Li Tian, Wang Siyao, Zhang Shen, Shen Xueyong, Song Yanwen, Yang Zhen, Huang Zouqin
Shanghai Pudong New Area Hospital of Traditional Chinese Medicine, 399 Pingchuan Road, Pudong New Area, Shanghai, 201299, China.
Trials. 2019 Jul 31;20(1):470. doi: 10.1186/s13063-019-3566-2.
As a common cause of low back pain, lumbosacral disc herniation (LDH) is usually dealt with using non-surgical interventions. In the face of concerns about prescription opioid abuse, alternative and complementary treatments may be promising, among which silver-needle warm acupuncture is considered as an upgrading option for its potential anti-inflammatory and strong analgesic effect for patients with chronic pain. In this proposed study, we aim to assess its clinical efficacy in comparison with conventional stainless steel filiform-needle warm acupuncture.
METHODS/DESIGN: This is a randomized, two-armed, patient- and assessor-blinded trial. One hundred and sixty eligible patients recruited from December 2018 to June 2020 in three centers will be assigned for warm acupuncture treatment with either stainless steel filiform or silver needles. Nine sessions of 20-min treatment will be conducted during 3 consecutive weeks. Assessments with instruments including the Oswestry Disability Index, the visual analog scale, and the Japanese Orthopedic Association Back Pain Evaluation Questionnaire will be performed at four time points to explore the difference of clinical efficacy between two groups.
If the results show that participants treated with silver-needle warm acupuncture gain a greater improvement in terms of pain intensity, physical function, and quality of life, this study is expected to offer reliable evidence to widely push this treatment for LDH in clinical practice.
Chinese Clinical Trial Registry, ChiCTR1800019051 . Registered on 24 October 2018.
作为腰痛的常见原因，腰骶部椎间盘突出症（LDH）通常采用非手术干预措施进行治疗。鉴于对处方阿片类药物滥用的担忧，替代疗法和补充疗法可能具有前景，其中银质针温针灸因其对慢性疼痛患者潜在的抗炎和强效镇痛作用而被视为一种升级选择。在本拟进行的研究中，我们旨在评估其与传统不锈钢毫针温针灸相比的临床疗效。
方法/设计：这是一项随机、双臂、患者和评估者双盲试验。2018年12月至2020年6月在三个中心招募的160名符合条件的患者将被分配接受不锈钢毫针或银质针温针灸治疗。在连续3周内进行9次每次20分钟的治疗。将在四个时间点使用包括Oswestry功能障碍指数、视觉模拟量表和日本骨科学会腰痛评估问卷在内的工具进行评估，以探讨两组之间临床疗效的差异。
如果结果表明接受银质针温针灸治疗的参与者在疼痛强度、身体功能和生活质量方面有更大改善，本研究有望提供可靠证据，以在临床实践中广泛推广这种针对LDH的治疗方法。
中国临床试验注册中心，ChiCTR1800019051。于2018年10月24日注册。
