Fibromyalgia, Nociplastic Pain
Conditions
Keywords
pain, quality of life
Brief summary
Fibromyalgia is the most common centralized pain disorder, affecting up to 3% of the population. Current treatments are incompletely effective, often poorly tolerated, and costly: there remains an urgent need for novel, effective, and well-tolerated therapy. Preliminary data suggests that vestibulocortical stimulation (VCS), or irrigating the external ear canal with temperate water, could rapidly improve pain and quality of life in this cohort. The VIPR trial will assess the efficacy of a single session of VCS - a safe & cost-effective bedside technique using a plastic syringe and temperate water - relative to sham in treating pain & improving quality of life using validated patient-reported outcomes.
Interventions
PROCEDUREVestibulocortical Stimulation
VCS is a non-invasive bedside procedure using temperate water, and a plastic syringe (no needles). With the participant laying supine, temperate water is irrigated into the external ear canal at 1-2 cc/second.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
A blind-to-hypothesis approach will be used. Investigators and participants will not be blinded to temperature of water as the procedure itself does not lend to it.
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form * Age equal to or \>18 years old * Stated interest in and willingness to receive VCS and to complete the online patient reported outcomes before and after the procedure. * Owns or has access to a smart phone or computer to complete outcome measures * Fluency in English * Diagnosis of Fibromyalgia (FM) * Diagnosis by American College of Rheumatology 2016 questionnaire * Pain score 4/10 or more and less than 10/10 on the numeric rating scale at the time of inclusion.
Exclusion criteria
* History of tympanic membrane injury, rupture, or surgery a. Including tympanostomy, or "ear tubes," and/or cochlear implant. * Right ear infection within the last 3 months, or current right ear pain. * Current pregnancy * Bipolar Disorder * History of seizures (including non-epileptiform seizures) * History of syncope within the last 3 months. a. Not including presyncope or in setting of known medical illness (i.e., heatstroke) * Inability to lay supine for 15 minutes * Receiving disability benefits for fibromyalgia or involved in litigation related to fibromyalgia. * Clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study. * History of or current Meniere's Disease * History of myocardial infarction (MI), stroke or TIA, or coronary artery bypass graft (CABG) in the last 3 months * History of hospitalization for severe hypertension * History of vestibular schwannoma or meningioma resection. * Patients taking opioid therapy (not including tramadol).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain numeric rating scale (NRS) | Baseline and 1 week | Change in NRS as compared to baseline. Pain numeric rating scale (NRS), Full score on scale from 0-10 (0 = no pain; 10 = pain as bad as you can imagine). Higher scores indicate more pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain numeric rating scale (NRS) | 30 minutes, 24 hours, 2 weeks, 3 weeks, 4 weeks | Change in Pain numeric rating scale (NRS) (acute and long term). Pain numeric rating scale (NRS), Full score on scale from 0-10. 0 = no pain; 10 = pain as bad as you can imagine. Higher scores indicate more pain. |
| Overall Well Being Scale | 30 minutes | Numeric rating scale scored from 0-10, 0 = lowest quality of life, 10 = best imaginable. Higher score indicates better health outcomes. |
| Patient Global Impression of Change (PGIC) | 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks | Full scale scored from 0-7 scale. 0 = No change or condition has worsened; 7 = A great deal better with considerable improvement. Higher score indicates better health outcomes. |
| Brief Pain Inventory (Short-Form; BPI-SF) | 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks | Validated patient reported outcome that measures both pain intensity and pain interference. The BPI-SF uses numeric rating scales (0-10) to evaluate worst, least, average, and current pain intensity, as well as pain interference with general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Pain intensity, Subscale scored from 0-10 NRS: 0 = no pain, 10 = worst pain imaginable. Pain interference, Subscale scored from 0-10 NRS: 0= Does not interfere, 10 = Completely interferes. |
| Patient Reported Outcomes Measurement Information System (PROMIS-29) | 1 week, 2 weeks, 3 weeks, 4 weeks | PROMIS-29 includes 29 items covering seven health domains-physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain interference-each measured with four items, plus a separate 0-10 numeric rating scale for pain intensity. Each health domain is assessed with questions on a 1-5 scale, with the valence of 1 and 5 being dependent on the domain being assessed. PROMIS-29 domains are scored using T-scores, standardized to a mean of 50 and a standard deviation of 10 based on the U.S. general population. Higher scores indicate more of the concept being measured. However, whether a higher score reflects better or worse health depends on the domain. |
| Composite Autonomic Symptom Score-31 (COMPASS-31) | 1 week, 2 weeks, 3 weeks, 4 weeks | COMPASS-31 quantifies symptoms of autonomic dysfunction across six weighted domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor functions. The 31 items yield a total score ranging from 0 to 100, with higher scores indicating greater severity of autonomic symptoms. |
Countries
United States
Contacts
CONTACTTalia Torkian
PRINCIPAL_INVESTIGATORMichael Kaplan, MD
Mount Sinai Hospital, Icahn School of Medicine
Outcome results
None listed