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: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-06-01
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| Series: | Frontiers in Neurology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2025.1476596/full |
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| Summary: | 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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| ISSN: | 1664-2295 |