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临床试验/NCT04243135
NCT04243135已完成不适用

Effects of Radial Extracorporeal Shock Wave Therapy (r-ESWT) on Clinical Variables and Isokinetic Performance in Patients With Knee Osteoarthritis

Mustafa Kemal University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

This study aims to compare the efficacy of r-ESWT treatment with sham-ESWT on pain, walking speed, physical function, and isokinetic muscle strength in knee osteoarthritis.

详细描述

Extracorporeal shock wave therapy (ESWT) has been increasingly used to help relieve pain and to remedy musculoskeletal disorders in recent years. ESWT seems to be an effective treatment modality many different musculoskeletal conditions, including rotator cuff tendinopathies, calcifying tendinopathy of the shoulder, lateral epicondylitis, greater trochanteric pain syndrome, patellar tendinopathy, achilles tendinopathy, plantar fasciitis, and bone disorders. ESWT seems to have chondroprotective, anti-inflammatory, neovascularization, anti-apoptotic, and tissue regeneration effect on tissues which could be relevant in the treatment of OA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Knee OA according to American College of Rheumatology (ACR) diagnostic criteria with Kellgren - Lawrence (K-L) grade 2 or 3.

排除标准

  • Patients with secondary OA,
  • severe chronic illness,
  • poor general health status (heart failure, chronic bronchitis, etc.),
  • chronic inflammatory diseases,
  • knee replacement surgery,
  • prior malignancy

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: up to 12 weeks

The VAS is used to measure and monitor pain intensity. Scores range from the absence of pain (0) to intolerable pain (0 or 10)

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

时间窗: up to 12 weeks

Pain, joint stiffness, and physical functions were evaluated by the Western Ontario and McMaster Osteoarthritis Index (WOMAC). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).

20-meter walk test

时间窗: up to 12 weeks

change from baseline on walking speed

isokinetic muscle performance

时间窗: up to 12 weeks

Isokinetic muscle performance was measured using a calibrated isokinetic test device named Humac®/NormTM Testing \& Rehabilitation System (Computer Sports Medicine Inc. Stoughton, MA, USA). The knee extensor/flexor muscle group isokinetic muscle strength \[peak torque (PT)\] of both groups was evaluated using a calibrated isokinetic dynamometer.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Turgut Yildizgoren

Principal Investigator, Clinical Assoc. Professor

Mustafa Kemal University

研究点 (1)

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