Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia
2021년 8월 12일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
21
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New York
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New York, New York, 미국, 10029
- Icahn School of Medicine at Mount Sinai
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Cold water caloric stimulation
50 cc of ice-cold water irrigation into the right ear at 1-2 cc/second, once per participant.
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Irrigation of the right external ear canal
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Numeric Rating Scale (NRS)
기간: baseline and 1 week after VCS
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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.
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baseline and 1 week after VCS
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Acute change in NRS
기간: baseline and 5, 15 and 30 minutes after VCS
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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.
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baseline and 5, 15 and 30 minutes after VCS
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Percentage of participants with NRS pain scores >= to 30% and 50%
기간: 30 minutes, 24 hours, 1 week, 2 weeks after VCS
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Percentage of patients with change in pain assessed by NRS pain scores > or equal to 30% and 50%.
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30 minutes, 24 hours, 1 week, 2 weeks after VCS
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Patient Global Impression of Change (PGIC)
기간: at 1 weeks, 2 weeks and 4 weeks after VCS
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Full score from 0-7, with higher score indicating more improvement.
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at 1 weeks, 2 weeks and 4 weeks after VCS
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Change in Multidimensional Assessment of Fatigue (MAF)
기간: baseline and at 1, 2 and 4 weeks after VCS
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MAF is a 16 item instrument, full scale from 0-50, with higher score indicating more fatigue.
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baseline and at 1, 2 and 4 weeks after VCS
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Michigan Neuropathy Screening Instrument (MNSI)
기간: baseline and at 1, 2 and 4 weeks after VCS
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15 "yes or no" questions - full score from 0-13, with higher score indicating more neuropathic symptoms.
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baseline and at 1, 2 and 4 weeks after VCS
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Change in Brief Pain Inventory Short Form 36 (BPI SF36)
기간: baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
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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.
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baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
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Change in Fibromyalgia Impact Questionnaire (FIQ)
기간: baseline and at 1, 2 and 4 weeks after VCS
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Full scale from 0-100, with higher score indicating a greater impact of fibromyalgia syndrome.
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baseline and at 1, 2 and 4 weeks after VCS
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Change in Numeric Rating Scale (NRS) for pain in different regions of the body
기간: baseline and at 24 hours, 1 week, 2 week, 4 week after VCS
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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.
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baseline and at 24 hours, 1 week, 2 week, 4 week after VCS
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VCS Tolerability Survey
기간: 24 hours post VCS
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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.
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24 hours post VCS
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Number of participants willing to trial VCS again
기간: 24 hours post VCS
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Number of participants expressing willingness to trial VCS again
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24 hours post VCS
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Change in Subjective Overall Well Being Scale
기간: at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative
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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
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at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ioannis Tassiulas, MD, Icahn School of Medicine at Mount Sinai
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 3월 19일
기본 완료 (실제)
2021년 7월 2일
연구 완료 (실제)
2021년 7월 2일
연구 등록 날짜
최초 제출
2021년 8월 9일
QC 기준을 충족하는 최초 제출
2021년 8월 9일
처음 게시됨 (실제)
2021년 8월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 8월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 8월 12일
마지막으로 확인됨
2021년 8월 1일
추가 정보
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