Microcurrent technology for rapid relief of sinus pain: a randomized, placebo-controlled, double-blinded clinical trial.

Abstract

BackgroundTranscutaneous 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 short‐term, office‐based treatment of patients with sinus pain. This device, which is U.S. Food and Drug Administration (FDA)‐cleared, detects and treats regions corresponding to nerve fibers.MethodsRandomized, double‐blinded, placebo‐controlled trial. Seventy‐one participants with facial pain attributed to self‐reported nasal/sinus disease were recruited from a tertiary rhinologic practice and the surrounding community and randomly assigned to either office‐based use of an active (n = 38) or placebo (n = 33) microcurrent emitter. The study device was repetitively applied by each patient to the bilateral periorbital areas for 5 minutes. A visual analogue scale (VAS) for pain severity was administered before, and 10 minutes after, treatment.ResultsActive microcurrent‐treated patients had a reduction in mean pain score from 5.63 pretreatment to 3.97 posttreatment (mean difference, 1.66; 95% confidence interval [CI], 1.20 to 2.12). Patients using the sham device also reported sinus pain reductions (mean difference, 0.91; 95% CI, 0.61 to 1.21). However, the active device demonstrated a significantly greater reduction in pain compared to sham (0.75‐point difference, p = 0.007). Notably, 23.7% of patients using the active device had a reduction of 3 or more points by VAS compared to 0% of sham device patients (p = 0.003). One minor occurrence of transient facial skin erythema was noted.ConclusionThis trial suggests that treatment of rhinologic facial pain using this noninvasive microcurrent device is safe and effective in providing rapid relief of nasal/sinus pain. Additional studies with longer term follow‐up are warranted.