Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia
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.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in Numeric Rating Scale (NRS)
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Acute change in NRS
時間枠: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%
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
捜査官
- 主任研究者:Ioannis Tassiulas, MD、Icahn School of Medicine at Mount Sinai
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Vestibular Caloric Stimulationの臨床試験
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