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.

Keywords: Allergic rhinitis; Congestion; Cranial nerve; Facial pain; Microcurrent; Nasal congestion; Rhinologic facial pain; Sinus pain; Transcutaneous electrical nerve stimulation; Trigeminal nerve.

Fig. 1

Microcurrent device and treatment path. The microcurrent device used in this study has a stimulation electrode at the tip and a return electrode built into the housing, comprising a monopolar design (a). Subjects were instructed to self-administer the device and follow a treatment path around the bilateral periorbital areas along the cheek, nose, and brow ridge (b). Subcutaneous fibers of trigeminal nerve branches V₁ (ophthalmic nerve) and V₂ (maxillary nerve) are targets of microcurrent stimulation (c)

Fig. 2

Microcurrent treatment rapidly reduces sinus pain for up to 6 h. Thirty subjects with sinus pain self-administered microcurrent treatment to the bilateral periorbital areas for 5 mins and numeric rating scale for pain scores were recorded before and after treatment. Mean numeric rating scale scores were significantly reduced from 6.5 at pretreatment to 4.3 at 6 h post-treatment (a). Mean difference in pain score from before treatment peaked at − 2.1 numeric rating scale points at 4 hrs (b). Data represented as mean ± SEM. **p < 0.01, ***p < 0.001, ****p < 0.0001, repeated measures one-way ANOVA with Dunnett correction for multiple comparisons

Fig. 3

Daily microcurrent treatment reduces current sinus pain score over 4 weeks. Subjects with sinus pain self-administered microcurrent treatment at home once per day and up to four times per day as needed for 4 weeks. Numeric rating scale for pain was collected weekly. Compared to before treatment, mean current numeric rating scale for pain scores were significantly reduced at all time points measured (a). Mean difference in current pain score from before treatment peaked at − 2.9 (− 43.3%) numeric rating scale points at week four (b). Data represented as mean ± SEM. **p < 0.01, ****p < 0.0001, repeated measures one-way ANOVA with Dunnett correction for multiple comparisons

Fig. 4

Daily microcurrent treatment reduces sinonasal congestion over 4 weeks. Sinonasal congestion was assessed weekly using the Congestion Quanitfier 7 (CQ7) instrument. Subjects that enrolled with moderate or worse congestion (CQ7 > 15, N = 25) exhibited significant reductions in congestion symptoms, compared to pretreatment, at all time points measured (a). Mean difference in CQ7 score from before treatment peaked at − 8.6 (− 44.3%) points at week four (b). Data represented as mean ± SEM. ****p < 0.0001, paired, two-sided t-test

Fig. 5

Concurrent medication use during 4 weeks of microcurrent treatment. At enrollment and weeks one through four of treatment, subjects completed a medication diary detailing the classes of medication they used in the previous week including: pain, nasal decongestant spray, nasal steroid spray, decongestant in pill form, antihistamine, or prescription antibiotics. A modest trend towards decreased reliance on medication was observed from enrollment to week four, however these results were not statistically significant. Data represented as percentage of subjects on one or more medications. Chi-square test for trend