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聚焦式冲击波疗法与放射状冲击波疗法治疗非钙化性肩袖肌腱病的疗效比较:一项随机临床试验。

Effectiveness of Focused Shockwave Therapy versus Radial Shockwave Therapy for Noncalcific Rotator Cuff Tendinopathies: A Randomized Clinical Trial.

机构信息

Department of Orthopedics, Peking University China-Japan Friendship School of Clinical Medicine, 2 Yinghuadong Road, Chaoyang District, Beijing 100029, China.

Department of Orthopedics, Graduate School of Peking Union Medical College, China-Japan Friendship Institute of Clinical Medicine, 2 Yinghuadong Road, Chaoyang District, Beijing 100029, China.

出版信息

Biomed Res Int. 2021 Jan 9;2021:6687094. doi: 10.1155/2021/6687094. eCollection 2021.

Abstract

BACKGROUND

The superiority of focused shockwave therapy (F-SWT) versus radial shockwave therapy (R-SWT) for treating noncalcific rotator cuff tendinopathies remains controversial. This study is aimed at comparing the effectiveness of F-SWT versus R-SWT for the management of noncalcific rotator cuff tendinopathies.

METHODS

A total of 46 patients affected by noncalcific rotator cuff tendinopathies were randomly divided into 2 groups of 23 individuals. Patients in group A received 4 sessions of F-SWT, while patients in group B were treated by 4 sessions of R-SWT. In each session, mean energy flux density (EFD) for F-SW 3000 shots was 0.09 ± 0.018 mJ/mm with 5.1 ± 0.5 Hz, while average pressure for R-SW 3000 shots was 4.0 ± 0.35 bar with 3.2 ± 0.0 Hz. Pain level and shoulder function were assessed with the numerical rating scale (NRS) and Constant-Murley Scale (CMS). The primary endpoint was the change in the mean NRS pain score from baseline to 24 weeks after the intervention. Secondary endpoints were changes in the mean NRS pain scores at all other follow-up points, changes in the mean CMS scores, and radiographic findings.

RESULTS

There were no significant differences between the two groups regarding NRS pain score and CMS score within 24 weeks after intervention (all > 0.05). However, F-SWT resulted in significantly lower NRS compared with R-SWT at 24 weeks and 48 weeks after treatment (2.7 ± 1.0 vs. 4.5 ± 1.2 and 1.4 ± 1.0 vs. 3.0 ± 0.8, respectively, all < 0.001). Similar results were found in CMS changes and radiographic findings.

CONCLUSIONS

Both F-SWT and R-SWT are effective in patients with noncalcific rotator cuff tendinopathy. F-SWT proved to be significantly superior to R-SWT at long-term follow-up (more than 24 weeks). This trial is registered with ChiCTR1900022932.

摘要

背景

聚焦式冲击波疗法(F-SWT)与放射式冲击波疗法(R-SWT)治疗非钙化肩袖肌腱病的优势仍存在争议。本研究旨在比较 F-SWT 与 R-SWT 治疗非钙化肩袖肌腱病的疗效。

方法

共 46 例非钙化肩袖肌腱病患者被随机分为 2 组,每组 23 例。A 组患者接受 4 次 F-SWT,B 组患者接受 4 次 R-SWT。在每次治疗中,F-SW 3000 次的平均能量通量密度(EFD)为 0.09±0.018mJ/mm,频率为 5.1±0.5Hz,R-SW 3000 次的平均压力为 4.0±0.35bar,频率为 3.2±0.0Hz。采用数字评分量表(NRS)和 Constant-Murley 评分(CMS)评估疼痛程度和肩部功能。主要终点为干预后 24 周时平均 NRS 疼痛评分的变化。次要终点为所有其他随访点的平均 NRS 疼痛评分变化、平均 CMS 评分变化和影像学发现。

结果

干预后 24 周内,两组 NRS 疼痛评分和 CMS 评分均无显著差异(均>0.05)。然而,F-SWT 在治疗后 24 周和 48 周时的 NRS 评分明显低于 R-SWT(分别为 2.7±1.0 比 4.5±1.2 和 1.4±1.0 比 3.0±0.8,均<0.001)。CMS 评分变化和影像学发现也有类似结果。

结论

F-SWT 和 R-SWT 均能有效治疗非钙化肩袖肌腱病。在长期随访(超过 24 周)中,F-SWT 明显优于 R-SWT。本试验在中国临床试验注册中心注册,注册号为 ChiCTR1900022932。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5569/7811429/36d047febe9b/BMRI2021-6687094.001.jpg

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