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临床试验/NCT06532045
NCT06532045终止不适用

Effect of Transcutaneous Electrical Nerve Stimulation on Patients With Palmar Hyperhidrosis

Cairo University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
56
试验地点
2
主要终点
Change the severity of hyperhidrosis

研究概览

简要总结

To investigate the effectiveness of Transcutaneous Electrical Nerve Stimulation on Hyperhidrosis Severity on patients with primary Palmar Hyperhidrosis.

详细描述

Hyperhidrosis might be a primary condition or secondary condition due to medications or systemic disorders. Primary hyperhidrosis is usually focal,bilateral, and symmetric. It mainly affects the axillae, palms, soles, face, and scalp. The incidence of primary hyperhidrosis has been reported to be between 0.6%~2.8% in both genders. Symptoms usually begin in childhood or around puberty. It interferes with daily social and occupational activities of patients and significantly impacts their quality of life.

Various treatments have been proposed to control primary hyperhidrosis. The treatment options for hyperhidrosis include topical therapy, anticholinergic, iontophoresis, botulinum toxin and surgery.

In addition to these treatment options for hyperhidrosis, several medical devices delivering energy to destroy sweat glands are undergoing promising clinical investigation. Microwave technology, several lasers (such as 1,064-nm, 1,320-nm, and 1,440-nm neodymium: yttrium- aluminum-garnet laser, 924-nm and 975-nm diode laser, long-pulsed 800- nm diode laser), micro needle radio frequency, and ultrasound technology could be included as example of the device.

In spite of these treatment options, the best therapeutic choice is still undefined. This concept encourages us to investigate the effectiveness of recent technique in the current research.

Up till now, the available literatures show a gap in knowledge and lack of well-designed studies. We will concern on the effect of Transcutaneous Electrical Nerve Stimulation on Hyperhidrosis Severity on patients with primary Palmar Hyperhidrosis.

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
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Age range from 18 to 30 years old.
  • Patients will be from both sexes.
  • Body mass index from 18.5 to 24.9
  • Subject suffer from primary palmar hyperhidrosis.
  • No clinical treatment for palmar hyperhidrosis within the past month.

排除标准

  • • Patients outside the target range.
  • Patients who were pregnant or lactating.
  • Patients who had metal implants such as a pacemaker.
  • Patients who had history of ischemic heart disease or arrhythmias.
  • Patients who had any other diseases that could be the cause ofsecondary hyperhidrosis.

结局指标

主要结局

Change the severity of hyperhidrosis

时间窗: 2 weeks

Measure the rate sweating by iodine starch testin unit of score

次要结局

  • Change the quality of life(2 weeks)

研究者

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

Mahmoud Mohamed

Professor doctor

Cairo University

研究点 (2)

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