Kim Du Hwan, Park Myung Woo, Shin Hyun Iee, Lee Byung Chan, Kim Don-Kyu, Cho Chul-Hyun, Kim Ye-Ji
Department of Physical Medicine and Rehabilitation, College of Medicine, Chung-Ang University, Seoul, Republic of Korea.
Department of Orthopedic Surgery, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, Republic of Korea.
BMC Musculoskelet Disord. 2025 Jan 3;26(1):11. doi: 10.1186/s12891-024-08266-4.
Human placental hydrolysate (hPH) contains anti-inflammatory substances. This study aimed to analyze whether injecting hPH into the subacromial space could reduce pain in patients with shoulder impingement syndrome.
This single-blind, randomized controlled study enrolled 50 patients with shoulder impingement syndrome who were randomly assigned to either the hPH or placebo groups. All patients received three ultrasound-guided subacromial space injections of 4 mL hPH or normal saline every week. Outcome measurements included the Visual Analog Scale (VAS) score during daily activity, Shoulder Pain and Disability Index (SPADI), and EuroQoL 5-Dimension 5-Level (EQ-5D-5L) utility index. Patients were followed up for nine weeks after the last injection.
Significant differences were noted in the VAS (p < 0.001) during daily activity, SPADI total score (p < 0.001), and EQ-5D-5L utility index (p < 0.001) nine weeks after the last injection between the hPH group and placebo group. Significant time effects were observed for all outcome measurements (all p < 0.001) in the hPH group but not in the placebo group. No severe complications, such as local infections or laboratory abnormalities, were reported during this study.
Subacromial injections showed significant improvement in pain, functional level, and quality of life in patients with shoulder impingement syndrome. Therefore, hPH can be used as an alternative treatment for shoulder impingement syndrome.
The trial was registered on www.
gov (NCT05528705, Registration Date: 06/09/2022).
人胎盘水解物（hPH）含有抗炎物质。本研究旨在分析将hPH注入肩峰下间隙是否能减轻肩峰撞击综合征患者的疼痛。
本单盲、随机对照研究纳入了50例肩峰撞击综合征患者，他们被随机分配到hPH组或安慰剂组。所有患者每周接受3次超声引导下肩峰下间隙注射4 mL hPH或生理盐水。观察指标包括日常活动中的视觉模拟评分（VAS）、肩痛和功能障碍指数（SPADI）以及欧洲五维健康量表（EQ-5D-5L）效用指数。在最后一次注射后对患者进行9周的随访。
最后一次注射9周后，hPH组与安慰剂组在日常活动中的VAS（p < 0.001）、SPADI总分（p < 0.001）和EQ-5D-5L效用指数（p < 0.001）方面存在显著差异。hPH组所有观察指标均观察到显著的时间效应（所有p < 0.001），而安慰剂组未观察到。本研究期间未报告严重并发症，如局部感染或实验室异常。
肩峰下注射对肩峰撞击综合征患者的疼痛、功能水平和生活质量有显著改善。因此，hPH可作为肩峰撞击综合征的替代治疗方法。
