Skip to main content
Clinical Trials/NCT04455659
NCT04455659
Completed
Not Applicable

Impact of Adding Transcutaneous Electrical Nerve Stimulation to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia.

Cairo University1 site in 1 country52 target enrollmentJanuary 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pudendal Neuralgia
Sponsor
Cairo University
Enrollment
52
Locations
1
Primary Endpoint
Pain intensity (NRS)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 20, 2019
End Date
May 25, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hadaya Mosaad

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

Cairo University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Pain intensity (NRS)

Time Frame: 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)

Secondary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials