Abstract
BackgroundInflammation 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.MethodsThirty 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.ResultsThirty 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.ConclusionSelf-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 registrationClinicalTrials.gov, NCT03888274. Registered 25 March 2019. Retroactively registered, https://clinicaltrials.gov/ct2/show/NCT03888274.
Highlights
Inflammation of the sinuses and nasal mucosa results in symptoms such as thick nasal mucus, tissue swelling, nasal congestion or obstruction, and pain and pressure in the face (Rosenfeld et al 2015; Seidman et al 2015)
The study results demonstrated that bioelectronic microcurrent treatment rapidly induced a clinically meaningful reduction in sinus pain (− 29.6%) that was significantly greater than the pain reduction observed in sham-treated patients
Microcurrent treatment rapidly reduces sinus pain for up to 6 h In this study, thirty patients presenting with rhinologic facial pain (“sinus pain”) were recruited from a tertiary allergy clinic
Summary
Inflammation of the sinuses and nasal mucosa results in symptoms such as thick nasal mucus, tissue swelling, nasal congestion or obstruction, and pain and pressure in the face (Rosenfeld et al 2015; Seidman et al 2015). Rhinosinusitis and allergic rhinitis are the commonest causes of sinonasal inflammation and impact approximately 12% and 30% of the population, respectively (Blackwell et al 2015; Meltzer and Bukstein 2011; Salo et al 2011). 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”. 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
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