Kim Doori, Park Kyoung Sun, Kim Sun-A, Seo Ji Yeon, Cho Hyun-Woo, Lee Yoon Jae, Yang Changsop, Ha In-Hyuk, Han Chang-Hyun
Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.
Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea.
Integr Med Res. 2024 Sep;13(3):101065. doi: 10.1016/j.imr.2024.101065. Epub 2024 Jun 21.
Although several studies have reported the effectiveness of acupuncture treatment for adhesive capsulitis (AC), research on pharmacopuncture therapy for AC remains limited. We compared the effectiveness and safety of pharmacopuncture and physiotherapy for AC.
This pragmatic, randomized, controlled, parallel-group pilot study enrolled patients with limitations of shoulder movement and a numeric rating scale (NRS) score for shoulder pain ≥5 randomized (1:1) to the pharmacopuncture therapy (PPT) and physiotherapy (PT) groups. Treatment sessions were administered twice weekly for 6 weeks, and the participants were followed up for 13 weeks after randomization. The primary outcome was the NRS score for shoulder pain, and the secondary outcomes were the visual analog scale (VAS), Shoulder Pain and Disability Index (SPADI), range of motion (ROM), patient global impression of change (PGIC), EuroQol 5-Dimension 5-Level (EQ-5D-5L), and Short Form 12 Health Survey (SF-12) scores. The intention-to-treat (ITT) analysis was set as the primary analysis.
Among 50 participants, for the primary endpoint (week 7) the PPT group showed a significantly superior improvement in NRS, VAS, SPADI, ROM for flexion, ROM for abduction, and EQ-5D-5L scores. The ROM for extension, ROM for adduction, physical component summary, and patient global impression of change were significantly better in the PPT than in the PT group, and these effects were sustained until week 13.
In this pilot study, PPT showed better effects than PT, confirming the feasibility of a follow-up main study.
Clinicaltrials.gov (NCT05292482) and cris.nih.go.kr (KCT0007198).
尽管多项研究报告了针刺治疗肩周炎（AC）的有效性，但关于药物穴位注射疗法治疗AC的研究仍然有限。我们比较了药物穴位注射和物理治疗对AC的有效性和安全性。
这项实用、随机、对照、平行组的试点研究纳入了肩部活动受限且肩部疼痛数字评定量表（NRS）评分≥5的患者，将其随机（1:1）分为药物穴位注射疗法（PPT）组和物理治疗（PT）组。治疗每周进行两次，共6周，随机分组后对参与者进行13周的随访。主要结局是肩部疼痛的NRS评分，次要结局包括视觉模拟量表（VAS）、肩部疼痛和功能障碍指数（SPADI）、活动范围（ROM）、患者总体变化印象（PGIC）、欧洲五维健康量表（EQ-5D-5L）和简明健康调查量表（SF-12）评分。意向性分析（ITT）被设定为主要分析方法。
在50名参与者中，对于主要终点（第7周），PPT组在NRS、VAS、SPADI、前屈ROM、外展ROM和EQ-5D-5L评分方面显示出显著更好的改善。PPT组的后伸ROM、内收ROM、身体成分总结和患者总体变化印象明显优于PT组，并且这些效果持续到第13周。
在这项试点研究中，PPT显示出比PT更好的效果，证实了后续主要研究的可行性。
Clinicaltrials.gov（NCT05292482）和cris.nih.go.kr（KCT0007198）。
