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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vestibulocortical Stimulation | Experimental | Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second. |
|
| Sham Stimulation | Sham Comparator | Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vestibulocortical Stimulation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain numeric rating scale (NRS) | 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. | Baseline and 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain numeric rating scale (NRS) | 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. | 30 minutes, 24 hours, 2 weeks, 3 weeks, 4 weeks |
| Overall Well Being Scale |
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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)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Talia Torkian | Contact | 212-241-1671 | viptrial@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Michael Kaplan, MD | Mount Sinai Hospital, Icahn School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai West | Recruiting | New York | New York | 10019 | United States |
Deidentified individual participant data will not be made available because participants did not provide consent for data sharing beyond the scope of the present study. Aggregate data supporting the findings are included in the article.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D000098653 | Nociplastic Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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Randomized controlled trial
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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.
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Numeric rating scale scored from 0-10, 0 = lowest quality of life, 10 = best imaginable. Higher score indicates better health outcomes. |
| 30 minutes |
| Patient Global Impression of Change (PGIC) | 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. | 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Brief Pain Inventory (Short-Form; BPI-SF) | 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. | 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Patient Reported Outcomes Measurement Information System (PROMIS-29) | 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. | 1 week, 2 weeks, 3 weeks, 4 weeks |
| Composite Autonomic Symptom Score-31 (COMPASS-31) | 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. | 1 week, 2 weeks, 3 weeks, 4 weeks |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |