36 (BPI SF36)(baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS)
- Change in Fibromyalgia Impact Questionnaire (FIQ)(baseline and at 1, 2 and 4 weeks after VCS)
- Change in Numeric Rating Scale (NRS) for pain in different regions of the body(baseline and at 24 hours, 1 week, 2 week, 4 week after VCS)
- VCS Tolerability Survey(24 hours post VCS)
- Number of participants willing to trial VCS again(24 hours post VCS)
- Change in Subjective Overall Well Being Scale(at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative)
研究者
Ioannis Tassiulas
Associate Professor of Medicine, Rheumatology
Icahn School of Medicine at Mount Sinai