Yunfan Zhan , Yujie Zhang , Kaoqiang Liu , Ye Zhao , Jiawei Ning , Yongli Chai , Lingjun Kong , Weian Yuan
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Patients will be randomly allocated to the intervention group and the control group at a ratio of 1:1. Participants in the control group will be treated with Merislon (Betahistine Mesilate Tablets). Participants in the intervention group will be treated with SMT. The primary outcome is the response rate at week 2, which is defined as the proportion of patients who reduce their disability level measured by the Dizziness Handicap Inventory (DHI) score relative to baseline. Key secondary outcomes include DHI scores at weeks 1, 2, and 6 and changes from baseline, time to disappearance of dizziness symptoms, and recurrence rate of dizziness symptoms. Safety will be assessed by adverse events, physical examination and vital signs.</p></div><div><h3>Discussion</h3><p>This trial aims to provide high-quality evidence-based medical data to demonstrate that SMT can reduce dizziness in patients with cervicogenic dizziness effectively and safely.</p></div><div><h3>Trial registration</h3><p>Clinical Trial Registration Center NCT05604937. Registered on Nov 3, 2022.</p></div><div><h3>Protocol version</h3><p>1.0, November 20, 2022.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"41 ","pages":"Article 101349"},"PeriodicalIF":1.4000,"publicationDate":"2024-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000966/pdfft?md5=0746cb8292b1b0a677d7c51adf67a5b1&pid=1-s2.0-S2451865424000966-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Safety and efficacy of traditional Chinese manual therapy for cervicogenic dizziness: study protocol for a randomized, controlled, multicenter trial\",\"authors\":\"Yunfan Zhan , Yujie Zhang , Kaoqiang Liu , Ye Zhao , Jiawei Ning , Yongli Chai , Lingjun Kong , Weian Yuan\",\"doi\":\"10.1016/j.conctc.2024.101349\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Cervicogenic dizziness is a clinical syndrome characterized by neck pain and dizziness, which has a rising incidence in recent years. In China, manual therapy has been widely used in the treatment of cervicogenic dizziness, but there is no high-quality medical evidence to support its effectiveness and safety. The purpose of this study was to assess the safety and efficacy of Shi's manual therapy (SMT) on the treatment of cervicogenic dizziness.</p></div><div><h3>Methods</h3><p>A multicenter randomized controlled trial (RCT) will perform on 106 patients (18≤ages≤65) who meet the diagnostic criteria of cervicogenic dizziness. Patients will be randomly allocated to the intervention group and the control group at a ratio of 1:1. Participants in the control group will be treated with Merislon (Betahistine Mesilate Tablets). Participants in the intervention group will be treated with SMT. The primary outcome is the response rate at week 2, which is defined as the proportion of patients who reduce their disability level measured by the Dizziness Handicap Inventory (DHI) score relative to baseline. Key secondary outcomes include DHI scores at weeks 1, 2, and 6 and changes from baseline, time to disappearance of dizziness symptoms, and recurrence rate of dizziness symptoms. Safety will be assessed by adverse events, physical examination and vital signs.</p></div><div><h3>Discussion</h3><p>This trial aims to provide high-quality evidence-based medical data to demonstrate that SMT can reduce dizziness in patients with cervicogenic dizziness effectively and safely.</p></div><div><h3>Trial registration</h3><p>Clinical Trial Registration Center NCT05604937. 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Safety and efficacy of traditional Chinese manual therapy for cervicogenic dizziness: study protocol for a randomized, controlled, multicenter trial
Background
Cervicogenic dizziness is a clinical syndrome characterized by neck pain and dizziness, which has a rising incidence in recent years. In China, manual therapy has been widely used in the treatment of cervicogenic dizziness, but there is no high-quality medical evidence to support its effectiveness and safety. The purpose of this study was to assess the safety and efficacy of Shi's manual therapy (SMT) on the treatment of cervicogenic dizziness.
Methods
A multicenter randomized controlled trial (RCT) will perform on 106 patients (18≤ages≤65) who meet the diagnostic criteria of cervicogenic dizziness. Patients will be randomly allocated to the intervention group and the control group at a ratio of 1:1. Participants in the control group will be treated with Merislon (Betahistine Mesilate Tablets). Participants in the intervention group will be treated with SMT. The primary outcome is the response rate at week 2, which is defined as the proportion of patients who reduce their disability level measured by the Dizziness Handicap Inventory (DHI) score relative to baseline. Key secondary outcomes include DHI scores at weeks 1, 2, and 6 and changes from baseline, time to disappearance of dizziness symptoms, and recurrence rate of dizziness symptoms. Safety will be assessed by adverse events, physical examination and vital signs.
Discussion
This trial aims to provide high-quality evidence-based medical data to demonstrate that SMT can reduce dizziness in patients with cervicogenic dizziness effectively and safely.
Trial registration
Clinical Trial Registration Center NCT05604937. Registered on Nov 3, 2022.
期刊介绍：
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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