search
Back to results

Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vestibular Caloric Stimulation
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cold water caloric stimulation

Arm Description

50 cc of ice-cold water irrigation into the right ear at 1-2 cc/second, once per participant.

Outcomes

Primary Outcome Measures

Change in Numeric Rating Scale (NRS)
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 Outcome Measures

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

Full Information

First Posted
August 9, 2021
Last Updated
August 12, 2021
Sponsor
Icahn School of Medicine at Mount Sinai
search

1. Study Identification

Unique Protocol Identification Number
NCT05004194
Brief Title
Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia
Official Title
Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia: An Open Label Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
July 2, 2021 (Actual)
Study Completion Date
July 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
An open label non-randomized pilot trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cold water caloric stimulation
Arm Type
Experimental
Arm Description
50 cc of ice-cold water irrigation into the right ear at 1-2 cc/second, once per participant.
Intervention Type
Procedure
Intervention Name(s)
Vestibular Caloric Stimulation
Other Intervention Name(s)
VCS, Cold water caloric stimulation
Intervention Description
Irrigation of the right external ear canal
Primary Outcome Measure Information:
Title
Change in Numeric Rating Scale (NRS)
Description
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.
Time Frame
baseline and 1 week after VCS
Secondary Outcome Measure Information:
Title
Acute change in NRS
Description
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.
Time Frame
baseline and 5, 15 and 30 minutes after VCS
Title
Percentage of participants with NRS pain scores >= to 30% and 50%
Description
Percentage of patients with change in pain assessed by NRS pain scores > or equal to 30% and 50%.
Time Frame
30 minutes, 24 hours, 1 week, 2 weeks after VCS
Title
Patient Global Impression of Change (PGIC)
Description
Full score from 0-7, with higher score indicating more improvement.
Time Frame
at 1 weeks, 2 weeks and 4 weeks after VCS
Title
Change in Multidimensional Assessment of Fatigue (MAF)
Description
MAF is a 16 item instrument, full scale from 0-50, with higher score indicating more fatigue.
Time Frame
baseline and at 1, 2 and 4 weeks after VCS
Title
Michigan Neuropathy Screening Instrument (MNSI)
Description
15 "yes or no" questions - full score from 0-13, with higher score indicating more neuropathic symptoms.
Time Frame
baseline and at 1, 2 and 4 weeks after VCS
Title
Change in Brief Pain Inventory Short Form 36 (BPI SF36)
Description
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.
Time Frame
baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
Title
Change in Fibromyalgia Impact Questionnaire (FIQ)
Description
Full scale from 0-100, with higher score indicating a greater impact of fibromyalgia syndrome.
Time Frame
baseline and at 1, 2 and 4 weeks after VCS
Title
Change in Numeric Rating Scale (NRS) for pain in different regions of the body
Description
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.
Time Frame
baseline and at 24 hours, 1 week, 2 week, 4 week after VCS
Title
VCS Tolerability Survey
Description
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.
Time Frame
24 hours post VCS
Title
Number of participants willing to trial VCS again
Description
Number of participants expressing willingness to trial VCS again
Time Frame
24 hours post VCS
Title
Change in Subjective Overall Well Being Scale
Description
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
Time Frame
at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioannis Tassiulas, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia

We'll reach out to this number within 24 hrs