新型梅花针温和灸装置治疗脑卒中后肩手综合征1期患者上肢疼痛障碍和运动功能障碍的疗效与安全性：一项多中心、单盲、随机假对照试验的研究方案
Efficacy and Safety of a Novel Plum Blossom Needling with Mild Moxibustion Device for Upper Limb Pain Disorder and Motor Dysfunction in Patients with Stage 1 Post-Stroke Shoulder-Hand Syndrome: Study Protocol for a Multi-Center, Single-Blind, Randomized Sham-Controlled Trial.
作者信息
Meng Xiaonan, Sun Jie, Liu Qi, Huang Yueping, Qiu Xianwen, Seto David Jung, Li Ying, Wang Liping, Li Chunying, Gao Sen, Yu Haikuo, Zhao Jiping, Zhao Baixiao
机构信息
Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China.
Department of Acupuncture and Moxibustion, Beijing Huguosi TCM Hospital, Affiliated with Beijing University of Chinese Medicine, Beijing, People's Republic of China.
出版信息
J Pain Res. 2023 Feb 13;16:407-420. doi: 10.2147/JPR.S396195. eCollection 2023.
BACKGROUND
Post-stroke shoulder-hand syndrome (PS-SHS), a common neurological comorbidity after stroke episodes, poses a grave threat on patients' functional recovery. Preliminary trials have demonstrated that the acupuncture and moxibustion treatment, including a dermal acupuncture tapping method known as plum blossom needling (PBN) can improve pain and motor dysfunctions in patients with PS-SHS. However, there are few reports describing simultaneous moxibustion treatment in combination with PBN. Hence, a novel plum blossom needle device with mild moxibustion (PBNMM) was developed to evaluate its potential efficacy and safety in patients with stage 1 PS-SHS.
MATERIALS AND METHODS
This multicenter, sham-controlled, randomized controlled trial (RCT) will recruit 102 eligible patients with stage 1 PS-SHS from three clinical centers, randomly allocated in a ratio of 1:1:1 to the PBNMM group, PBNMM with no moxa smoke (PBNMM-NMS) group and sham control group. Patients in each group will receive a 30-minute treatment once per day for 4 weeks, with 5 consecutive sessions per week, for a total of 20 sessions. The primary outcome measure will be defined as the decreased scores from baseline in the visual analog scale (VAS) assessment at week 4. Secondary outcome measures will include scores on the Fugl-Meyer Assessment of the Upper Extremity Scale (FMA-UE), the Modified Barthel Index (MBI), and the somatosensory evoked potential (SEP) records. All outcomes will be evaluated at baseline and weeks 4, 5, 6 and 10, and the intention-to-treat analysis will be applied.
CONCLUSION
This study aims to provide robust evidence for the efficacy and safety of the PBNMM for PS-SHS treatment, as well as the specific impact of moxibustion smoke itself in dealing with PS-SHS.
CLINICAL TRIAL REGISTRATION
Chinese Clinical Trial Registry No. ChiCTR2200062441. Registered on 7 August 2022.
背景
中风后肩手综合征（PS-SHS）是中风发作后常见的神经合并症，对患者的功能恢复构成严重威胁。初步试验表明，针灸治疗，包括一种称为梅花针叩刺法（PBN）的皮肤针刺方法，可以改善PS-SHS患者的疼痛和运动功能障碍。然而，很少有报告描述同时进行艾灸治疗与PBN相结合的情况。因此，开发了一种新型的带有温和艾灸的梅花针装置（PBNMM），以评估其在1期PS-SHS患者中的潜在疗效和安全性。
材料与方法
这项多中心、假对照、随机对照试验（RCT）将从三个临床中心招募102名符合条件的1期PS-SHS患者，按1:1:1的比例随机分配到PBNMM组、无艾灸烟雾的PBNMM组（PBNMM-NMS）和假对照组。每组患者每天接受一次30分钟的治疗，共4周，每周连续治疗5次，总共20次。主要结局指标将定义为第4周时视觉模拟量表（VAS）评估中相对于基线的得分降低。次要结局指标将包括上肢Fugl-Meyer评估量表（FMA-UE）、改良Barthel指数（MBI）和体感诱发电位（SEP）记录的得分。所有结局指标将在基线以及第4、5、6和10周进行评估，并将采用意向性分析。
结论
本研究旨在为PBNMM治疗PS-SHS的疗效和安全性以及艾灸烟雾本身在治疗PS-SHS中的具体影响提供有力证据。
临床试验注册
中国临床试验注册中心注册号ChiCTR2200062441。于2022年8月7日注册。
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