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Efficacy of Moxibustion Smoke for Stage 1 Post-Stroke Shoulder-Hand Syndrome: Protocol for a Multi-Center, Single-Blind Randomized Sham-Controlled Trial
OBJECTIVE: This study aims to evaluate the safety and efficacy of various levels of moxibustion smoke concentration (MSC), represented by particulate matter 10mm (PM(10)), on pain and motor dysfunction in patients with stage 1 post-stroke shoulder-hand syndrome (SHS). MATERIALS AND METHODS: In this...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Dove
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8901261/ https://www.ncbi.nlm.nih.gov/pubmed/35264882 http://dx.doi.org/10.2147/JPR.S351576 |
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author | Meng, Xiaonan Wang, Liping Li, Chunying Gao, Sen Yu, Haikuo Zhang, Lufen Sun, Jie |
author_facet | Meng, Xiaonan Wang, Liping Li, Chunying Gao, Sen Yu, Haikuo Zhang, Lufen Sun, Jie |
author_sort | Meng, Xiaonan |
collection | PubMed |
description | OBJECTIVE: This study aims to evaluate the safety and efficacy of various levels of moxibustion smoke concentration (MSC), represented by particulate matter 10mm (PM(10)), on pain and motor dysfunction in patients with stage 1 post-stroke shoulder-hand syndrome (SHS). MATERIALS AND METHODS: In this multi-center, sham-controlled, single-blind, randomized controlled trial (RCT), a total of 140 eligible patients with stage 1 post-stroke SHS will be recruited from March 2022 to February 2023 and randomly allocated to five groups in a ratio of 1:1:1:1:1. Moxibustion, in addition to standard medical care, will be applied to subjects in all groups. No acupoints on the affected upper limb will be utilized. Moxibustion smoke therapy, with varying levels of MSC, will be applied to the five groups as follows: (A) sham control group, (B) zero MSC group, (C) low MSC group, (D) medium MSC group, and (E) high MSC group. Patients in each group will be treated for 20 minutes per session, with five sessions each week, over a course of six weeks, with a total follow-up interval of eight weeks. The primary outcome measure will be a visual analog scale (VAS) assessment of the intensity of regionalized pain in the affected upper limb. Secondary outcome measures will include scoring on the Fugl-Meyer Assessment of the Upper Extremity Scale (FMA-UE), the Modified Barthel Index (MBI) and the measurement of somatosensory evoked potential (SEP). All participants will be evaluated before treatment, during treatment (ie, at two weeks and four weeks), immediately after concluding treatment (ie, at six weeks) and at two weeks post-treatment (ie, at eight weeks). Intention-to-treat analysis will be applied. TRIAL REGISTRATION NUMBER: ChiCTR2100043076. |
format | Online Article Text |
id | pubmed-8901261 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-89012612022-03-08 Efficacy of Moxibustion Smoke for Stage 1 Post-Stroke Shoulder-Hand Syndrome: Protocol for a Multi-Center, Single-Blind Randomized Sham-Controlled Trial Meng, Xiaonan Wang, Liping Li, Chunying Gao, Sen Yu, Haikuo Zhang, Lufen Sun, Jie J Pain Res Study Protocol OBJECTIVE: This study aims to evaluate the safety and efficacy of various levels of moxibustion smoke concentration (MSC), represented by particulate matter 10mm (PM(10)), on pain and motor dysfunction in patients with stage 1 post-stroke shoulder-hand syndrome (SHS). MATERIALS AND METHODS: In this multi-center, sham-controlled, single-blind, randomized controlled trial (RCT), a total of 140 eligible patients with stage 1 post-stroke SHS will be recruited from March 2022 to February 2023 and randomly allocated to five groups in a ratio of 1:1:1:1:1. Moxibustion, in addition to standard medical care, will be applied to subjects in all groups. No acupoints on the affected upper limb will be utilized. Moxibustion smoke therapy, with varying levels of MSC, will be applied to the five groups as follows: (A) sham control group, (B) zero MSC group, (C) low MSC group, (D) medium MSC group, and (E) high MSC group. Patients in each group will be treated for 20 minutes per session, with five sessions each week, over a course of six weeks, with a total follow-up interval of eight weeks. The primary outcome measure will be a visual analog scale (VAS) assessment of the intensity of regionalized pain in the affected upper limb. Secondary outcome measures will include scoring on the Fugl-Meyer Assessment of the Upper Extremity Scale (FMA-UE), the Modified Barthel Index (MBI) and the measurement of somatosensory evoked potential (SEP). All participants will be evaluated before treatment, during treatment (ie, at two weeks and four weeks), immediately after concluding treatment (ie, at six weeks) and at two weeks post-treatment (ie, at eight weeks). Intention-to-treat analysis will be applied. TRIAL REGISTRATION NUMBER: ChiCTR2100043076. Dove 2022-03-03 /pmc/articles/PMC8901261/ /pubmed/35264882 http://dx.doi.org/10.2147/JPR.S351576 Text en © 2022 Meng 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 Meng, Xiaonan Wang, Liping Li, Chunying Gao, Sen Yu, Haikuo Zhang, Lufen Sun, Jie Efficacy of Moxibustion Smoke for Stage 1 Post-Stroke Shoulder-Hand Syndrome: Protocol for a Multi-Center, Single-Blind Randomized Sham-Controlled Trial |
title | Efficacy of Moxibustion Smoke for Stage 1 Post-Stroke Shoulder-Hand Syndrome: Protocol for a Multi-Center, Single-Blind Randomized Sham-Controlled Trial |
title_full | Efficacy of Moxibustion Smoke for Stage 1 Post-Stroke Shoulder-Hand Syndrome: Protocol for a Multi-Center, Single-Blind Randomized Sham-Controlled Trial |
title_fullStr | Efficacy of Moxibustion Smoke for Stage 1 Post-Stroke Shoulder-Hand Syndrome: Protocol for a Multi-Center, Single-Blind Randomized Sham-Controlled Trial |
title_full_unstemmed | Efficacy of Moxibustion Smoke for Stage 1 Post-Stroke Shoulder-Hand Syndrome: Protocol for a Multi-Center, Single-Blind Randomized Sham-Controlled Trial |
title_short | Efficacy of Moxibustion Smoke for Stage 1 Post-Stroke Shoulder-Hand Syndrome: Protocol for a Multi-Center, Single-Blind Randomized Sham-Controlled Trial |
title_sort | efficacy of moxibustion smoke for stage 1 post-stroke shoulder-hand syndrome: protocol for a multi-center, single-blind randomized sham-controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8901261/ https://www.ncbi.nlm.nih.gov/pubmed/35264882 http://dx.doi.org/10.2147/JPR.S351576 |
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