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超声引导下针刺联合肩峰下皮质类固醇注射与高能体外冲击波治疗肩袖钙化性肌腱炎的随机对照研究。

Comparing Ultrasound-Guided Needling Combined With a Subacromial Corticosteroid Injection Versus High-Energy Extracorporeal Shockwave Therapy for Calcific Tendinitis of the Rotator Cuff: A Randomized Controlled Trial.

机构信息

Department of Orthopaedic Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands.

Department of Orthopaedic Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands.

出版信息

Arthroscopy. 2020 Jul;36(7):1823-1833.e1. doi: 10.1016/j.arthro.2020.02.027. Epub 2020 Feb 28.

DOI:10.1016/j.arthro.2020.02.027
PMID:32114063
Abstract

PURPOSE

To compare clinical and radiographic outcomes after treatment with standardized high-energy extracorporeal shock wave therapy (ESWT) and ultrasound-guided needling (UGN) in patients with symptomatic calcific tendinitis of the rotator cuff who were nonresponsive to conservative treatment.

METHODS

The study was designed as a randomized controlled trial. The ESWT group received ESWT (2000 pulses, energy flux density 0.35 mJ/mm) in 4 sessions with 1-week intervals. UGN was combined with a corticosteroid ultrasound-guided subacromial bursa injection. Shoulder function was assessed at standardized follow-up intervals (6 weeks and 3, 6, and 12 months) using the Constant Murley Score (CMS), the Disabilities of the Arm, Shoulder, and Hand questionnaire, and visual analog scale for pain and satisfaction. The size, location, and morphology of the deposits were evaluated on radiographs. The a priori sample size calculation computed that 44 participants randomized in each treatment group was required to achieve a power of 80%.

RESULTS

Eighty-two patients were treated (56 female, 65%; mean age 52.1 ± 9 years) with a mean baseline CMS of 66.8 ± 12 and mean calcification size of 15.1 ± 4.7 mm. One patient was lost to follow-up. At 1-year follow-up, the UGN group showed similar results as the ESWT group with regard to the change from baseline CMS (20.9 vs 15.7; P = .23), Disabilities of the Arm, Shoulder, and Hand questionnaire (-20.1 vs -20.7; P = .78), and visual analog scale for pain (-3.9 and -2.6; P = .12). The mean calcification size decreased by 13 ± 3.9 mm in the UGN group and 6.7 ± 8.2 mm in the ESWT group (<P = .001). In total, 22% of the UGN and 41% of the ESWT patients received an additional treatment during follow-up because of persistent symptoms.

CONCLUSIONS

This RCT compares the clinical and radiographic results of UGN and high-energy ESWT in the treatment of calcific tendinitis of the rotator cuff. Both techniques are successful in improving function and pain, with high satisfaction rates after 1-year follow-up. However, UGN is more effective in eliminating the calcific deposit, and the amount of additional treatments was greater in the ESWT group.

LEVEL OF EVIDENCE

II, randomized controlled trial.

摘要

目的

比较标准化高能体外冲击波治疗(ESWT)和超声引导下针刺(UGN)治疗对经保守治疗无效的肩袖症状性钙化性肌腱炎患者的临床和影像学结果。

方法

本研究设计为随机对照试验。ESWT 组接受 ESWT(2000 脉冲,能量通量密度 0.35 mJ/mm),4 次,间隔 1 周。UGN 结合皮质类固醇超声引导下肩峰下囊注射。在标准化随访间隔(6 周和 3、6 和 12 个月)使用 Constant-Murley 评分(CMS)、手臂、肩和手残疾问卷和疼痛及满意度视觉模拟评分评估肩部功能。在放射影像上评估沉积物的大小、位置和形态。根据预先计算的样本量,每组 44 名随机分组的患者需要达到 80%的效能。

结果

82 例患者接受治疗(56 例女性,65%;平均年龄 52.1±9 岁),基线 CMS 平均为 66.8±12,钙化平均大小为 15.1±4.7mm。1 例患者失访。在 1 年随访时,UGN 组与 ESWT 组在基线 CMS 变化方面的结果相似(20.9 对 15.7;P=0.23),手臂、肩和手残疾问卷(-20.1 对-20.7;P=0.78)和疼痛视觉模拟评分(-3.9 对-2.6;P=0.12)。UGN 组钙化平均大小减少 13±3.9mm,ESWT 组减少 6.7±8.2mm(P<0.001)。在整个随访过程中,UGN 组有 22%的患者和 ESWT 组有 41%的患者因持续症状而接受了额外的治疗。

结论

这项 RCT 比较了 UGN 和高能 ESWT 治疗肩袖钙化性肌腱炎的临床和影像学结果。两种技术都能成功改善功能和疼痛,1 年后随访满意度高。然而,UGN 在消除钙化沉积物方面更有效,ESWT 组的额外治疗量更大。

证据水平

II 级,随机对照试验。

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