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临床试验/NCT02487914
NCT02487914已完成2 期

Iontophoresis Effects on Senses

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
1
主要终点
pain threshold- evaluated by increasing intensity of interferential current.

研究概览

简要总结

Drug delivery is conducted through various methods such as injection, phonophoresis, and iontophoresis. Iontophoresis is defined as the noninvasive delivery of active ions through epidermis using direct current. The direct current has some disadvantages such as skin burning and limited time of application. Interferential current is a kind of alternating currents without limitations of direct current; so the purpose of this study was to investigate and compare the effects of Lidocaine, interferential current and Lidocaine iontophoresis using interferential current.

详细描述

Pressure, tactile, and pain thresholds were evaluated before and after the application of Lidocaine, interferential current and Lidocaine iontophoresis using interferential current. Pressure threshold was investigated with a Pesula. Pesula is a pen-like scaled mechanical device that measures the skin pressure threshold. Pesula was pressed to the skin and pressure threshold was measured in mm. Pain and tactile thresholds were investigated using an electrical stimulator.The intensity was gradually increased to the extent that the participant reported a tingling sensation. The displayed intensity was considered as the tactile sense threshold. Then, the intensity was increased to the extent to be intolerable for the participant and this intensity was considered as the maximum pain threshold. The thresholds were recorded in milliampere.

Lidocaine iontophoresis using interferential current can increase perception threshold of pain, and pressure sense more significantly in comparison to the application of Lidocaine and interferential current alone.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • healthy women with age between 18 and 25 years old

排除标准

  • Systemic disorders,
  • neuro-muscular diseases such as diabetes and all forms of neuropathies,
  • and use of narcoleptic drugs which may contaminate the results.
  • Also, none of the participants were on their menstrual cycle.

研究组 & 干预措施

lidocaine iontophoresis using interferential current

Active Comparator

the threshold of pressure, tactile,and pain thresholds were evaluated after the iontophoresis of Lidocaine using interferential current.

干预措施: iontophoresis of Lidocaine 10% with interferential current (Dynatron 438) (Device)

interferential current

Active Comparator

the threshold of pressure, tactile,and pain thresholds were evaluated after the application of interferential current.

干预措施: interferential current (Device)

lidocaine

Active Comparator

the threshold of pressure, tactile,and pain thresholds were evaluated after the application of topical Lidocaine.

干预措施: Lidocaine 10% was sprayed at the identified region (Drug)

结局指标

主要结局

pain threshold- evaluated by increasing intensity of interferential current.

时间窗: up to one week

pain threshold to increasing intensity of interferential current.

次要结局

  • tactile threshold- evaluated by exact perception of the lowest level of interferential current(up to one week)
  • pressure threshold- evaluated by Pesula(up to one week)

研究者

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

Alireza Motealleh

Dr. Amin Kordi Yoosefinejad

Shiraz University of Medical Sciences

研究点 (1)

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