Vestibular Innovation in Pain: An Open Label Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in Diary pain numeric rating scale (Pain NRS) scores
研究概览
简要总结
The VIP trial will assess the effectiveness, tolerability, and durability of effect of vestibulocortical stimulation (VCS) - a safe & cost-effective bedside technique - in treating pain, fatigue & related symptoms using validated patient-reported outcomes. Data from this trial will be used to guide optimized treatment protocols in future randomized controlled trials and help inform the implementation of VCS into standard clinical practice.
详细描述
VCS is a form of non-invasive neuromodulation whereby cold water is irrigated into the external ear canal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Diagnosis of one of the following:
- •Fibromyalgia (FM), with at least a 4/10 average baseline pain on the numeric rating scale at the time of inclusion.
- •Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
- •Long-COVID
- •Post Treatment Lyme Disease Syndrome (PTLDS)
排除标准
- •An individual with any of the following criteria will be excluded from participation in this study:
- •History of tympanic membrane injury, rupture, or surgery
- •Including tympanostomy, or "ear tubes," and/or cochlear implant.
- •Ear infection within the last 3 months, or current ear pain.
- •Current pregnancy
- •Bipolar Disorder
- •History of seizures (including non-epileptiform seizures)
- •History of syncope
- •Inability to lay supine for 30 minutes
- •Clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study
- •Not fluent in English
- •History of or current Meniere's Disease
- •History of myocardial infarction (MI), stroke or TIA, or coronary artery bypass graft (CABG) in the last three months
- •History of hospitalization for severe hypertension
- •History of vestibular schwannoma or meningioma resection.
结局指标
主要结局
Change in Diary pain numeric rating scale (Pain NRS) scores
时间窗: Baseline and at 1 week after VCS
Change in diary pain scores on a 11 point numeric rating scale at 1 week after VCS as compared to baseline. Full scale from 0-10, with higher score indicating worse pain.
次要结局
- Acute and Longitudinal Change in numeric rating scale (Pain NRS)(Baseline and at 30 minutes, 24 hours, 2 weeks, and 4 weeks)
- Percentage of Patients with Numeric Rating Scale (NRS) pain scores > = to 30% and 50%(30 minutes, 24 hours, 1 week, 2 weeks, 4 weeks)
- Brief Pain Inventory- Short Form(24 hours)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score(1 week, 2 weeks, 4 weeks)
- Overall Well Being Numeric Rating Scale (NRS)(at 30 minutes)
- VCS Tolerability Survey(24 hours post VCS)
- Patient Global Impression of Change (PGIC) Score(24 hours, 1 week, 2 week, 4 weeks)
- Fatigue Severity Scale (FSS) Score(1 weeks, 2 weeks, 4 weeks)
- Epworth Sleepiness Scale (ESS) Score(1 weeks, 2 weeks, 4 weeks)
- Compass-31 Score(1 weeks, 2 weeks, 4 weeks)
研究者
Michael H Kaplan
Assistant Professor of Medicine
Icahn School of Medicine at Mount Sinai