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一项双盲、随机、假对照临床试验,旨在评估一种新型压电体外冲击波装置在胫骨平台后外侧稳定术(TPLO)后的疗效。

Blinded, randomized, sham-controlled clinical trial assessing the efficacy of a novel piezoelectric extracorporeal shockwave device following TPLO.

作者信息

Campbell Shannon L, Franklin Ashley L, Franklin Samuel P

机构信息

Kansas City Canine Orthopedics, Shawnee, KS, United States.

出版信息

Front Vet Sci. 2025 Jul 24;12:1600116. doi: 10.3389/fvets.2025.1600116. eCollection 2025.

Abstract

INTRODUCTION

Extracorporeal shockwave therapy (ESWT) devices have been used to effectively treat a wide variety of musculoskeletal conditions in veterinary medicine. However, several factors have limited ESWT device adoption, including that they are commonly loud, uncomfortable, and application typically requires sedation or anesthesia. A novel piezoelectric ESWT device has been developed which is lightweight, quiet, and does not require sedation for application. The purpose of this study is to assess the safety and efficacy of this novel device in clinical application.

MATERIALS AND METHODS

This was a prospective blinded trial in which dogs were randomly allocated to receive three ESWT treatments, or three sham treatments, immediately following and at 2 and 4 weeks post tibial plateau leveling osteotomy (TPLO). The primary outcome measure was clinical function at 4 and 8 weeks post-operatively based on objective gait analysis. Secondary outcome measures included owner subjective assessments (Canine Brief Pain Inventory and Liverpool Osteoarthritis for Dogs questionnaires) at 2, 4, and 8 weeks post-operatively and radiographic assessment of patella tendon thickness and osteotomy healing at 8 weeks post-operatively.

RESULTS

All dogs completed all ESWT treatments without the need for sedation and no adverse events associated with ESWT use were observed or reported. Dogs in the ESWT group bore significantly more weight at a trot at 4 weeks post-operatively in comparison to dogs in the sham treatment group. There were no statistically significant differences between groups based on owner subjective assessments or radiographic assessments.

DISCUSSION

The study demonstrated that the device was safe and that treatments could be completed without the need for sedation. Subjective owner assessment and radiographic bone healing were not significantly improved with treatment. However, the primary outcome measure, objective gait analysis using a pressure sensitive walkway, showed that dogs in the treatment group bore significantly more weight 4 weeks post-operatively at a trot in comparison to sham-treated dogs.

摘要

引言

体外冲击波疗法(ESWT)设备已被用于有效治疗兽医学中多种肌肉骨骼疾病。然而,有几个因素限制了ESWT设备的应用,包括它们通常噪音大、让人不舒服,而且应用时通常需要镇静或麻醉。一种新型压电ESWT设备已被研发出来,它重量轻、安静,应用时不需要镇静。本研究的目的是评估这种新型设备在临床应用中的安全性和有效性。

材料与方法

这是一项前瞻性双盲试验,将犬随机分配,在胫骨平台水平截骨术(TPLO)后立即以及术后2周和4周接受三次ESWT治疗或三次假治疗。主要结局指标是基于客观步态分析的术后4周和8周的临床功能。次要结局指标包括术后2周、4周和8周时主人的主观评估(犬简短疼痛量表和犬类利物浦骨关节炎问卷),以及术后8周时髌腱厚度和截骨愈合情况的影像学评估。

结果

所有犬均在无需镇静的情况下完成了所有ESWT治疗,未观察到或报告与ESWT使用相关的不良事件。与假治疗组的犬相比,ESWT组的犬在术后4周小跑时负重明显更多。基于主人主观评估或影像学评估,两组之间没有统计学上的显著差异。

讨论

该研究表明该设备是安全且治疗无需镇静即可完成。治疗后主人的主观评估和影像学骨愈合情况没有显著改善。然而,主要结局指标,即使用压力敏感通道进行的客观步态分析显示,与假治疗的犬相比,治疗组的犬在术后4周小跑时负重明显更多。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7db0/12330287/76d711851927/fvets-12-1600116-g0001.jpg

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