UNASSIGNED: This study aims to assess the effectiveness and safety of pharmacopuncture for rotator cuff disease.
UNASSIGNED: A two-group, parallel, single-center, pragmatic, randomized, controlled, assessor-blinded trial will be conducted. A total of 40 patients will be recruited, starting in July 2022. All patients will be received acupuncture treatment, and pharmacopuncture will be applied to intervention group additionally. After eight treatments are delivered over four weeks, follow-up assessments will be performed.
UNASSIGNED: Assessments will evaluate the effectiveness and safety of these treatments at baseline and at weeks 2 (2 W), 4 (4 W), and 8 (8 W). The primary outcome will be a visual analog scale (VAS) evaluation of shoulder pain levels. Assessments will include shoulder pain and disability index (SPADI), shoulder range of motion (ROM), EuroQol 5-Dimension 5-Level (EQ-5D-5L), patient global impression of change (PGIC), \'no worse than mild pain\', and drug consumption rates.
UNASSIGNED: This study may offer a rationale for a future full-scale trial on the effectiveness and safety of pharmacopuncture treatment for rotator cuff disease and provide data on non-surgical treatment for the disease.
■本研究旨在评估药物穿刺治疗肩袖疾病的有效性和安全性。
■两组,平行,单中心,务实,随机化,控制,将进行评估者盲法试验。共招募40名患者,从2022年7月开始。所有患者都将接受针灸治疗,药物穿刺将另外应用于干预组。在四周内进行了八次治疗后,将进行后续评估。
■评估将在基线和第2周(2W)评估这些治疗的有效性和安全性,4(4W),和8(8W)。主要结果将是肩痛水平的视觉模拟量表(VAS)评估。评估将包括肩痛和残疾指数(SPADI),肩部运动范围(ROM),EuroQol5维5级(EQ-5D-5L),患者整体变化印象(PGIC),\'不比轻度疼痛更糟糕\',和药物消费率。
■这项研究可能为未来关于药物穿刺治疗肩袖疾病的有效性和安全性的全面试验提供依据,并提供非手术治疗该疾病的数据。