Microcurrent technology for rapid relief of sinus pain: A randomized, placebo controlled, double-blinded clinical trial.
Ximena A. Maul, MD1,2, Nicole A. Borchard1, Peter H. Hwang, MD1, *, Jayakar V. Nayak, MD, PhD1
1Division of Rhinology, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, CA; 2Department of Otolaryngology, Pontificia Universidad Católica of Chile School of Medicine, Santiago, Chile.
*Is a member of the SAB of the sponsor
Tivic Health Systems, Inc. sponsored this clinical trial
Introduction: Transcutaneous electrical nerve stimulation has proven to be effective in alleviating chronic pain from facial myalgias. We evaluated the efficacy of a novel, handheld microcurrent-emitting device in the short-term, office-based treatment of patients with complaints of sinus pain.
Methods: Seventy-one participants with facial pain related to self-reported nasal/sinus disease were recruited from a tertiary rhinologic practice and the surrounding community and randomly assigned to office-based use of an active (n=38) or sham (n=33) handheld microcurrent emitter. The study device (not yet FDA-cleared), which automatically activates in regions corresponding to nerve fibers, was repetitively applied by the patient to the bilateral periorbital areas for five minutes. Visual analogue scale for pain was collected before, and 10 minutes after, treatment.
Results: Active microcurrent-treated patients had a mean pain score reduction from 5.63 pre-treatment to 3.97 post-treatment (mean difference, 1.66; CI95, 1.20-2.12). Patients using the sham device also reported sinus pain reductions representing placebo effect (mean difference, 0.91; CI95, 0.61-1.21). However, the active device demonstrated a significantly greater reduction in pain compared to sham (0.75 point difference, p=0.007). Notably, 22.5% of patients using the active device had a reduction of 3 points or more compared to 0% of sham device patients (p=0.003). One minor complication of transient facial skin erythema was noted.
Conclusion: This randomized, double-blinded, placebo-controlled trial suggests that treatment of rhinologic facial pain using this non-invasive microcurrent device is safe and effective in providing rapid relief of nasal/sinus pain complaints. Additional studies with longer term follow-up are warranted.