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

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.

Understanding the effect of pulse width on activation depth in TENS: A computational study

“…The copyright holder for this preprint this version posted April 15, 2024. ; https://doi.org/10.1101/2024.04. 10.24305618 doi: medRxiv preprint NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.…”

“…As there was no motivation for device manufacturers to develop proper clinical utility and generate high quality efficacy data, clinical evidence has continued to be debated [3,4]. Newer indications such as TENS for migraine and sinus pain have however demonstrated definitive clinical utility [9][10][11]. TENS devices are considered medium risk (Class 2) devices and are available for both prescription and OTC use.…”

Physiological effects of microcurrent and its application for maximising acute responses and chronic adaptations to exercise

“…Furthermore, no serious adverse events requiring medical treatment were reported. In a trial examining the safety and efficacy of MCT for sinus pain and congestion, it was concluded that MCT is safe with only minor side effects (tingling in the feet), which were resolved without medical intervention (Goldsobel et al 2019 ). MCT has been applied in many medical scenarios, being reported as a safe therapy over the decades (Al-Tubaikh 2018 ; Xu et al 2021 ).…”

“…Microcurrent therapy has an unrealised potential in healing dysfunctional tissue because of its ability to mimic weak, natural bioelectric ‘injury currents’, and subsequently enhance wound repairing (Poltawski and Watson 2009 ). In addition, within the clinical setting MCT has been widely applied in patients to reduce and relieve sinus pain (Goldsobel et al 2019 ; Maul et al 2019 ), chronic scar pain and itch from skin scars (Perry et al 2010 ; Ud-Din et al 2013 ), chronic back pain (Lerner and Kirsch 1981 ), and partial rotator cuff tears related pain (Vrouva et al 2019 ).…”

Bioelectric Effect of a Microcurrent Toothbrush on Plaque Removal

“…Microcurrents below 100 µA are harmless to the human body [22,23]. PB has been approved by the FDA, US Federal Communications Commission, Korea Certification mark (Korea), Conformite European mark (Europe), Product Safety Electrical mark (Japan) as safe.…”