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Completed

NCT Number: NCT05004194

Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vestibular Caloric Stimulation

Procedure

Irrigation of the right external ear canal

Other names: VCS, Cold water caloric stimulation

Primary outcomes

  1. Change in Numeric Rating Scale (NRS)

    Time frame: 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.

Secondary outcomes

  1. Acute change in NRS

    Time frame: 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.

  2. Percentage of participants with NRS pain scores >= to 30% and 50%

    Time frame: 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%.

  3. Patient Global Impression of Change (PGIC)

    Time frame: at 1 weeks, 2 weeks and 4 weeks after VCS

    Full score from 0-7, with higher score indicating more improvement.

  4. Change in Multidimensional Assessment of Fatigue (MAF)

    Time frame: 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.

  5. Michigan Neuropathy Screening Instrument (MNSI)

    Time frame: 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.

  6. Change in Brief Pain Inventory Short Form 36 (BPI SF36)

    Time frame: 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.

  7. Change in Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: 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.

  8. Change in Numeric Rating Scale (NRS) for pain in different regions of the body

    Time frame: 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.

  9. VCS Tolerability Survey

    Time frame: 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.

  10. Number of participants willing to trial VCS again

    Time frame: 24 hours post VCS

    Number of participants expressing willingness to trial VCS again

  11. Change in Subjective Overall Well Being Scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia: An Open Label Pilot Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2021
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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