Kang Ha-Ra, Jung Chan-Yung, Lee Seung-Deok, Kim Kyung-Ho, Kim Kap-Sung, Kim Eun-Jung
Department of Acupuncture & Moxibustion, Dongguk University Ilsan Oriental Hospital, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea.
College of Korean Medicine, Dongguk University, Dongdae-ro, Gyeongju-si, Gyeongsangbuk-do, Republic of Korea.
Trials. 2018 Mar 5;19(1):159. doi: 10.1186/s13063-018-2514-x.
BACKGROUND: Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. METHODS: This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of "ashi", if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. DISCUSSION: This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03287570 . Registered on 19 September 2017.
背景：膝关节骨关节炎（KOA）是一个重大的健康问题，因为它会导致疼痛和功能受限。许多研究报告称，韩国传统医学中的艾灸疗法对治疗KOA有效。然而，传统艾灸会产生烟雾、有害气体和气味，可能会对眼睛、皮肤和喉咙产生不利影响。传统艾灸也难以控制刺激强度。为了解决这些问题，研发了一种电子艾灸设备，但对该设备的研究较少。我们将评估电子艾灸治疗KOA的疗效和安全性，并将其与传统间接艾灸和常规护理进行比较。 方法：这是一项多中心、随机、开放、评估者盲法、平行组临床试验。总共138名符合条件的KOA参与者将按1:1:1的比例随机分配到三组（电子艾灸、传统间接艾灸或常规护理）。每个艾灸组的参与者将在6个穴位（足三里、上巨虚、条口、阴陵泉、犊鼻、地机）接受12次艾灸治疗，如有需要，可额外选取最多2个阿是穴，为期6周（每周2次）。电子艾灸组将使用一种专门设计的利用电能提供热刺激的设备。常规护理组的参与者将接受常规治疗和自我护理。主要结局指标是从第1周到第6周数字评分量表（NRS）上疼痛的变化。次要结局指标包括视觉模拟量表（VAS）评估的疼痛、韩国版西安大略和麦克马斯特大学骨关节炎指数（K-WOMAC）、患者整体评估（PGA）以及欧洲生活质量五维度五级量表（EQ-5D-5L）。通过在每次就诊时监测不良事件来评估安全性。在基线测量后12周进行随访测量。 讨论：本试验将为电子艾灸治疗KOA的疗效和安全性提供证据。 试验注册：ClinicalTrials.gov，NCT03287570。于2017年9月19日注册。
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