Park Kyoung Sun, Kim Suna, Seo Ji Yeon, Cho HyunWoo, Lee Jee Young, Lee Yoon Jae, Lee Jinho, Kim Min Ji, Choi Young Eun, Yang Chang Sop, Han Chang-Hyun, Ha In-Hyuk
Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea.
Daejeon Jaseng Hospital of Korean Medicine, Daejeon, Republic of Korea.
J Pain Res. 2022 Sep 1;15:2629-2639. doi: 10.2147/JPR.S375231. eCollection 2022.
Chronic low back pain (LBP) is a common musculoskeletal disorder that affects everyday life; moreover, it occasionally causes disability and increases medical expenditure. This pragmatic randomized clinical trial aims to investigate the effects of pharmacopuncture on chronic LBP by comparing the effectiveness of pharmacopuncture and physiotherapy strategies.
In this two-armed, parallel, multi-center randomized controlled study, the participants will randomly undergo 10 sessions of pharmacopuncture therapy or physiotherapy over five weeks based on the randomization outcomes. The primary outcome will be the numeric rating scale (NRS) score of LBP. The secondary outcomes will include the NRS score of radiating leg pain, visual analog scale (VAS) score of LBP and radiating leg pain, Oswestry disability index, the Korean version of the Roland-Morris disability questionnaire, patient global impression of change (PGIC), short Form-12 health survey version 2, and 5-level EuroQol-5 dimension (EQ-5D-5L).
This protocol aims to examine the comparative effectiveness of pharmacopuncture, which is a widely used therapy in Korean medicine, with respect to the standard therapy through a pragmatic randomized controlled trial to present useful data to facilitate clinical or policy decision making.
Clinicaltrials.gov (NCT04833309); Clinical Research Information Service (KCT0006088).
慢性下腰痛（LBP）是一种常见的肌肉骨骼疾病，会影响日常生活；此外，它偶尔会导致残疾并增加医疗费用。这项实用的随机临床试验旨在通过比较药物针灸和物理治疗策略的有效性，研究药物针灸对慢性下腰痛的影响。
在这项双臂、平行、多中心随机对照研究中，参与者将根据随机分组结果在五周内随机接受10次药物针灸治疗或物理治疗。主要结局将是下腰痛的数字评分量表（NRS）得分。次要结局将包括放射痛的NRS得分、下腰痛和放射痛的视觉模拟量表（VAS）得分、Oswestry功能障碍指数、韩国版罗兰-莫里斯功能障碍问卷、患者总体变化印象（PGIC）、简明健康调查简表第2版以及5级欧洲五维健康量表（EQ-5D-5L）。
本方案旨在通过实用的随机对照试验，检验韩国医学中广泛使用的药物针灸相对于标准治疗的比较有效性，以提供有用数据，促进临床或政策决策。
Clinicaltrials.gov（NCT04833309）；韩国临床研究信息服务中心（KCT0006088）。
