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髌腱病治疗干预措施的对比研究:一项随机对照试验方案。

Comparative study of treatment interventions for patellar tendinopathy: a protocol for a randomised controlled trial.

机构信息

iPhysio Research Group, Facultad de Ciencias de la Salud. Universidad San Jorge, Villanueva de Gallego, Aragón, Spain.

Departamento de Fisiatría y Enfermería, Facultad de Ciencias de la Salud, Universidad de Zaragoza, Zaragoza, Aragón, Spain.

出版信息

BMJ Open. 2020 Feb 16;10(2):e034304. doi: 10.1136/bmjopen-2019-034304.

Abstract

INTRODUCTION

Patellar tendinopathy is a degenerative disease of the patellar tendon, which affects athletes from a variety of sports, and is especially predominant in sports involving high-impact jumping. The aim of this study is to determine the additional effect of two interventions combined with eccentric exercise and compare which one is the most effective at short-term and long-term follow-up for patients with patellar tendinopathy.

METHODS AND ANALYSIS

This study is a randomised controlled trial with blinded participants. Measurements will be carried out by a specially trained blinded assessor. A sample of 57 patients with a medical diagnosis of patellar tendinopathy will participate in this study and will be divided into three treatment groups. Eligible participants will be randomly allocated to receive either: (a) treatment group with percutaneous needle electrolysis, (b) treatment group with dry needling or (c) treatment group with placebo needling. In addition, all groups will perform eccentric exercise. Functionality and muscle strength parameters, pain, ultrasound appearances and patient perceived quality of life shall be evaluated using the Victorian Institute of Sports Assessment for patellar (VISA-P), jump tests, Visual Analogue Scale, ultrasound images and Short Form-36 (SF-36), respectively. Participants will be assessed at baseline, at 10 weeks and at 22 weeks after baseline. The expected findings will allow us to advance in the treatment of this injury, as they will help determine whether a needling intervention has additional effects on an eccentric exercise programme and whether any of the needling modalities is more effective than the other.

ETHICS AND DISSEMINATION

This protocol has been approved by the Ethics Committee of Aragon (N° PI15/0017). The trial will be conducted in accordance with the Declaration of Helsinki.

TRIAL REGISTRATION NUMBER

NCT02498795.

摘要

简介

髌腱病是髌腱的一种退行性疾病,影响多种运动的运动员,尤其是涉及高冲击跳跃的运动。本研究的目的是确定两种干预措施与离心运动相结合的附加效果,并比较哪种方法在髌腱病患者的短期和长期随访中最有效。

方法和分析

这是一项随机对照试验,参与者设盲。将由专门培训的盲法评估员进行测量。将有 57 名经医学诊断为髌腱病的患者参与本研究,并将其分为三组治疗组。符合条件的参与者将被随机分配接受以下治疗之一:(a)经皮针电解治疗组,(b)干针治疗组或(c)安慰剂针治疗组。此外,所有组都将进行离心运动。使用维多利亚运动评估髌腱(VISA-P)、跳跃测试、视觉模拟量表、超声图像和简短形式 36(SF-36)分别评估功能和肌肉力量参数、疼痛、超声表现和患者感知的生活质量。参与者将在基线、第 10 周和第 22 周进行评估。预期的研究结果将使我们能够推进这种损伤的治疗,因为它们将有助于确定针刺干预对离心运动方案是否有额外的效果,以及任何一种针刺方式是否比其他方式更有效。

伦理和传播

本方案已获得阿拉贡伦理委员会(N° PI15/0017)的批准。试验将按照《赫尔辛基宣言》进行。

试验注册号

NCT02498795。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e46/7045155/930844d0208d/bmjopen-2019-034304f01.jpg

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