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临床试验/NCT05212311
NCT05212311已完成不适用

Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome: A Randomized Controlled Trial

October 6 University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2022年3月8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
54
试验地点
2
主要终点
Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment

研究概览

简要总结

  • This study will be conducted to answer the following question: Is there a statistically significant effect of chitosan phonophoresis on ulnar nerve conduction velocity, pain level & function in patients with mild to moderate cubital tunnel syndrome?

  • Fifty-four subjects suffering from mild to moderate cubital tunnel syndrome according to modified McGowan grading system (Palmer & Hughes, 2010) from both sexes diagnosed clinically by electromyography will be recruited for this study. The Age of the participants will range from 20 - 40 years old. Participants with Body mass index between 18.5 and 24.9kg/m2.

EMS physio Ltd ultrasound device will be used in combination with chitosan nanoparticles gel.

Electrodiagnostic test will be performed for ulnar nerve conduction velocity using Neuropack S1 MEB-9004 NIHON KODEN, JAPAN. Visual analogue scale (VAS) will be used to determine pain level. Quick DASH will be used to determine hand function.Patients will have 3 sessions per week for 5 weeks.

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 (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Fifty-four patients suffering from mild to moderate Cubital tunnel syndrome from both sexes according to modified McGowan grading system (Palmer & Hughes, 2010) & have motor conduction velocity across the elbow less than 50 m/s or the difference between the motor conduction velocity across the elbow and that below the elbow exceeds 10 m/s (Padua et al., 2001).
  • Age ranging from 20-
  • All participants will have Body mass index between 18.5 and 24.9 kg/m2.

排除标准

  • 1- Diabetic patients. 2- Cardiovascular patients 3- Patients with cervical spondylosis 4- Patients with cervical disc prolapsed 5- Patients with Thoracic outlet syndrome 6- Patients with carpal tunnel syndrome. 7- Pregnant women 8- Patients with fibromyalgia 9- Patients with epicondylitis 10- Patient with previous elbow injuries 11- Patient with Breast Cancer. 12- Patient with Guyon Canal syndrome 13- Smokers

结局指标

主要结局

Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment

时间窗: Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment

Measurement of how quickly an electrical impulse moves along the nerve.

次要结局

  • Changes in function using QUICK DASH scale at 5 weeks posttreatment(Changes in function using QUICK DASH scale from baseline and 5 weeks posttreatment)
  • Changes in pain intensity at 5 weeks posttreatment(Changes in pain intensity from baseline and 5 weeks posttreatment)

研究者

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

Mohamed Magdy Ali Hassan ElMeligie

Principal investigator

October 6 University

研究点 (2)

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