STUDY PROTOCOL article
Front. Neurol.
Sec. Experimental Therapeutics
Volume 16 - 2025 | doi: 10.3389/fneur.2025.1476596
This article is part of the Research TopicChallenges and Current Research Status of Vertigo/Vestibular Diseases Volume IIIView all 16 articles
Three-needle of regulating the mind combined with umbilical needle intervention for cervical vertigo with deficiency of qi and blood:a study protocol for a randomized controlled trial
Provisionally accepted
- 1Department of acupuncture and moxibustion, Third People's Hospital of Xiaoshan District, Hangzhou, Hangzhou, China
- 2Department of orthopedics, The First people's Hospital of Xiaoshan District, Hangzhou, Jiangsu Province, China
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With a higher and younger incidence rate,cervical vertigo(CV) can cause a huge burden to the patients with CV. It is considered that deficiency of qi and blood is a main pathogenesis in Traditional Chinese medicine (TCM). Acupuncture is a vital strategy for CV, but the efficacy of current acupuncture therapies remains unsatisfactory. thus, this randomized controlled study will assess the safety and effectiveness of three-needle of regulating the mind combined with umbilical needle (TNRM-UN) therapy for CV with qi and blood deficiency.Methods:This was a single-center, assessor and analyst-blinded,prospective randomized controlled trial, including treatment for 6weeks and follow-up for 24weeks.Ninety-nine patients with CV with deficiency of qi and blood are randomly allocated to three groups in a 1:1:1 ratio.The patients in the observation group will receive three-needle of regulating the mind combined with umbilical needle (TNRM-UN) therapy,while the patients in the control 1group will receive three-needle of regulating the mind combined with traditional acupuncture(TNRM-TA) and the patients in the control 2 group will receive only umbilical needle (UN) therapy.Primary outcomes include Cervical Vertigo Symptom and Functional Assessment Scale score(CVS-FAS) and Qi and Blood Deficiency Symptoms Assessment Scale score(QBD-SAS). The secondary outcomes are hemodynamic changes in the bilateral vertebral arteries,including diameter value(DV), peak systolic velocity(PSV),end-diastolic velocity(EDV), pulsatility index(PI), and resistance index(RI). All outcome measurements will be evaluated before treatment and after 6 weeks of treatment.Primary outcomes will be evaluated at 12, 24weeks follow-up.Adverse events were evaluated during treatment and follow-up periods.Results: This study aimed to determine whether TNRM-UN is more effective than current acupuncture therapies by providing effective evidence and deciding whether TNRM-UN can be used as a promising therapy for CV with deficiency of qi and blood.
Keywords: Trial Registration: www.ClinicalTrials.gov identifier: ChiCTR2400080759 cervical vertigo, deficiency of qi and blood, three-needle of regulating the mind, Umbilical needle, randomized controlled trial
Received: 27 Sep 2024; Accepted: 19 May 2025.
Copyright: © 2025 Hou, Tian, Jin, Yu, Wu, Wei and Xu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Shibing Xu, Department of orthopedics, The First people's Hospital of Xiaoshan District, Hangzhou, Jiangsu Province, China
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