Kim Doori, Lee Yoon Jae, Park Kyoung Sun, Kim Suna, Seo Ji-Yeon, Cho Hyun Woo, Ha In-Hyuk
Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation.
Jaseng Hospital of Korean Medicine, Gangnam-gu, Seoul.
Medicine (Baltimore). 2020 Oct 30;99(44):e22871. doi: 10.1097/MD.0000000000022871.
Neck pain is a common complaint in the general population. Despite the consistent ongoing pain and the resulting economic burden on affected individuals, there have only been a few studies investigating the treatment of acute neck pain. This study aims to evaluate the effectiveness, safety, and cost-effectiveness of the motion style acupuncture treatment (MSAT) and acupuncture treatment for acute neck pain.
This 2-armed, parallel, multi-centered randomized controlled trial will be conducted at 4 community-based hospitals in Korea. A total of 128 subjects will be randomly assigned, at a 1:1 ratio, to the MSAT and the acupuncture treatment groups. Treatment will be administered 2 to 3 times a week for 2 weeks. The primary outcome will be the visual analog scale of neck pain on movement. The secondary outcomes will be the numeric rating scale of the neck, neck disability index, Northwick Park questionnaire, patient global impression of change, range of motion of the neck, 5-level EuroQol-5 dimension, 12-item Short-Form Health Survey, and EuroQol visual analogue scale. This protocol has been registered at the Clinicaltrials.gov (NCT04539184).
To our knowledge, this study is the first well-designed multi-centered randomized controlled trial to evaluate the effectiveness, safety, and cost-effectiveness of MSAT on acute neck pain. The results of this study will be useful for clinicians in primary medical institutions that frequently treat acute neck pain patients and for policymakers working with national health insurance.
颈部疼痛是普通人群中的常见主诉。尽管持续存在疼痛并给患者带来经济负担，但针对急性颈部疼痛治疗的研究却为数不多。本研究旨在评估运动式针刺疗法（MSAT）和针刺疗法治疗急性颈部疼痛的有效性、安全性和成本效益。
这项双臂、平行、多中心随机对照试验将在韩国的4家社区医院进行。总共128名受试者将按1:1的比例随机分配到MSAT组和针刺治疗组。治疗将每周进行2至3次，持续2周。主要结局指标将是颈部运动时疼痛的视觉模拟量表。次要结局指标将包括颈部数字评定量表、颈部残疾指数、诺斯威克公园问卷、患者总体变化印象、颈部活动范围、5维度欧洲生活质量量表、12项简明健康调查问卷以及欧洲生活质量视觉模拟量表。本方案已在Clinicaltrials.gov（NCT04539184）注册。
据我们所知，本研究是第一项精心设计的多中心随机对照试验，旨在评估MSAT治疗急性颈部疼痛的有效性、安全性和成本效益。本研究结果将对经常治疗急性颈部疼痛患者的基层医疗机构临床医生以及参与国家医疗保险工作的政策制定者有用。
