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临床试验/NCT05637684
NCT05637684已完成不适用

Influence of Low Intensity Pulsed Ultrasound on Enhancing Biostimulation of Median Nerve in Patients With Chronic Carpal Tunnel Syndrome

Cairo University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年11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
52
试验地点
2
主要终点
median nerve sensory distal latency

研究概览

简要总结

To investigate the influence of low intensity pulsed ultrasound on Pain level, pinch grip strength, sensory distal latency of the median nerve, motor distal latency of the median nerve and hand function in patients with chronic carpal tunnel syndrome

详细描述

Carpal tunnel syndrome (CTS) is an entrapment neuropathy caused by compression of the median nerve as it travels through the wrist's carpal tunnel. It is the most common nerve entrapment neuropathy, accounting for 90% of all neuropathies. Early symptoms of carpal tunnel syndrome include pain, numbness, and paresthesia. These symptoms typically present, with some variability, in the thumb, index finger, middle finger, and the radial half (thumb side) of the ring finger. Pain also can radiate up the affected arm. With further progression, hand weakness, decreased fine motor coordination, clumsiness, and thenar atrophy can occur.

Low-intensity ultrasound (LIU) and low-intensity pulsed ultrasound (LIPUS) are known to have positive effects on dentin genesis, cell proliferation, protein synthesis, collagen synthesis, membrane permeability, and integrin expression and to increase cytosolic calcium levels.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • 26 male and 26 female patients have unilateral with mild to moderate CTS in dominant hand diagnosed and referred by physician.
  • Age will be ranged from 30-50 years
  • All patients have body mass index between 18.5 and 24.9 kg/m2
  • Median nerve sensory distal latency > 3.5 millisecond but not more than 4.5 millisecond, motor distal latency longer than 4.2 millisecond but not exceed 6.5 millisecond.
  • Positive clinical manifestation (pain, paresthesia in the distribution of the median nerve for 6 months, positive Tinel's and Phalen's sign)

排除标准

  • Patients with diabetes mellitus ( type I or type II),
  • Patients with hypothyroidism
  • Patients with rheumatoid disease
  • Patients with renal disease
  • Patients with polyneuropathy
  • patients with cervical radiculopathy
  • Patients with wrist arthritis , wrist fracture and acute trauma
  • Patients with Carpal tunnel release surgery
  • Patients with outlet syndrome
  • thenar muscle atrophy -

结局指标

主要结局

median nerve sensory distal latency

时间窗: 4 WEEKS

Measurements of sensory distal latency of median nerve (Antidromic technique ) 1. Recording electrode or Ring electrode (R1, R2): at the index finger the negative electrode is between 2-3 cm to positive electrode (Distance between stimulating and recording sites 5 cm). 2. Stimulating site (S): at the wrist (Middle of the wrist between the tendons to the flexor carpi radialis and palmaris longus) Ground (Earth) electrode (G): between stimulating and recording electrodes will be placed at the palmar surface of the wrist crease.

median nerve motor distal latency

时间窗: 4 WEEKS

Measurements of motor distal latency of median nerve (Using Orthodromic technique) 1. Recording (-) active electrode (R1): abductor pollicis brevis (APB). Reference(+) electrode (R2): placed over the first metacarpal-phalangeal joint 2. Stimulating electrode (S): 2 stimulating sites at wrist and antecubital fossa (Cathode toward recording electrode). 3. Ground (Earth) electrode (G): around the wrist crease between stimulating and recording electrodes

pinch grip strength

时间窗: 4 weeks

grip strength will be measured using a calibrated baseline hydraulic dynamometer, while the subject will be seated with the arm adducted, elbow flexed at 90 degree, forearm in neutral position firstly, therapist will ask patient to hold the dynamometer between the tip of the thumb and tip of the index finger it called (tip to tip pinch), as hard as possible in the hand to be tested, the patients strongly encouraged to give a maximum effort. One practice trial, Repeat the test 3 times and calculate an average with one min rest in between

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

fahd abdelazim hassan abdelgalil

principle investigator

Cairo University

研究点 (2)

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