Wu Pin, Zhu Lu, Zheng Shi-Yu, Li Jun-Xiong, Wu Meng-Die, Wang Wen-Jia, Hou Yu-Chao, Li Jing, Wu Huan-Gan
Department of Acupuncture, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Department of Key Laboratory of Acupuncture and Immunological Effects, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
J Pain Res. 2022 Jul 6;15:1889-1896. doi: 10.2147/JPR.S361821. eCollection 2022.
Cancer-related pain is one of the primary symptoms of patients with hepatocellular carcinoma (HCC). Previous studies have shown that transcutaneous electrical acupoint stimulation (TEAS) is effective in treating patients with acute or chronic pain. In China, it is indispensable to evaluate the efficacy of TEAS in combination with opioids for the treatment of moderate to severe HCC-related pain.
METHODS/DESIGN: This is a single-center clinical, prospective randomized controlled clinical trial protocol. 104 patients will be randomly divided into the observation group and the control group in a ratio of 1:1.In addition to routine cancer pain medication, the two groups of patients will receive TEAS treatment twice a day for one week. Acupoints will include bilateral Hegu(LI4), Neiguan(PC6), Zusanli(ST36), Taichong(LR3), Ganshu(BL18), Geshu(BL17), Qimen(LR14), and Zhangmen(LR13). The treatment time is from 9:00 a.m. to 11:00 p.m. and from 4:00 p.m. to 6:00 p.m. The primary outcome measures are the Numerical Rating Scale (NRS) and the secondary outcome measures include the Brief Pain Inventory(BPI), dosage and administration duration of opioid drugs, frequency of nausea, vomiting and defecation, Karnofsky Performance Status Scale (KPS), Quality of life scale (QOL), Brief Fatigue Inventory (BFI). The outcome measures will be evaluated at baseline, during treatment and 1 week after treatment.
Results of this trial are expected to clarify the value of TEAS stimulation performed on specific points in the management of moderate to severe pain in HCC.
Chinese clinical trial registry, ChiCTR2100044615 (http://www.chictr.org.cn), Registered on 24 March 2021.
癌痛是肝细胞癌(HCC)患者的主要症状之一。既往研究表明,经皮穴位电刺激(TEAS)对急慢性疼痛患者有效。在中国,评估TEAS联合阿片类药物治疗中度至重度HCC相关疼痛的疗效至关重要。
方法/设计:这是一项单中心临床前瞻性随机对照临床试验方案。104例患者将按1:1的比例随机分为观察组和对照组。除常规癌痛药物治疗外,两组患者均接受TEAS治疗,每日2次,共1周。穴位包括双侧合谷(LI4)、内关(PC6)、足三里(ST36)、太冲(LR3)、肝俞(BL18)、膈俞(BL17)、期门(LR14)和章门(LR13)。治疗时间为上午9:00至11:00以及下午4:00至6:00。主要结局指标为数字评分量表(NRS),次要结局指标包括简明疼痛问卷(BPI)、阿片类药物的剂量和使用时长、恶心、呕吐及排便频率、卡氏功能状态量表(KPS)、生活质量量表(QOL)、简明疲劳量表(BFI)。结局指标将在基线、治疗期间及治疗后1周进行评估。
本试验结果有望阐明在特定穴位进行TEAS刺激对HCC中度至重度疼痛管理的价值。
中国临床试验注册中心,ChiCTR2100044615(http://www.chictr.org.cn),于2021年3月24日注册。