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Safety and efficacy of traditional Chinese manual therapy for cervicogenic dizziness: study protocol for a randomized, controlled, multicenter trial.
Zhan, Yunfan; Zhang, Yujie; Liu, Kaoqiang; Zhao, Ye; Ning, Jiawei; Chai, Yongli; Kong, Lingjun; Yuan, Weian.
Afiliação
  • Zhan Y; Shuguang Hospital Affiliated with Shanghai University of TCM, Shanghai, 201203, China.
  • Zhang Y; Shuguang Hospital Affiliated with Shanghai University of TCM, Shanghai, 201203, China.
  • Liu K; Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
  • Zhao Y; Shuguang Hospital Affiliated with Shanghai University of TCM, Shanghai, 201203, China.
  • Ning J; Shuguang Hospital Affiliated with Shanghai University of TCM, Shanghai, 201203, China.
  • Chai Y; Shuguang Hospital Affiliated with Shanghai University of TCM, Shanghai, 201203, China.
  • Kong L; Shuguang Hospital Affiliated with Shanghai University of TCM, Shanghai, 201203, China.
  • Yuan W; Shuguang Hospital Affiliated with Shanghai University of TCM, Shanghai, 201203, China.
Contemp Clin Trials Commun ; 41: 101349, 2024 Oct.
Article em En | MEDLINE | ID: mdl-39262903
ABSTRACT

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 11. 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. Protocol version 1.0, November 20, 2022.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Contemp Clin Trials Commun Ano de publicação: 2024 Tipo de documento: Article País de afiliação: China País de publicação: Holanda
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Contemp Clin Trials Commun Ano de publicação: 2024 Tipo de documento: Article País de afiliação: China País de publicação: Holanda