The clinical effects and biomechanical mechanisms of Peony and licorice decoction fumigation in the treatment of poststroke cavovarus foot: study protocol for a randomized controlled pilot trial

The clinical effects and biomechanical mechanisms of Peony and licorice decoction fumigation in the treatment of poststroke cavovarus foot: study protocol for a randomized controlled pilot trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol The clinical effects and biomechanical mechanisms of Peony and licorice decoction fumigation in the treatment of poststroke cavovarus foot: study protocol for a randomized controlled pilot trial Chengyang Jing, Li Zhou, Juanjuan Ai, Zongheng Li, Jiabao Wu, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-31548/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: As the most common functional disability in stroke patients with hemiplegia, poststroke cavovarus foot (PCF) seriously affects the life quality of patients and causes mental and emotional disorders. Some studies have suggested that the traditional Chinese medicine fumigation therapy could be an effective intervention method for PCF patients. This study aims to investigate the biomechanical effect of the classic prescription Peony and licorice decoction (PLD) fumigation in the treatment of PCF. Methods/Design: This study is a multi-center, randomized, placebo-controlled, double blind trial. A total of 190 patients with PCF according to the inclusion criteria will be recruited in three centers and randomized and distributed to either the intervention group or the control group at a 1:1 ratio. All patients will receive standardized modern rehabilitation treatment according to the “Chinese Guidelines for Stroke Rehabilitation” (2011 version). Patients will stick to the treatments they used to take, and will be given present general treatment when acute exacerbation of stroke occurs during the trial. The intervention group will receive PLD fumigation treatment, while the control group will receive placebo fumigation treatment. The primary outcome measure is medial plantar area (M1＋M2＋HM) generating from the RSSCAN gait system. The secondary outcome measures contain the scores of clinical scales including Berg Balance Scale, Fugl-Meyer Assessment, Modified Ashworth Scale, Barthel Index, and Stroke-Specific Quality of Life Scale. All assessments will be implemented at baseline, 4 weeks after intervention and at the end of 3 month’ follow-up. Intention-to-treat analysis and per-protocol analysis will be applied in this trial. Discussion: The results of this study are expected to provide detailed interpretations of clinical effects and biomechanical mechanisms of PLD fumigation in the treatment of PCF. If PLD fumigation treatment is confirmed as an effective option, this study may additionally set up the new treatment method for patients with PCF and provide foundations for further clinical studies on a larger scale. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000032433. Registered on 28 April 2020. Integrative & Complementary Medicine Translational Medicine Biomechanical mechanisms Peony and licorice decoction fumigation therapy poststroke cavovarus foot Multi-center randomized controlled trial Study protocol Figures Figure 1 Full Text Supplementary Files EthicsapprovalfileEnglishVersion.pdf FundingfileChineseVersionoriginaledition.pdf Additionalfile1SPIRITchecklist.pdf EthicsapprovalfileChineseVersionoriginaledition.jpg FundingfileEnglishVersion.pdf Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-31548","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":633647,"identity":"cf7253a3-bb5b-49d6-b19c-a74bdc8bbe8c","order_by":0,"name":"Chengyang Jing","email":"","orcid":"","institution":"Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Chengyang","middleName":"","lastName":"Jing","suffix":""},{"id":633648,"identity":"5b92710d-a60a-41de-8558-b93972f65bfd","order_by":1,"name":"Li Zhou","email":"","orcid":"","institution":"Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Li","middleName":"","lastName":"Zhou","suffix":""},{"id":633649,"identity":"0d476b21-71fd-4188-a346-d4d20f50e11d","order_by":2,"name":"Juanjuan Ai","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA4ElEQVRIie3QvQrCMBDA8UggLsGuEWuLbxAo9HkSCp0UOnZwqCh2sIqjvkVHx4RCprh3VHyBujkIfsxKWzeH/Of7wd0BYDL9YciViWD04VjduTyxeNpMegRKUUXQ62cqoCetmolDUCB3FeR5Ofb75wVssdggowWmiOciDGOeIGClK1ZPbP0m2NuLQpX8YAOij3k9AeM3IcONXIYl1whQMmlFaCcpsB/xJWxBSMjkjrLRVmEftCO4EKKi4vVkFBCmFW68xU1n84rdhWO5F3m9xVPHStf15CP827jJZDKZvvYEivdQ7WeM9usAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-5138-7298","institution":"Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine","correspondingAuthor":true,"prefix":"","firstName":"Juanjuan","middleName":"","lastName":"Ai","suffix":""},{"id":633650,"identity":"cc56c9d5-4872-4f79-b918-9dbfb58a45e0","order_by":3,"name":"Zongheng Li","email":"","orcid":"","institution":"Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Zongheng","middleName":"","lastName":"Li","suffix":""},{"id":633651,"identity":"767de002-af36-4b30-832c-09ef0abb5998","order_by":4,"name":"Jiabao Wu","email":"","orcid":"","institution":"Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Jiabao","middleName":"","lastName":"Wu","suffix":""},{"id":633652,"identity":"55ae3a64-13d1-429b-87ce-0295e481eae5","order_by":5,"name":"Yiting Sun","email":"","orcid":"","institution":"Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Yiting","middleName":"","lastName":"Sun","suffix":""},{"id":633653,"identity":"63343f23-93cb-4aa5-a697-bb5361721836","order_by":6,"name":"Shuang Zhao","email":"","orcid":"","institution":"Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Shuang","middleName":"","lastName":"Zhao","suffix":""}],"badges":[],"createdAt":"2020-05-26 03:23:41","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-31548/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-31548/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":1262888,"identity":"d5b2eb0d-4b38-43d3-8d9e-ca5193ac26e5","added_by":"auto","created_at":"2020-06-05 14:44:20","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":55387,"visible":true,"origin":"","legend":"Flow chart of study design. 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PDF\u003c/a\u003e.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":" Biomechanical mechanisms, Peony and licorice decoction, fumigation therapy, poststroke cavovarus foot, Multi-center randomized controlled trial, Study protocol","lastPublishedDoi":"10.21203/rs.3.rs-31548/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-31548/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground: As the most common functional disability in stroke patients with hemiplegia, poststroke cavovarus foot (PCF) seriously affects the life quality of patients and causes mental and emotional disorders. Some studies have suggested that the traditional Chinese medicine fumigation therapy could be an effective intervention method for PCF patients. This\u0026nbsp;study aims\u0026nbsp;to investigate the biomechanical effect of the classic prescription Peony and licorice decoction (PLD) fumigation in the treatment of\u0026nbsp;PCF. \u003c/p\u003e\u003cp\u003eMethods/Design: This study\u0026nbsp;is a multi-center, randomized, placebo-controlled, double\u0026nbsp;blind trial. A total of 190 patients with PCF according\u0026nbsp;to the\u0026nbsp;inclusion criteria will be recruited in three centers and randomized and distributed to either the intervention\u0026nbsp;group or the control group at\u0026nbsp;a 1:1 ratio. All patients will receive standardized modern rehabilitation treatment according to the “Chinese Guidelines for Stroke Rehabilitation”\u0026nbsp;(2011 version). Patients will stick to the treatments they used to take, and will be given present general treatment when acute exacerbation of stroke occurs during the trial. The intervention\u0026nbsp;group will receive PLD fumigation treatment, while the control group will receive placebo fumigation treatment. The primary outcome measure is medial plantar area (M1＋M2＋HM)\u0026nbsp;generating from the RSSCAN gait system. The secondary outcome measures contain the scores of clinical scales including Berg Balance Scale, Fugl-Meyer Assessment, Modified Ashworth Scale, Barthel Index, and Stroke-Specific Quality of Life Scale. All assessments will be implemented at baseline, 4 weeks after intervention and at the end of 3 month’ follow-up. Intention-to-treat analysis and per-protocol analysis will be applied in this trial. \u003c/p\u003e\u003cp\u003eDiscussion: The results of this study are expected to provide detailed interpretations of clinical effects\u0026nbsp;and biomechanical mechanisms\u0026nbsp;of PLD fumigation in the treatment of PCF. If PLD fumigation treatment is confirmed as an effective option, this study may additionally set up the\u0026nbsp;new treatment method for patients with PCF and provide foundations for further clinical studies\u0026nbsp;on a larger scale. \u003c/p\u003e\u003cp\u003eTrial registration: Chinese Clinical Trial Registry, ChiCTR2000032433. Registered on\u0026nbsp;28 April 2020. \u003c/p\u003e","manuscriptTitle":"The clinical effects and biomechanical mechanisms of Peony and licorice decoction fumigation in the treatment of poststroke cavovarus foot: study protocol for a randomized controlled pilot trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2020-06-05 14:44:20","doi":"10.21203/rs.3.rs-31548/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"9eb49af8-3649-437a-8ca4-5b1b6af0b874","owner":[],"postedDate":"June 5th, 2020","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":114276,"name":"Integrative \u0026 Complementary Medicine"},{"id":114277,"name":"Translational Medicine"}],"tags":[],"updatedAt":"2020-09-18T21:35:52+00:00","versionOfRecord":[],"versionCreatedAt":"2020-06-05 14:44:20","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-31548","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-31548","identity":"rs-31548","version":["v1"]},"buildId":"_2-kVJe1T_tPrBINL-cwx","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}