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临床试验/NCT04509518
NCT04509518已完成不适用

The Effectiveness of Selected Physical Therapy Exercise Program With or Without Transcutaneous Electrical Nerve Stimulation on Male Patients With Pudendal Neuralgia

Cairo University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年2月10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
Neumerical rating scale

研究概览

简要总结

To study the efficacy of adding Transcutaneous Electrical Nerve Stimulation (TENS) to selected physical therapy exercise program on pain in patients with pudendal neuralgia.

Fifty-two male participants with chronic pudendal neuralgia (30-50 years) shared in this study.

Methods: patients were assigned randomly into two groups equal in number; study and control groups with 26 patients in each. All patients were receiving the same physical therapy exercise program, in addition to the same prescribed analgesic medication. Patients in the study group received additional TENS therapy and those in the control group received sham TENS. Treatment was provided three sessions per week for twelve successive weeks. The participants underwent baseline and post treatment assessment for pain level as measured by three methods; Serum Cortisol Level (SCL), Daily Etodolac intake dose (DEID), and Numerical Pain Rating Scale (NPRS).

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 (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Nonsmoking male patients
  • Diagnosed as having unilateral pudendal nerve entrapment resulting in pudendal neuralgia
  • Ages ranged between 30 to 50 years
  • Did not have any behavioral or cognitive impairments that could prevent them from following simple verbal commands or instructions during tests and training.

排除标准

  • Those who had history of skin malignancy
  • Sensory disorders
  • Circulatory insufficiency
  • Acute infection of the treatment area
  • Renal failure
  • Myocardial infarction
  • Communication problems, or those with pace maker

结局指标

主要结局

Neumerical rating scale

时间窗: 12 weeks

It is composed of a numeric segmented horizontal line ranging from 0 which represents "no pain" and 10 which represents "worst imaginable pain"conditions tend to have higher values

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

Marwa Eid

assistant professor of physical therapy for surgery

Cairo University

研究点 (2)

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