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跟腱病的线聚焦和点聚焦体外冲击波治疗:一项安慰剂对照 RCT 研究。

Line- and Point-Focused Extracorporeal Shock Wave Therapy for Achilles Tendinopathy: A Placebo-Controlled RCT Study.

机构信息

Department of Orthopaedic Surgery, RWTH Aachen University Clinic, Aachen, Germany.

Department of Radiology, RWTH Aachen University Clinic, Aachen, Germany.

出版信息

Sports Health. 2021 Sep-Oct;13(5):511-518. doi: 10.1177/1941738121991791. Epub 2021 Feb 13.

DOI:10.1177/1941738121991791
PMID:33586526
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8404720/
Abstract

BACKGROUND

Extracorporeal shock wave therapy (ESWT) is a widely considered treatment option for Achilles tendinopathy. Line-focused ESWT is a novel technique treating a larger tendon area than point-focused ESWT. Monitoring capacities of clinical symptoms with ultrasound under ESWT treatment are unknown.

HYPOTHESIS

Point- and line-focused ESWT have a superior outcome than placebo ESWT. ESWT leads to morphological tendon changes detectable with ultrasound.

STUDY DESIGN

Single-blinded placebo-controlled randomized contolled trial.

LEVEL OF EVIDENCE

Level 1.

METHODS

The study was conducted in 3 cohorts, namely ESWT point (n = 21), ESWT line (n = 24), and ESWT placebo (n = 21). Victorian Institute of Sports Assessment-Achilles (VISA-A) score was measured before the intervention (T0), after 6 weeks (T1), and after 24 weeks (T2). All cohorts performed daily physiotherapy for 24 weeks and received 4 sessions of point-focused, line-focused, or placebo ESWT in the first 6 weeks. Ultrasound was performed with B-mode, power Doppler, shear wave elastography (SWE) at T0 and T2 and with ultrasound tissue characterization (UTC) at T0, T1, and T2. Data were analyzed with a mixed analysis of variance and test.

RESULTS

There was a significant VISA-A improvement over time for all groups ( < 0.001). ESWT point had the strongest VISA-A score improvement +23 (ESWT line: +18; ESWT placebo: +15), but there was no significant interaction between time and any of the groups: (4, 116) = 1.393; = 0.24. UTC, power Doppler, and B-mode could not show significant alterations over time. SWE revealed a significant increase of elastic properties for ESWT point in the insertion ( = -3.113, = 0.03) and midportion ( = -2.627, = 0.02) over time.

CONCLUSION

There is a significant VISA-A score improvement for all study groups without a statistically significant benefit for ESWT point or ESWT line compared with ESWT placebo. Tendon adaptation could only be detected with SWE for ESWT point.

CLINICAL RELEVANCE

The present study could not detect any statistically relevant effect of ESWT compared to placebo. SWE is able to demonstrate tendon adaptation.

摘要

背景

体外冲击波疗法(ESWT)被广泛认为是治疗跟腱病的一种治疗选择。线聚焦 ESWT 是一种新的技术,可治疗比点聚焦 ESWT 更大的肌腱区域。在 ESWT 治疗下,超声监测临床症状的能力尚不清楚。

假设

点聚焦和线聚焦 ESWT 比安慰剂 ESWT 有更好的效果。ESWT 导致可通过超声检测到的形态学肌腱变化。

研究设计

单盲安慰剂对照随机对照试验。

证据水平

1 级。

方法

该研究分为 3 个队列,即 ESWT 点(n = 21)、ESWT 线(n = 24)和 ESWT 安慰剂(n = 21)。维多利亚运动评估-跟腱(VISA-A)评分在干预前(T0)、6 周后(T1)和 24 周后(T2)进行测量。所有队列均进行 24 周的日常物理治疗,并在第 1 至 6 周接受 4 次点聚焦、线聚焦或安慰剂 ESWT。在 T0 和 T2 进行 B 模式、功率多普勒、剪切波弹性成像(SWE),在 T0、T1 和 T2 进行超声组织特征(UTC)。数据采用混合方差分析和 t 检验进行分析。

结果

所有组的 VISA-A 评分均随时间显著改善(<0.001)。ESWT 点的 VISA-A 评分改善最大(+23)(ESWT 线:+18;ESWT 安慰剂:+15),但时间与任何一组之间均无显著交互作用:(4, 116)= 1.393;= 0.24。UTC、功率多普勒和 B 模式在随时间的变化中均不能显示出显著的变化。SWE 显示 ESWT 点在插入部位(= -3.113,= 0.03)和中段(= -2.627,= 0.02)的弹性特性随时间显著增加。

结论

所有研究组的 VISA-A 评分均有显著改善,与 ESWT 安慰剂相比,ESWT 点或 ESWT 线没有统计学上的益处。只有 SWE 能够检测到 ESWT 点的肌腱适应。

临床意义

本研究未能检测到 ESWT 与安慰剂相比的任何统计学相关效应。SWE 能够显示肌腱适应。

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