Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion

Abstract

Abstract Background Inflammation and swelling of the sinus and nasal mucosa are commonly caused by viral infection, bacterial infection, or exposure to allergens and irritants. Sinonasal inflammation can cause symptoms of nasal congestion, facial pressure, and rhinogenic facial pain or “sinus pain”. A previous randomized controlled study demonstrated that acute treatment with non-invasive periorbital microcurrent stimulation resulted in a rapid and clinically meaningful reduction in self-report of sinus pain that significantly outperformed sham control treatment. Here, we assessed the acute durability of microcurrent pain relief and longitudinal effects of 4 weeks of daily microcurrent treatment in patients presenting with sinus pain. Methods Thirty subjects with moderate facial pain (numeric rating scale ≥5) attributed to self-reported sinonasal disease were enrolled in a single-arm, prospective interventional study. At enrollment, subjects were given a microcurrent treatment device and written instructions and self-administered the device to the bilateral periorbital regions for 5 mins. Subjects were instructed to treat themselves at home once daily and up to four times daily as needed for 4 weeks. Pain was measured both acutely and weekly during the 4 weeks of treatment using the numeric rating scale. Congestion and medication use data were collected weekly using the Congestion Quantifier 7 (CQ7) and medication diary, respectively. Results Thirty patients were enrolled and completed the study. Microcurrent therapy rapidly reduced post-treatment numeric rating scale for pain by − 1.2 at 10 mins (p = 0.0076), − 1.6 at 1 hr (p = 0.0007), − 1.9 at 2 hrs (p < 0.0001), − 2.1 at 4 hrs (p < 0.0001), and − 2.1 at 6 hrs (p < 0.0001). With daily microcurrent treatment, numeric rating scale for pain was reduced over 4 weeks by − 1.3 (− 20.1%) after 1 week (p = 0.0018), − 2.1 (− 32.1%) after 2 weeks (p < 0.0001), − 2.4 (− 36.6%) after 3 weeks (p < 0.0001) and − 2.9 (− 43.3%) after 4 weeks (p < 0.0001). For subjects who enrolled with moderate or worse congestion, mean congestion scores (CQ7) were reduced by − 4.2 (− 22.0%) after 1 week (p < 0.0001), − 5.8 (− 33.0%) after 2 weeks (p < 0.0001), − 7.2 (− 37.4%) after 3 weeks (p < 0.0001) and − 8.6 (− 44.3%) after 4 weeks (p < 0.0001) of microcurrent treatment. Conclusion Self-administered periorbital microcurrent treatment given at home was efficacious in significantly reducing moderate sinus pain for up to 6 hrs and significantly reducing moderate pain and congestion over 4 weeks of daily use. Microcurrent therapy was found to be safe with only minor side effects that resolved without intervention. Trial registration ClinicalTrials.gov, NCT03888274. Registered 25 March 2019. Retroactively registered, https://clinicaltrials.gov/ct2/show/NCT03888274.