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

ObjectiveWith a higher incidence rate among the younger population, cervical vertigo (CV) can impose a significant burden on patients with CV. It is believed that a deficiency of qi and blood is the primary pathogenesis in Traditional Chinese medicine (TCM). Acupuncture is a vital strategy for CV, b...

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Main Authors: Zhuanzhuan Hou, Jun Tian, Yuewei Jin, Huida Yu, Weigang Wu, Miaomiao Wei, Shibing Xu
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-06-01
Series:Frontiers in Neurology
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Online Access:https://www.frontiersin.org/articles/10.3389/fneur.2025.1476596/full
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author Zhuanzhuan Hou
Jun Tian
Yuewei Jin
Huida Yu
Weigang Wu
Miaomiao Wei
Shibing Xu
author_facet Zhuanzhuan Hou
Jun Tian
Yuewei Jin
Huida Yu
Weigang Wu
Miaomiao Wei
Shibing Xu
author_sort Zhuanzhuan Hou
collection DOAJ
description ObjectiveWith a higher incidence rate among the younger population, cervical vertigo (CV) can impose a significant burden on patients with CV. It is believed that a deficiency of qi and blood is the primary 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.MethodsThis was a single-center, assessor-, and analyst-blinded, prospective randomized controlled trial that involved treatment for 6 weeks and follow-up for 24 weeks. Ninety-nine patients with CV 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. In contrast, the patients in the control-1 group 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 (CVS-FAS) score and qi and Blood Deficiency Symptoms Assessment Scale (QBD-SAS) score. 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 and after 6 weeks of treatment. Primary outcomes will be evaluated at 12 and 24 weeks of follow-up. Adverse events (AEs) were evaluated during treatment and follow-up periods.ResultsThis study aimed to determine whether TNRM-UN is more effective than current acupuncture therapies by providing compelling evidence and deciding whether TNRM-UN can be used as a promising therapy for CV with a deficiency of qi and blood.Clinical trial registrationhttps://www.chictr.org.cn/, identifier: ChiCTR2400080759.
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publisher Frontiers Media S.A.
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spelling doaj-art-eec8534d981346e4a5dbe51499cf77232025-08-20T03:21:51ZengFrontiers Media S.A.Frontiers in Neurology1664-22952025-06-011610.3389/fneur.2025.14765961476596Three-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 trialZhuanzhuan Hou0Jun Tian1Yuewei Jin2Huida Yu3Weigang Wu4Miaomiao Wei5Shibing Xu6Department of Acupuncture and Moxibustion, The Third People's Hospital of Xiaoshan District, Hangzhou, ChinaDepartment of Acupuncture and Moxibustion, The Third People's Hospital of Xiaoshan District, Hangzhou, ChinaDepartment of Acupuncture and Moxibustion, The Third People's Hospital of Xiaoshan District, Hangzhou, ChinaDepartment of Acupuncture and Moxibustion, The Third People's Hospital of Xiaoshan District, Hangzhou, ChinaDepartment of Acupuncture and Moxibustion, The Third People's Hospital of Xiaoshan District, Hangzhou, ChinaDepartment of Acupuncture and Moxibustion, The Third People's Hospital of Xiaoshan District, Hangzhou, ChinaDepartment of Orthopedics, The First People's Hospital of Xiaoshan District, Xiaoshan Affiliated Hospital of Wenzhou Medical University, Hangzhou, ChinaObjectiveWith a higher incidence rate among the younger population, cervical vertigo (CV) can impose a significant burden on patients with CV. It is believed that a deficiency of qi and blood is the primary 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.MethodsThis was a single-center, assessor-, and analyst-blinded, prospective randomized controlled trial that involved treatment for 6 weeks and follow-up for 24 weeks. Ninety-nine patients with CV 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. In contrast, the patients in the control-1 group 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 (CVS-FAS) score and qi and Blood Deficiency Symptoms Assessment Scale (QBD-SAS) score. 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 and after 6 weeks of treatment. Primary outcomes will be evaluated at 12 and 24 weeks of follow-up. Adverse events (AEs) were evaluated during treatment and follow-up periods.ResultsThis study aimed to determine whether TNRM-UN is more effective than current acupuncture therapies by providing compelling evidence and deciding whether TNRM-UN can be used as a promising therapy for CV with a deficiency of qi and blood.Clinical trial registrationhttps://www.chictr.org.cn/, identifier: ChiCTR2400080759.https://www.frontiersin.org/articles/10.3389/fneur.2025.1476596/fullcervical vertigodeficiency of qi and bloodthree-needle of regulating the mindumbilical needlerandomized controlled trial
spellingShingle Zhuanzhuan Hou
Jun Tian
Yuewei Jin
Huida Yu
Weigang Wu
Miaomiao Wei
Shibing Xu
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
Frontiers in Neurology
cervical vertigo
deficiency of qi and blood
three-needle of regulating the mind
umbilical needle
randomized controlled trial
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic cervical vertigo
deficiency of qi and blood
three-needle of regulating the mind
umbilical needle
randomized controlled trial
url https://www.frontiersin.org/articles/10.3389/fneur.2025.1476596/full
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