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Effectiveness of paranasal air suction on acute migraine using portable air sucker – a randomized, double blind study

BACKGROUND: Migraine is a primary headache disorder and is the most common disabling primary headache disorder that occurs in children and adolescents. A recent study showed that paranasal air suction can provide relief to migraine headache. However, in order to get the maximum benefit out of it, an...

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Autores principales: Bandara, S. M. R., Samita, S., Kiridana, A. M., Herath, H. M. M. T. B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8066867/
https://www.ncbi.nlm.nih.gov/pubmed/33892652
http://dx.doi.org/10.1186/s12883-021-02203-x
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author Bandara, S. M. R.
Samita, S.
Kiridana, A. M.
Herath, H. M. M. T. B.
author_facet Bandara, S. M. R.
Samita, S.
Kiridana, A. M.
Herath, H. M. M. T. B.
author_sort Bandara, S. M. R.
collection PubMed
description BACKGROUND: Migraine is a primary headache disorder and is the most common disabling primary headache disorder that occurs in children and adolescents. A recent study showed that paranasal air suction can provide relief to migraine headache. However, in order to get the maximum benefit out of it, an easy to use effective air sucker should be available. Aiming to fulfil the above requirement, a randomized, double blind control clinical trial was conducted to investigate the efficacy of a recently developed low–pressure portable air sucker. METHODS: Eighty-six Sri Lankan school children of age 16–19 years with migraine were enrolled for the study. They were randomly allocated into two groups, and one group was subjected to six intermittent ten-second paranasal air suctions using the portable air sucker for 120 s. The other group was subjected to placebo air suction (no paranasal air suction). The effect of suction using portable air sucker was the primary objective but side of headache, type of headache, and gender were also studied as source variables. The primary response studied was severity of headache. In addition, left and right supraorbital tenderness, photophobia, phonophobia, numbness over the face and scalp, nausea and generalized tiredness/weakness of the body were studied. The measurements on all those variables were made before and after suction, and the statistical analysis was performed based on before and after differences. As a follow–up, patients were monitored for 24-h period. RESULTS: There was a significant reduction in the severity of headache pain (OR = 25.98, P < 0.0001), which was the primary outcome variable, and other migraine symptoms studied, tenderness (left) (OR = 289.69, P < 0.0001), tenderness (right) (OR > 267.17, P < 0.0001), photophobia (OR = 2115.6, P < 0.0001), phonophobia (OR > 12.62, P < 0.0001) nausea (OR > 515.59, P < 0.0001) and weakness (OR = 549.06, P < 0.0001) except for numbness (OR = 0.747, P = 0.67) in the treatment group compared to the control group 2 min after the suction. These symptoms did not recur within 24-h period and there were no significant side effects recorded during the 24-h observation period. CONCLUSION: This pilot study showed that low–pressure portable air sucker is effective in paranasal air suction, and suction for 120 s using the sucker can provide an immediate relief which can last for more than 24-h period without any side effects. TRAIL REGISTRATION: Clinical Trial Government Identification Number – 1548/2016. Ethical Clearance Granted Institute – Medical Research Institute, Colombo, Sri Lanka (No 38/2016). Sri Lanka Clinical Trial Registration No: SLCTR/2017/018. Date of registration = 29/ 06/2017. Approval Granting Organization to use the device in the clinical trial– National Medicines Regulatory Authority Sri Lanka (16 Jan 2018), The device won award at Geneva international inventers exhibition in 2016 and President award in 2018 in Sri Lanka. It is a patented device in Sri Lanka and patent number was SLKP/1/18295. All methods were carried out in accordance with CONSORT 2010 guidelines.
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spelling pubmed-80668672021-04-26 Effectiveness of paranasal air suction on acute migraine using portable air sucker – a randomized, double blind study Bandara, S. M. R. Samita, S. Kiridana, A. M. Herath, H. M. M. T. B. BMC Neurol Research Article BACKGROUND: Migraine is a primary headache disorder and is the most common disabling primary headache disorder that occurs in children and adolescents. A recent study showed that paranasal air suction can provide relief to migraine headache. However, in order to get the maximum benefit out of it, an easy to use effective air sucker should be available. Aiming to fulfil the above requirement, a randomized, double blind control clinical trial was conducted to investigate the efficacy of a recently developed low–pressure portable air sucker. METHODS: Eighty-six Sri Lankan school children of age 16–19 years with migraine were enrolled for the study. They were randomly allocated into two groups, and one group was subjected to six intermittent ten-second paranasal air suctions using the portable air sucker for 120 s. The other group was subjected to placebo air suction (no paranasal air suction). The effect of suction using portable air sucker was the primary objective but side of headache, type of headache, and gender were also studied as source variables. The primary response studied was severity of headache. In addition, left and right supraorbital tenderness, photophobia, phonophobia, numbness over the face and scalp, nausea and generalized tiredness/weakness of the body were studied. The measurements on all those variables were made before and after suction, and the statistical analysis was performed based on before and after differences. As a follow–up, patients were monitored for 24-h period. RESULTS: There was a significant reduction in the severity of headache pain (OR = 25.98, P < 0.0001), which was the primary outcome variable, and other migraine symptoms studied, tenderness (left) (OR = 289.69, P < 0.0001), tenderness (right) (OR > 267.17, P < 0.0001), photophobia (OR = 2115.6, P < 0.0001), phonophobia (OR > 12.62, P < 0.0001) nausea (OR > 515.59, P < 0.0001) and weakness (OR = 549.06, P < 0.0001) except for numbness (OR = 0.747, P = 0.67) in the treatment group compared to the control group 2 min after the suction. These symptoms did not recur within 24-h period and there were no significant side effects recorded during the 24-h observation period. CONCLUSION: This pilot study showed that low–pressure portable air sucker is effective in paranasal air suction, and suction for 120 s using the sucker can provide an immediate relief which can last for more than 24-h period without any side effects. TRAIL REGISTRATION: Clinical Trial Government Identification Number – 1548/2016. Ethical Clearance Granted Institute – Medical Research Institute, Colombo, Sri Lanka (No 38/2016). Sri Lanka Clinical Trial Registration No: SLCTR/2017/018. Date of registration = 29/ 06/2017. Approval Granting Organization to use the device in the clinical trial– National Medicines Regulatory Authority Sri Lanka (16 Jan 2018), The device won award at Geneva international inventers exhibition in 2016 and President award in 2018 in Sri Lanka. It is a patented device in Sri Lanka and patent number was SLKP/1/18295. All methods were carried out in accordance with CONSORT 2010 guidelines. BioMed Central 2021-04-24 /pmc/articles/PMC8066867/ /pubmed/33892652 http://dx.doi.org/10.1186/s12883-021-02203-x Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Bandara, S. M. R.
Samita, S.
Kiridana, A. M.
Herath, H. M. M. T. B.
Effectiveness of paranasal air suction on acute migraine using portable air sucker – a randomized, double blind study
title Effectiveness of paranasal air suction on acute migraine using portable air sucker – a randomized, double blind study
title_full Effectiveness of paranasal air suction on acute migraine using portable air sucker – a randomized, double blind study
title_fullStr Effectiveness of paranasal air suction on acute migraine using portable air sucker – a randomized, double blind study
title_full_unstemmed Effectiveness of paranasal air suction on acute migraine using portable air sucker – a randomized, double blind study
title_short Effectiveness of paranasal air suction on acute migraine using portable air sucker – a randomized, double blind study
title_sort effectiveness of paranasal air suction on acute migraine using portable air sucker – a randomized, double blind study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8066867/
https://www.ncbi.nlm.nih.gov/pubmed/33892652
http://dx.doi.org/10.1186/s12883-021-02203-x
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