Meng Xiaonan, Wang Liping, Li Chunying, Gao Sen, Yu Haikuo, Zhang Lufen, Sun Jie
Acupuncture Department, Beijing Huguosi TCM Hospital, affiliated with Beijing University of Chinese Medicine, Beijing, People's Republic of China.
Rehablitation Department, Beijing Huguosi TCM Hospital, affiliated with Beijing University of Chinese Medicine, Beijing, People's Republic of China.
J Pain Res. 2022 Mar 3;15:643-653. doi: 10.2147/JPR.S351576. eCollection 2022.
This study aims to evaluate the safety and efficacy of various levels of moxibustion smoke concentration (MSC), represented by particulate matter 10mm (PM), on pain and motor dysfunction in patients with stage 1 post-stroke shoulder-hand syndrome (SHS).
In this multi-center, sham-controlled, single-blind, randomized controlled trial (RCT), a total of 140 eligible patients with stage 1 post-stroke SHS will be recruited from March 2022 to February 2023 and randomly allocated to five groups in a ratio of 1:1:1:1:1. Moxibustion, in addition to standard medical care, will be applied to subjects in all groups. No acupoints on the affected upper limb will be utilized. Moxibustion smoke therapy, with varying levels of MSC, will be applied to the five groups as follows: (A) sham control group, (B) zero MSC group, (C) low MSC group, (D) medium MSC group, and (E) high MSC group. Patients in each group will be treated for 20 minutes per session, with five sessions each week, over a course of six weeks, with a total follow-up interval of eight weeks. The primary outcome measure will be a visual analog scale (VAS) assessment of the intensity of regionalized pain in the affected upper limb. Secondary outcome measures will include scoring on the Fugl-Meyer Assessment of the Upper Extremity Scale (FMA-UE), the Modified Barthel Index (MBI) and the measurement of somatosensory evoked potential (SEP). All participants will be evaluated before treatment, during treatment (ie, at two weeks and four weeks), immediately after concluding treatment (ie, at six weeks) and at two weeks post-treatment (ie, at eight weeks). Intention-to-treat analysis will be applied.
ChiCTR2100043076.
本研究旨在评估以10毫米颗粒物（PM）为代表的不同水平艾灸烟雾浓度（MSC）对中风后肩手综合征（SHS）1期患者疼痛和运动功能障碍的安全性和有效性。
在这项多中心、假对照、单盲随机对照试验（RCT）中，2022年3月至2023年2月期间将招募140例符合条件的中风后SHS 1期患者，并按1:1:1:1:1的比例随机分为五组。除标准医疗护理外，所有组的受试者都将接受艾灸。不使用患侧上肢的穴位。将对五组应用不同水平MSC的艾灸烟雾疗法，如下：（A）假对照组，（B）零MSC组，（C）低MSC组，（D）中MSC组，（E）高MSC组。每组患者每次治疗20分钟，每周五次，疗程六周，总随访间隔为八周。主要结局指标将是对患侧上肢局部疼痛强度的视觉模拟量表（VAS）评估。次要结局指标将包括上肢Fugl-Meyer评估量表（FMA-UE）评分、改良Barthel指数（MBI）以及体感诱发电位（SEP）测量。所有参与者将在治疗前、治疗期间（即两周和四周时）、治疗结束后立即（即六周时）以及治疗后两周（即八周时）进行评估。将采用意向性分析。
ChiCTR2100043076。
