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施式颈椎推拿与按摩治疗颈性眩晕的多中心随机对照临床试验。

Shi-Style Cervical Mobilizations Versus Massage for Cervical Vertigo: A Multicenter, Randomized, Controlled Clinical Trial.

机构信息

Institute of Spine Disease, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Rehabilitation Department, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

J Altern Complement Med. 2020 Jan;26(1):58-66. doi: 10.1089/acm.2019.0113. Epub 2019 Oct 3.

DOI:10.1089/acm.2019.0113
PMID:31580705
Abstract

Large sample and high-quality evidence to evaluate the preliminary safety of the mobilizations and massage for cervical vertigo are not yet available. Thus, the present study aimed to investigate the comparative effectiveness and preliminary safety of Shi-style cervical mobilizations (SCM) compared with traditional massage (TM) in cervical vertigo patients. A prospective, multicenter, open-label, randomized, controlled clinical trial with a 1:1 allocation ratio. Five academic medical centers. A total of 360 adult patients with a diagnosis of cervical vertigo. The patients were randomly allocated to either an SCM ( = 180) or TM ( = 180) group. The patients were treated during six sessions over 2 weeks. The primary outcome was the Dizziness Handicap Inventory (DHI) total scale score, and secondary outcomes included the DHI subscales, Chinese version of the Short-Form 36 Health Survey (CSF-36), and adverse events (AEs). Outcomes were assessed in the short term at 2 weeks, 1 month, and 3 months, and in the intermediate term at 6 months after randomization. Significant changes were observed from the baseline in the DHI total scale and subscales at 2 weeks and 1, 3, and 6 months in both groups (all  < 0.05). However, the differences between the two groups were not significant (all  > 0.05). Furthermore, we noted significant changes from the baseline in SF-36 scores at 2 weeks in both groups (all  < 0.05), whereas CSF-36 scores were not significantly higher in the SCM group (all  > 0.05) compared with the TM group. No serious AEs were reported in either of the two groups. No differences in outcomes were detected between the SCM and TM groups in terms of treatment of cervicogenic dizziness. Efficacy trials are required to determine whether the improvement observed for each treatment was causally related to the interventions.

摘要

大样本和高质量的证据来评估颈椎眩晕推拿和按摩的初步安全性尚不可用。因此,本研究旨在比较研究推拿手法治疗(SCM)与传统按摩(TM)治疗颈椎眩晕的疗效和初步安全性。一项前瞻性、多中心、开放标签、随机、对照临床试验,分配比例为 1:1。五个学术医疗中心。共纳入 360 例成人颈椎眩晕患者。患者随机分为 SCM 组(n=180)或 TM 组(n=180)。患者在 2 周内接受 6 次治疗。主要结局是眩晕残障程度评定量表(DHI)总分,次要结局包括 DHI 各分量表、中文版健康调查简表(CSF-36)和不良事件(AEs)。在短期(2 周、1 个月和 3 个月)和中期(随机分组后 6 个月)评估结局。两组患者在 2 周和 1、3、6 个月时 DHI 总分和各分量表均较基线显著改善(均 P<0.05),但两组间差异无统计学意义(均 P>0.05)。两组患者在 2 周时健康调查简表(SF-36)评分较基线显著改善(均 P<0.05),但 SCM 组 SF-36 评分高于 TM 组(均 P>0.05)。两组均未报告严重不良事件。在治疗颈源性眩晕方面,SCM 组与 TM 组的结局无差异。需要进一步的疗效试验来确定每种治疗方法的改善是否与干预措施有因果关系。

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