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临床试验/NCT06478914
NCT06478914已完成不适用

Effect of Neuromuscular Electrical Stimulation Versus Low-intensity Laser in Relation to Motor Conduction Velocity of the Neuropathic Common Peroneal Nerve Post Burn

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2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
60
试验地点
1
主要终点
motor conduction velocity (MCV)

研究概览

简要总结

Purposes of this study were the following:

  1. To evaluate the therapeutic efficacy of NMES in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.
  2. To evaluate the therapeutic efficacy of LIL in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.
  3. To detect which one of both was the better and most effective than the other in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.

详细描述

Burned patients experience various problems, including skin damage, vascular damage, and metabolic stress. These injuries can lead to peripheral neuropathies, which can affect nerve function and cause weakness or lack of sensation. Lymphatic damage can delay wound healing, causing contractures that affect the patient's physical function. Burn-Associated polyneuropathy (BAPN) is common after thermal injury, affecting nerve function. Electrophysiological assessments of muscle and nerves are essential in neurology, physical therapy, and related clinical disciplines. Neuromuscular electrical stimulation (NMES) is used to increase force output, strengthen muscles, and control pain. Low-intensity laser therapy (LILT) is used to treat chronic inflammatory and fibrotic conditions, improving absorption of fluid, secretion of macrophage growth factors, DNA synthesis, pain reduction, and electron respiratory chain reaction. However, the effect of LILT on scar formation and treatment of fibrosis or calcification secondary to hematomas or fat necrosis is not yet evaluated.

The need for this study developed from the lack of quantitative knowledge and information in the published studies about the application of both NMES and LIL to improve the neuropathic common peroneal nerve postburn.

The significance of this study arises from the rarity of information about the effectiveness of both NMES and LIL on the neuropathic common peroneal nerve post-burn, as well as the precise dosage and frequency of treatment required to promote improvement of the neuropathic common peroneal nerve post burn.

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)

盲法说明

single-blind blinded randomized controlled trial

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients were chosen after a routine medical examination by specialist.
  • All patients were approximately of the same age (from 20 to 35 years old).
  • All patients were conscious.
  • All of them were non-smokers and they will be under own prescribed medications described by their physicians.
  • They received another physical therapy electromodality except NMES and LIL as well as the traditional physical therapy in the form of 5 minutes of deep stroking (Effleurage) maneuver for the affected lower limb before the beginning of the MCV recording to eliminate the temperature-related variability

排除标准

  • Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases will be excluded from the study.
  • Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases will be excluded from the study.
  • Pregnant patients or who presented with active malignancy will be excluded from the study.
  • Patients who suffer from hyperthyroidism, haemorrhage, acute viral diseases, acute tuberculosis, mental disorders or those with pace makers will be excluded from the study

结局指标

主要结局

motor conduction velocity (MCV)

时间窗: at base line and following 8 weeks

The study involved a common peroneal nerve MCV measurement in an air-conditioned room. The subject was placed in a supine position for 5 minutes to rest and relax. The recording electrodes were placed over the EDB muscle, with the active electrode placed over the main bulk of the muscle. The stimulating electrodes were placed 8 cm proximal to the active electrode for distal latency and distally in the lateral part of the popliteal fossa for proximal latency. The subject was then asked to lie supine for 5 minutes for leg massage, rest, and relaxation. The EMG12 program disk was loaded, and electrodes were connected to the active channels and common electrode. The program was moved to the ready condition after pressing keys on the keyboard. The sensitivity was 1 mv/diameter, the sweep speed was 3 ms, and the stimulus intensity ranged from 0.1 to 99 mA. Segmental distances between stimulation points were measured using a tape measure.

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

Basma Rabie Ahmed Fadel

Basma Rabie Ahmed

Cairo University

研究点 (1)

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