Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian), Shenzhen, 518034, Guangdong, China.
Shenzhen Hospital, Southern Medical University, Shenzhen, 518100, Guangdong, China.
Trials. 2021 Jan 12;22(1):53. doi: 10.1186/s13063-020-04955-2.
Upper limb and hand motor dysfunction is one of the challenges in rehabilitation after cerebral ischemic stroke (CIS), and the clinical efficacy of rehabilitation needs to be improved. This study aims to combine Jin's three-needle acupuncture (JTN) therapy with mirror therapy (MT) for hemiplegia after CIS, objectively evaluate the clinical effects and safety of JTN to treat upper limb dysfunction, and use functional magnetic resonance imaging (fMRI) of the brain to investigate the central mechanisms of the effects, which would provide a powerful evidence-based medical basis for further supporting the application of JTN combined with MT.
METHODS/DESIGN: This trial will be a single-blind, randomized controlled study. Patients who meet the study criteria will be recruited and randomly assigned to either the combined treatment group (JTN+MT) or the JTN group. Both interventions will be conducted for 6 days per week and last for 4 weeks. The primary outcome will be the effective rate based on the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Other outcome measures will include scores on the motor assessment scale (MAS), action research arm test (ARAT), activities of daily living (ADL) scale, and fMRI analyses. For safety evaluation, adverse events will be observed and recorded.
This study may help to identify the efficacy and safety of acupuncture combined with MT for upper limb dysfunction after CIS and explore the central mechanisms with brain fMRI.
Chinese Clinical Trial Registry ChiCTR-IOR-17012174 . Registered on 5 April 2017.
上肢和手运动功能障碍是脑缺血性中风（CIS）后康复的挑战之一，需要提高康复的临床疗效。本研究旨在将靳三针疗法（JTN）与镜像疗法（MT）结合治疗 CIS 后偏瘫，客观评价 JTN 治疗上肢功能障碍的临床疗效和安全性，并采用脑功能磁共振成像（fMRI）探讨其作用的中枢机制，为进一步支持 JTN 联合 MT 的应用提供有力的循证医学依据。
方法/设计：这是一项单盲、随机对照研究。符合研究标准的患者将被招募并随机分为联合治疗组（JTN+MT）或 JTN 组。两种干预措施均每周进行 6 天，持续 4 周。主要结局将是基于上肢 Fugl-Meyer 评估（FMA-UE）的有效率。其他结局指标包括运动评估量表（MAS）、动作研究臂测试（ARAT）、日常生活活动（ADL）量表和 fMRI 分析的评分。对于安全性评估，将观察和记录不良事件。
这项研究可能有助于确定针刺联合 MT 治疗 CIS 后上肢功能障碍的疗效和安全性，并利用脑 fMRI 探讨其中枢机制。
中国临床试验注册中心 ChiCTR-IOR-17012174 。注册于 2017 年 4 月 5 日。
