Vestibular Innovation in Pain 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Vestibulocortical Stimulation
Procedure/SurgeryVCS 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.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Vestibulocortical StimulationExperimental treatment 1 intervention
Group B: Sham StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 1 weekSecondary outcomes
1
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.
Time frame
30 minutes, 24 hours, 2 weeks, 3 weeks, 4 weeks2
Overall Well Being Scale
Numeric rating scale scored from 0-10, 0 = lowest quality of life, 10 = best imaginable. Higher score indicates better health outcomes.
Time frame
30 minutes3
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.
Time frame
24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks4
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.
Time frame
24 hours, 1 week, 2 weeks, 3 weeks, 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov