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临床试验/NCT04731350
NCT04731350已完成不适用

Effect of Extra Corporeal Shock Wave Versus Dexamethasone Iontophoresis in Treatment of Knee Osteoarthritis

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
visual analogue scale (VAS)

研究概览

简要总结

Both extra corporeal shock wave and dexamethasone iontophoresisare effective in treatment of knee osteoarthritis but which one is more effective is not clear yet . so the purpose of this study was to investigate and compare between the effect of shock wave and iontophoresis in treatment of knee osteoarthritis . it was hypothesized that there will be no difference between the effect of shock wave and iontophoresis on treatment of knee osteoarthritis.

详细描述

60 subjects with grade II knee osteoarthritis will be recruited from outpatient clinic of faculty of physical therapy and then they will be assigned randomly by sealed envelope into three groups ;group A (shock wave group) will received radial extracorporeal shock wave ,group B (Iontophoresis group ) will receive deaxamthasone iontophoresis and group c (control group) will receive traditional tratment ( stregnthening exerciseces) all treatment will be once session per week for four weeks .pain intensity ,knee ROM and knee injury and osteoarthritis outcome score physical function short (KOOS-PS).

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
Single (Participant)

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Symptomatic knee OA for at least 3 months according to clinical criteria of American College of Rheumatology
  • •Radiologic findings had to be compatible with knee OA, with kelgren and Lawrence (K-L) grade 2 in a simple X ray .
  • •Tenderness on medial tibial plateau
  • •Intensity of pain: visual analogue scale equal to 5 or greater
  • •Failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others)

排除标准

  • •Neuorological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months
  • •Any contraindication to magnetic resonance imaging or radiography, or trauma history on knee
  • •history of previous knee surgery -

研究组 & 干预措施

Shock wave(A)

Experimental

subjects will recive radial extracorporeal shock wave (2000 shock/session, 10Hz and EFD 0.178 mJ/mm²) on knee joints once per week for four weeks in addition to strengthening exercise

干预措施: radial extracorporeal shock wave (Device)

Shock wave(A)

Experimental

subjects will recive radial extracorporeal shock wave (2000 shock/session, 10Hz and EFD 0.178 mJ/mm²) on knee joints once per week for four weeks in addition to strengthening exercise

干预措施: Exercise (Other)

Iontophoresis (B)

Experimental

subjects will recive dexamethasone iontophoresis on knee joints once per week for four weeks in addition to strengthening exercise

干预措施: iontophoresis (Device)

Iontophoresis (B)

Experimental

subjects will recive dexamethasone iontophoresis on knee joints once per week for four weeks in addition to strengthening exercise

干预措施: Exercise (Other)

Control (C)

Other

stregnthening exercise;straight leg raising exercisein which the patients were positioned in the crook lying position with the unexercised limb was the flexed one then the patients were asked to contract the quadriceps muscle and elevate the limb to 45º and hold for 6 seconds, slowly lower the limb and then relax for 6 seconds, three sets of 10 repetitions were don ,Isometric quadriceps contraction (quadriceps drill) in full knee extension maintained for 5 seconds, followed by a 5-second rest; the exercise was performed for 20 repetitions per session .treatment once per week for four weeks

干预措施: Exercise (Other)

结局指标

主要结局

visual analogue scale (VAS)

时间窗: change from baseline to immediately pre treatment and from pre treatment to immediately post treatment

pain intensity will be assessed by using visual analogue scale

次要结局

  • knee injury and osteoarthritis outcome score physical function short (KOOS-PS)(change from baseline to immediately pre treatment and from pre treatment to immediately post treatment)
  • knee range of motion (ROM)(change from baseline to immediately pre treatment and from pre treatment to immediately post treatment)

研究者

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

Shimaa Taha Abu El Kasem

principle investigator

Cairo University

研究点 (1)

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