Liu Tong, Wen Xi, Kuang Weichuan, Wang Xiaoyin, Jiang Ye, Qiu Xiaojia, Zeng Yao, Zhang Guitao, Yu Jiani, Liu Yue
Department of Acupuncture and Rehabilitation, GuangDong Second Hospital of Traditional Chinese Medicine.
Department of Acupuncture and Rehabilitation, Guangzhou University of Chinese Medicine.
Medicine (Baltimore). 2019 May;98(19):e15507. doi: 10.1097/MD.0000000000015507.
Hemiplegic shoulder pain (HSP) is a frequent complication after stroke and limits patients' physical functioning of the affected arm, thus compromising their quality of life. Fu's subcutaneous needling (FSN) has been widely applied in the treatment of pain diseases in China; however, its efficacy and safety for HSP remain to be elucidated. We therefore conducted a randomized, controlled trial to summarize the current evidence on the effects of FSN on the recovery outcomes of stroke survivors with HSP.
Here, we conduct a study design and protocol of a randomized, blinded, controlled study to evaluate the efficacy and safety of FSN in patients with HSP. A total of 60 patients with numerical rating scale (NRS) score above 1 will be recruited in the trial and randomized into FSN group or usual care (UC) group. Patients in the FSN group will receive FSN treatment combined with UC treatment while patients in the UC group will receive UC treatment alone for 4 weeks. The primary outcomes are changes of NRS at baseline, after the 1st treatment, after the final treatment and 4 weeks after the final treatment. Secondary measurements will be changes of Fugl-Meyer score, constant score, MPQ-SF score, quality of life score, and range of motion at baseline, after the final treatment, and 4 weeks after the final treatment. The safety will also be assessed by monitoring the incidence of adverse events and changes in vital signs during the study.
Results from this trial will significantly support the application of FSN in the recovery of patients with HSP. If found to be effective and safe, FSN will be a valuable complementary option for patients with HSP.
Chinese Clinical Trial Registry: ChiCTR1900021644 (registered on March 2, 2019).
偏瘫性肩痛（HSP）是中风后常见的并发症，会限制患者患侧手臂的身体功能，进而影响其生活质量。浮针疗法（FSN）在中国已广泛应用于疼痛性疾病的治疗；然而，其治疗HSP的疗效和安全性仍有待阐明。因此，我们进行了一项随机对照试验，以总结目前关于浮针疗法对HSP中风幸存者恢复结局影响的证据。
在此，我们进行一项随机、双盲、对照研究的设计和方案，以评估浮针疗法治疗HSP患者的疗效和安全性。试验将招募60名数字评分量表（NRS）得分高于1的患者，并随机分为浮针疗法组或常规护理（UC）组。浮针疗法组患者将接受浮针疗法联合常规护理治疗，而常规护理组患者将仅接受常规护理治疗，为期4周。主要结局指标为基线时、首次治疗后、末次治疗后以及末次治疗后4周时NRS的变化。次要测量指标将包括Fugl-Meyer评分、Constant评分、简化 McGill 疼痛问卷（MPQ-SF）评分、生活质量评分以及基线时、末次治疗后以及末次治疗后4周时的关节活动范围。还将通过监测研究期间不良事件的发生率和生命体征变化来评估安全性。
该试验结果将有力支持浮针疗法在HSP患者康复中的应用。如果被证明有效且安全，浮针疗法将成为HSP患者有价值的辅助治疗选择。
中国临床试验注册中心：ChiCTR1900021644（于2019年3月2日注册）。
