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临床试验/NCT04455659
NCT04455659已完成不适用

Impact of Adding Transcutaneous Electrical Nerve Stimulation to Conventional Physical Therapy Exercise on Pain Relief Among 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: 2019年1月20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
Pain intensity (NRS)

研究概览

简要总结

Fifty two male participants, 30-50 years old, suffering from chronic pudendal neuralgia were randomly assigned either into experimental group (26 patients) received TENS plus the traditional physical therapy program( including range of motion exercise, stretching exercise of obturator internus muscle, clam shell exercise, relaxation exercise and underwater exercise) 3 sessions per week for 8 successive weeks, or control group (26 patients) received only the traditional physical therapy exercise for the same period of time. Intensity of pain by Verbal rating scale (VRS) as well as Serum cortisol level (SCL)and Etodolac level intake are measured pre and post treatment.

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

入选标准

  • Male with ages ranged from 30 to 50 years.
  • Suffering from pudendal neuralgia and its intractable perineal pain that persists for a minimum one month beyond the acute onset.
  • Pelvic pain with sitting that relived by standing or toilet sitting.
  • Anal pain, dyspareunia and genital pain

排除标准

  • Those who had history of skin malignancy.
  • Diabetic,
  • Sensory disorders,
  • Circulatory insufficiency
  • Acute infection of the treatment area,
  • Renal failure

结局指标

主要结局

Pain intensity (NRS)

时间窗: 8 weeks of treatment

Numeric Rating Scale (NRS) for pain is a one-dimensional measure of pain intensity in adults, including those with chronic pain .It is an instrument tool to measure the intensity of pain, Numerical pain rating scale consists an 11-point numeric scale with 0 representing "no pain" and 10 representing extreme pain (Worst possible pain)

次要结局

  • Serum cortisol level(8 weeks of treatment)
  • Calculation of Etodolac Intake (ELI) in mg(8 weeks of treatment)

研究者

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

Hadaya Mosaad

Lecturer , department of physical therapy for surgery, Faculty of Physical Therapy , Cairo university.

Cairo University

研究点 (2)

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