Oh Seo Young, Kang Jae Hui
Department of Acupuncture and Moxibustion Medicine, Cheonan Korean Medicine Hospital of Daejeon University, Chungcheongnamdo, Republic of Korea.
Medicine (Baltimore). 2018 Nov;97(44):e13047. doi: 10.1097/MD.0000000000013047.
Chronic low back pain is one of the major conditions causing serious personal and social difficulties in modern society. There are several noninvasive therapies for chronic low back pain; however, the effects of electromagnetic acupuncture have not been studied. Here, we describe the protocol for a study that will investigate the efficacy and safety of electromagnetic acupuncture for patients with chronic low back pain.
The study has been designed as a double-blind, single-center, parallel-arm, sham-controlled, randomized clinical trial. A total of 104 patients with chronic low back pain who meet the criteria for selection and exclusion will be enrolled in a 1:1 ratio in an electromagnetic acupuncture group or a sham group. Sterilized disposable needles will be inserted at 6 acupoints, following which stimulation via an electromagnetic (Whata153) or a placebo (sham) stimulator will be applied. The 2 groups will receive a total of 6 treatment sessions over 3 weeks, with 1 follow-up visit within 3 days after the final treatment. The primary outcome will be the change in the visual analog scale (VAS) score for pain from baseline (visit 1, first treatment session) to the follow-up visit (visit 7, after treatment completion). The secondary outcomes will be as follows: changes in the VAS score for pain from baseline (visit 1) to visits 3 (third session) and 5 (fifth session); changes in the VAS score for pain at all assessment points from baseline (visit 1) to the follow-up visit (visit 7); changes in the Oswestry Disability Index (ODI) from visit 1 to visits 3, 5, and 7; and the change in ODI at all assessment points from visit 1 to visit 7.
The results of this trial are expected to provide important clinical information on the efficacy and safety of electromagnetic acupuncture for patients with chronic low back pain.
慢性腰痛是现代社会导致严重个人和社会困难的主要病症之一。慢性腰痛有多种非侵入性治疗方法；然而，电磁针刺疗法的效果尚未得到研究。在此，我们描述一项研究方案，该研究将调查电磁针刺疗法对慢性腰痛患者的疗效和安全性。
本研究设计为双盲、单中心、平行组、假对照、随机临床试验。总共104名符合入选和排除标准的慢性腰痛患者将按1:1的比例纳入电磁针刺组或假治疗组。将无菌一次性针具刺入6个穴位，随后通过电磁（Whata153）或安慰剂（假）刺激器进行刺激。两组将在3周内共接受6次治疗，在最后一次治疗后3天内进行1次随访。主要结局将是疼痛视觉模拟量表（VAS）评分从基线（第1次访视，首次治疗 session）到随访访视（第7次访视，治疗完成后）的变化。次要结局如下：疼痛VAS评分从基线（第1次访视）到第3次（第3次session）和第5次（第5次session）访视的变化；从基线（第1次访视）到随访访视（第7次访视）所有评估点的疼痛VAS评分变化；从第1次访视到第3次、第5次和第7次访视的Oswestry功能障碍指数（ODI）变化；以及从第1次访视到第7次访视所有评估点的ODI变化。
本试验结果有望为电磁针刺疗法对慢性腰痛患者的疗效和安全性提供重要临床信息。
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