Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment
研究概览
简要总结
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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?
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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
- 否
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
研究组 & 干预措施
Group A (Control group)
Group A (n=27) will receive a conventional physical therapy program only for 5 weeks in the form of Splinting, Ultrasound and Exercises.
干预措施: Neural mobilization exercises of the ulnar nerve (Other)
Group B (Chitosan phonophoresis group)
Patients in group B (n=27) will receive phonophoresis with chitosan nanoparticles. Patients will also receive the conventional physical therapy program: in the form of Splinting, Ultrasound and Exercises. Session will be applied 3 times per week for a total of 5 weeks.
干预措施: Therapeutic Ultrasound (Device)
Group B (Chitosan phonophoresis group)
Patients in group B (n=27) will receive phonophoresis with chitosan nanoparticles. Patients will also receive the conventional physical therapy program: in the form of Splinting, Ultrasound and Exercises. Session will be applied 3 times per week for a total of 5 weeks.
干预措施: Splinting (Device)
Group B (Chitosan phonophoresis group)
Patients in group B (n=27) will receive phonophoresis with chitosan nanoparticles. Patients will also receive the conventional physical therapy program: in the form of Splinting, Ultrasound and Exercises. Session will be applied 3 times per week for a total of 5 weeks.
干预措施: Neural mobilization exercises of the ulnar nerve (Other)
Group A (Control group)
Group A (n=27) will receive a conventional physical therapy program only for 5 weeks in the form of Splinting, Ultrasound and Exercises.
干预措施: Chitosan Phonophoresis (Device)
Group A (Control group)
Group A (n=27) will receive a conventional physical therapy program only for 5 weeks in the form of Splinting, Ultrasound and Exercises.
干预措施: Splinting (Device)
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
Mohamed Magdy Ali Hassan ElMeligie
Principal investigator
October 6 University