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

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 previ...

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Autores principales: Goldsobel, Alan B., Prabhakar, Niveditha, Gurfein, Blake T.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7098235/
https://www.ncbi.nlm.nih.gov/pubmed/32232107
http://dx.doi.org/10.1186/s42234-019-0035-x
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author Goldsobel, Alan B.
Prabhakar, Niveditha
Gurfein, Blake T.
author_facet Goldsobel, Alan B.
Prabhakar, Niveditha
Gurfein, Blake T.
author_sort Goldsobel, Alan B.
collection PubMed
description 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.
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spelling pubmed-70982352020-03-30 Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion Goldsobel, Alan B. Prabhakar, Niveditha Gurfein, Blake T. Bioelectron Med Research Article 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. BioMed Central 2019-11-20 /pmc/articles/PMC7098235/ /pubmed/32232107 http://dx.doi.org/10.1186/s42234-019-0035-x Text en © The Author(s) 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Goldsobel, Alan B.
Prabhakar, Niveditha
Gurfein, Blake T.
Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion
title Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion
title_full Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion
title_fullStr Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion
title_full_unstemmed Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion
title_short Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion
title_sort prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7098235/
https://www.ncbi.nlm.nih.gov/pubmed/32232107
http://dx.doi.org/10.1186/s42234-019-0035-x
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