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Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia

2021年8月12日 更新者: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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

介入性

注册 (实际的)

21

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10029
        • Icahn School of Medicine at Mount Sinai

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

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)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Cold water caloric stimulation
50 cc of ice-cold water irrigation into the right ear at 1-2 cc/second, once per participant.
Irrigation of the right external ear canal
其他名称:
  • 风控系统
  • Cold water caloric stimulation

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Numeric Rating Scale (NRS)
大体时间: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.
baseline and 1 week after VCS

次要结果测量

结果测量
措施说明
大体时间
Acute change in NRS
大体时间:baseline and 5, 15 and 30 minutes after VCS
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.
baseline and 5, 15 and 30 minutes after VCS
Percentage of participants with NRS pain scores >= to 30% and 50%
大体时间:30 minutes, 24 hours, 1 week, 2 weeks after VCS
Percentage of patients with change in pain assessed by NRS pain scores > or equal to 30% and 50%.
30 minutes, 24 hours, 1 week, 2 weeks after VCS
Patient Global Impression of Change (PGIC)
大体时间:at 1 weeks, 2 weeks and 4 weeks after VCS
Full score from 0-7, with higher score indicating more improvement.
at 1 weeks, 2 weeks and 4 weeks after VCS
Change in Multidimensional Assessment of Fatigue (MAF)
大体时间:baseline and at 1, 2 and 4 weeks after VCS
MAF is a 16 item instrument, full scale from 0-50, with higher score indicating more fatigue.
baseline and at 1, 2 and 4 weeks after VCS
Michigan Neuropathy Screening Instrument (MNSI)
大体时间:baseline and at 1, 2 and 4 weeks after VCS
15 "yes or no" questions - full score from 0-13, with higher score indicating more neuropathic symptoms.
baseline and at 1, 2 and 4 weeks after VCS
Change in Brief Pain Inventory Short Form 36 (BPI SF36)
大体时间:baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
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.
baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
Change in Fibromyalgia Impact Questionnaire (FIQ)
大体时间:baseline and at 1, 2 and 4 weeks after VCS
Full scale from 0-100, with higher score indicating a greater impact of fibromyalgia syndrome.
baseline and at 1, 2 and 4 weeks after VCS
Change in Numeric Rating Scale (NRS) for pain in different regions of the body
大体时间:baseline and at 24 hours, 1 week, 2 week, 4 week after VCS
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.
baseline and at 24 hours, 1 week, 2 week, 4 week after VCS
VCS Tolerability Survey
大体时间:24 hours post VCS
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.
24 hours post VCS
Number of participants willing to trial VCS again
大体时间:24 hours post VCS
Number of participants expressing willingness to trial VCS again
24 hours post VCS
Change in Subjective Overall Well Being Scale
大体时间:at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative
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
at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ioannis Tassiulas, MD、Icahn School of Medicine at Mount Sinai

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月19日

初级完成 (实际的)

2021年7月2日

研究完成 (实际的)

2021年7月2日

研究注册日期

首次提交

2021年8月9日

首先提交符合 QC 标准的

2021年8月9日

首次发布 (实际的)

2021年8月13日

研究记录更新

最后更新发布 (实际的)

2021年8月19日

上次提交的符合 QC 标准的更新

2021年8月12日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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Vestibular Caloric Stimulation的临床试验

3
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