The First Affiliated Hospital of Guangzhou University of Chinese Medicine, No.12 Ji Chang Road, Baiyun District, Guangzhou, 510405, China.
Guangzhou University of Chinese Medicine, No.12 Ji Chang Road, Baiyun District, Guangzhou, 510405, China.
Trials. 2020 Feb 6;21(1):143. doi: 10.1186/s13063-019-4012-1.
Thunder-fire moxibustion originated in China and contains traditional Chinese medicine. It can produce strong firepower, infrared thermal radiation, and medicinal effects when burning on the acupoints. Thunder-fire moxibustion is commonly used in patients with neck pain, but its efficacy has rarely been systematically demonstrated. We designed a randomized trial of thunder-fire moxibustion on cervical spondylotic radiculopathy (CSR) to investigate whether it is more effective than ibuprofen sustained-release capsules.
One hundred patients will be recruited and randomly divided into thunder-fire moxibustion and ibuprofen groups. The intervention consists of ten treatments and will last for 2 weeks. The Yasuhisa Tanaka 20 Score Scale is used as the primary outcome measure. It contains a combination of the self-conscious symptom in patients, objective clinical evaluation from doctors, and social evaluation (the ability to work and live). The objective and comprehensive evaluation of CSR patients before and after treatment is particularly needed. The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2), Neck Disability Index score scale (NDI), and the Quality of Life Assessment (SF-36) are applied as secondary outcome measures. The assessment will take place at the baseline and the first and second weekends of treatment. If an adverse event (AEs) occurs, it will be reported.
The aim of this trial is to determine whether thunder-fire moxibustion is more effective than ibuprofen in the treatment of patients with CSR.
Chinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR1800018820. Registered on 11 October 2018.
雷火灸源于中国，包含中药。它在穴位燃烧时能产生强大的火力、红外热辐射和药效。雷火灸常用于治疗颈痛患者，但它的疗效很少得到系统证实。我们设计了一项雷火灸治疗神经根型颈椎病（CSR）的随机试验，以探讨它是否比布洛芬缓释胶囊更有效。
将招募 100 名患者，并随机分为雷火灸组和布洛芬组。干预措施包括 10 次治疗，持续 2 周。用田中雅敏 20 分量表作为主要结局指标。它包含了患者自觉症状、医生客观临床评估和社会评估（工作和生活能力）的综合。治疗前后 CSR 患者的客观综合评估尤其需要。我们还应用简明 McGill 疼痛问卷-2（SF-MPQ-2）、颈部残疾指数评分量表（NDI）和生活质量评估（SF-36）作为次要结局指标。评估将在基线、治疗的第一和第二个周末进行。如果发生不良事件（AEs），将进行报告。
本试验旨在确定雷火灸在 CSR 患者治疗中的疗效是否优于布洛芬。
中国临床试验注册中心（http://www.chictr.org.cn），ChiCTR1800018820。注册于 2018 年 10 月 11 日。
