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Thread Embedding Acupuncture for Temporomandibular Disorder: Protocol for a Pilot Randomized Controlled Trial
BACKGROUND: Temporomandibular disorder (TMD) affects multiple tissues of the temporomandibular joint complex and manifests as orofacial pain and functional disturbance. While thread embedding acupuncture (TEA) is used for the treatment of TMD in clinical practice, sufficient clinical evidence is lac...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9576803/ https://www.ncbi.nlm.nih.gov/pubmed/36267351 http://dx.doi.org/10.2147/JPR.S383965 |
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author | Kim, Jung-Hyun Kang, Dahae Kim, Koh-Woon Nam, Sang-Soo Goo, Bonhyuk |
author_facet | Kim, Jung-Hyun Kang, Dahae Kim, Koh-Woon Nam, Sang-Soo Goo, Bonhyuk |
author_sort | Kim, Jung-Hyun |
collection | PubMed |
description | BACKGROUND: Temporomandibular disorder (TMD) affects multiple tissues of the temporomandibular joint complex and manifests as orofacial pain and functional disturbance. While thread embedding acupuncture (TEA) is used for the treatment of TMD in clinical practice, sufficient clinical evidence is lacking. This pilot trial will explore the feasibility of a confirmatory randomized controlled trial (RCT) by considering the efficacy, safety, and cost-effectiveness of TEA to address pain, function, and quality of life in patients with TMD. METHODS: This randomized, assessor-blinded, controlled trial will include two parallel arms. Thirty patients with TMD and temporomandibular joint pain more severe than 40 mm on the 100-mm visual analog scale (VAS) and aged 19–70 years will be recruited and randomly allocated to either TEA or usual care groups. The TEA group will receive treatment at 14 predefined acupoints once weekly for 4 weeks. The usual care group will receive physical therapy consisting of transcutaneous electrical nerve stimulation and infrared therapy. The average VAS score over the last week for temporomandibular pain after four sessions will be assessed as the primary outcome. Furthermore, maximum pain VAS, vertical opening movement, Graded Chronic Pain version 2, Jaw Functional Limitation Scale 20, Patient Global Impression of Change, Korean version of Beck’s Depression Index, Short Form-12 Health Survey, EuroQol 5-Dimension 5-level, treatment expectation, rescue medication consumption, adverse events, and medical costs for economic evaluation will be measured and analyzed as secondary outcomes during four follow-up visits and after the termination of all sessions. CONCLUSION: The results of this trial will help evaluate the feasibility of a confirmatory RCT considering efficacy, safety, and cost-effectiveness and verify the effect size required to determine an appropriate sample size. TRIAL REGISTRATION NUMBER: KCT0007421. |
format | Online Article Text |
id | pubmed-9576803 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-95768032022-10-19 Thread Embedding Acupuncture for Temporomandibular Disorder: Protocol for a Pilot Randomized Controlled Trial Kim, Jung-Hyun Kang, Dahae Kim, Koh-Woon Nam, Sang-Soo Goo, Bonhyuk J Pain Res Study Protocol BACKGROUND: Temporomandibular disorder (TMD) affects multiple tissues of the temporomandibular joint complex and manifests as orofacial pain and functional disturbance. While thread embedding acupuncture (TEA) is used for the treatment of TMD in clinical practice, sufficient clinical evidence is lacking. This pilot trial will explore the feasibility of a confirmatory randomized controlled trial (RCT) by considering the efficacy, safety, and cost-effectiveness of TEA to address pain, function, and quality of life in patients with TMD. METHODS: This randomized, assessor-blinded, controlled trial will include two parallel arms. Thirty patients with TMD and temporomandibular joint pain more severe than 40 mm on the 100-mm visual analog scale (VAS) and aged 19–70 years will be recruited and randomly allocated to either TEA or usual care groups. The TEA group will receive treatment at 14 predefined acupoints once weekly for 4 weeks. The usual care group will receive physical therapy consisting of transcutaneous electrical nerve stimulation and infrared therapy. The average VAS score over the last week for temporomandibular pain after four sessions will be assessed as the primary outcome. Furthermore, maximum pain VAS, vertical opening movement, Graded Chronic Pain version 2, Jaw Functional Limitation Scale 20, Patient Global Impression of Change, Korean version of Beck’s Depression Index, Short Form-12 Health Survey, EuroQol 5-Dimension 5-level, treatment expectation, rescue medication consumption, adverse events, and medical costs for economic evaluation will be measured and analyzed as secondary outcomes during four follow-up visits and after the termination of all sessions. CONCLUSION: The results of this trial will help evaluate the feasibility of a confirmatory RCT considering efficacy, safety, and cost-effectiveness and verify the effect size required to determine an appropriate sample size. TRIAL REGISTRATION NUMBER: KCT0007421. Dove 2022-10-13 /pmc/articles/PMC9576803/ /pubmed/36267351 http://dx.doi.org/10.2147/JPR.S383965 Text en © 2022 Kim et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). |
spellingShingle | Study Protocol Kim, Jung-Hyun Kang, Dahae Kim, Koh-Woon Nam, Sang-Soo Goo, Bonhyuk Thread Embedding Acupuncture for Temporomandibular Disorder: Protocol for a Pilot Randomized Controlled Trial |
title | Thread Embedding Acupuncture for Temporomandibular Disorder: Protocol for a Pilot Randomized Controlled Trial |
title_full | Thread Embedding Acupuncture for Temporomandibular Disorder: Protocol for a Pilot Randomized Controlled Trial |
title_fullStr | Thread Embedding Acupuncture for Temporomandibular Disorder: Protocol for a Pilot Randomized Controlled Trial |
title_full_unstemmed | Thread Embedding Acupuncture for Temporomandibular Disorder: Protocol for a Pilot Randomized Controlled Trial |
title_short | Thread Embedding Acupuncture for Temporomandibular Disorder: Protocol for a Pilot Randomized Controlled Trial |
title_sort | thread embedding acupuncture for temporomandibular disorder: protocol for a pilot randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9576803/ https://www.ncbi.nlm.nih.gov/pubmed/36267351 http://dx.doi.org/10.2147/JPR.S383965 |
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