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Efficacy of Naprapathy in Brachial Plexus Injury: Protocol for a Randomized Clinical Trial

BACKGROUND: Clinical rehabilitation for brachial plexus injury is difficult in terms of chronic pain and dysfunction. Physiotherapy is considered a routine intervention for rehabilitation. Common physical therapy may require a variety of instruments. One approach that does not need instruments, but...

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Autores principales: Xiao, Bin, Zhao, Lishu, Huang, Yong, Ma, Anqi, Pei, Baoshun, Li, Zhengyu, Gu, Fei
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10262027/
https://www.ncbi.nlm.nih.gov/pubmed/37247222
http://dx.doi.org/10.2196/46054
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author Xiao, Bin
Zhao, Lishu
Huang, Yong
Ma, Anqi
Pei, Baoshun
Li, Zhengyu
Gu, Fei
author_facet Xiao, Bin
Zhao, Lishu
Huang, Yong
Ma, Anqi
Pei, Baoshun
Li, Zhengyu
Gu, Fei
author_sort Xiao, Bin
collection PubMed
description BACKGROUND: Clinical rehabilitation for brachial plexus injury is difficult in terms of chronic pain and dysfunction. Physiotherapy is considered a routine intervention for rehabilitation. Common physical therapy may require a variety of instruments. One approach that does not need instruments, but belongs to the field of complementary and alternative medicine, is naprapathy. Naprapathy, also called Tuina in China, has been applied in rehabilitation after brachial plexus injury for a long time. Naprapathy can relieve chronic neuropathic pain, promote local blood circulation, and improve body edema. Naprapathy can passively help improve motor functions in patients with peripheral nerve injury. However, the efficacy of naprapathy in improving rehabilitation after brachial plexus injury is unclear. OBJECTIVE: This study aims to evaluate the additional value of naprapathy when combined with conventional physical therapy for the treatment of brachial plexus injury. METHODS: This will be a single-center randomized controlled trial. A total of 116 eligible patients with brachial plexus injury will be randomly divided into an experimental group (naprapathy plus physical therapy group) or a control group (physical therapy group). The participants will be followed up for 4 weeks of treatment. Observation outcomes will include the visual analog scale score, upper limb index, electromyography findings, and adverse reactions, among others. The measuring points for outcomes will be the baseline and the completion of treatment. In addition, a quality control group independent from the research team will be set up to control the quality of the trial. Finally, the data will be analyzed using SPSS software (version 21.0; IBM Corp). RESULTS: The study is recruiting participants. The first participant was enrolled in September 2021. As of January 2023, a total of 100 participants have been enrolled. The trial is expected to be completed by September 2023. The study protocol was approved by the Ethics Review Committee of Yue Yang Hospital affiliated with the Shanghai University of Traditional Chinese Medicine (2021-012). CONCLUSIONS: One limitation of this trial is that we will be unable to achieve strict double-blinding because of the features of naprapathy. The trial aims to contribute reliable evidence for decision-making in naprapathy for treating brachial plexus injury. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100043515; http://www.chictr.org.cn/showproj.aspx?proj=122154 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46054
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spelling pubmed-102620272023-06-15 Efficacy of Naprapathy in Brachial Plexus Injury: Protocol for a Randomized Clinical Trial Xiao, Bin Zhao, Lishu Huang, Yong Ma, Anqi Pei, Baoshun Li, Zhengyu Gu, Fei JMIR Res Protoc Protocol BACKGROUND: Clinical rehabilitation for brachial plexus injury is difficult in terms of chronic pain and dysfunction. Physiotherapy is considered a routine intervention for rehabilitation. Common physical therapy may require a variety of instruments. One approach that does not need instruments, but belongs to the field of complementary and alternative medicine, is naprapathy. Naprapathy, also called Tuina in China, has been applied in rehabilitation after brachial plexus injury for a long time. Naprapathy can relieve chronic neuropathic pain, promote local blood circulation, and improve body edema. Naprapathy can passively help improve motor functions in patients with peripheral nerve injury. However, the efficacy of naprapathy in improving rehabilitation after brachial plexus injury is unclear. OBJECTIVE: This study aims to evaluate the additional value of naprapathy when combined with conventional physical therapy for the treatment of brachial plexus injury. METHODS: This will be a single-center randomized controlled trial. A total of 116 eligible patients with brachial plexus injury will be randomly divided into an experimental group (naprapathy plus physical therapy group) or a control group (physical therapy group). The participants will be followed up for 4 weeks of treatment. Observation outcomes will include the visual analog scale score, upper limb index, electromyography findings, and adverse reactions, among others. The measuring points for outcomes will be the baseline and the completion of treatment. In addition, a quality control group independent from the research team will be set up to control the quality of the trial. Finally, the data will be analyzed using SPSS software (version 21.0; IBM Corp). RESULTS: The study is recruiting participants. The first participant was enrolled in September 2021. As of January 2023, a total of 100 participants have been enrolled. The trial is expected to be completed by September 2023. The study protocol was approved by the Ethics Review Committee of Yue Yang Hospital affiliated with the Shanghai University of Traditional Chinese Medicine (2021-012). CONCLUSIONS: One limitation of this trial is that we will be unable to achieve strict double-blinding because of the features of naprapathy. The trial aims to contribute reliable evidence for decision-making in naprapathy for treating brachial plexus injury. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100043515; http://www.chictr.org.cn/showproj.aspx?proj=122154 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46054 JMIR Publications 2023-05-29 /pmc/articles/PMC10262027/ /pubmed/37247222 http://dx.doi.org/10.2196/46054 Text en ©Bin Xiao, Lishu Zhao, Yong Huang, Anqi Ma, Baoshun Pei, Zhengyu Li, Fei Gu. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 29.05.2023. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Xiao, Bin
Zhao, Lishu
Huang, Yong
Ma, Anqi
Pei, Baoshun
Li, Zhengyu
Gu, Fei
Efficacy of Naprapathy in Brachial Plexus Injury: Protocol for a Randomized Clinical Trial
title Efficacy of Naprapathy in Brachial Plexus Injury: Protocol for a Randomized Clinical Trial
title_full Efficacy of Naprapathy in Brachial Plexus Injury: Protocol for a Randomized Clinical Trial
title_fullStr Efficacy of Naprapathy in Brachial Plexus Injury: Protocol for a Randomized Clinical Trial
title_full_unstemmed Efficacy of Naprapathy in Brachial Plexus Injury: Protocol for a Randomized Clinical Trial
title_short Efficacy of Naprapathy in Brachial Plexus Injury: Protocol for a Randomized Clinical Trial
title_sort efficacy of naprapathy in brachial plexus injury: protocol for a randomized clinical trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10262027/
https://www.ncbi.nlm.nih.gov/pubmed/37247222
http://dx.doi.org/10.2196/46054
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