Skip to main content
OpenTrials
Completed

NCT Number: NCT04455659

Impact of Adding TENS to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Giza Governorate, 12322, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trans-cutaneous Electrical Nerve Stimulation

Device

TENS that was applied once daily, three times per week for 8 weeks. Each treatment session was conducted for 20 minutes, two electrodes were positioned over the perineal area between anus and scrotum on the Centrum tendineum, while the other two electrodes were applied under the buttocks medially at the level of the ischial spines (medial to the ischial spines bilaterally) with the patient in comfortable supine hook-lying position with abducted hips. to prevent burn beneath the electrodes, the surface area of the electrode should be equal to or greater than 4 cm2 to minimize the heat production. In addition, to decrease the current density between electrodes, the inter-electrode distance was less than the cross sectional area of the electrode

Other names: Conventional physical therapy exercise

Conventional physical therapy exercise

Procedure

physical therapy program for 30 minutes, and 3 times per week for 8 weeks in the form of strengthening exercise, clam - shell exercise, and stretching exercise focusing on obturator internus muscle, range of motion exercise for the hip and pelvis musculature for 30 minute three times a week for consecutive 8 weeks , each type of exercise was performed for a duration of 6 seconds and repeated 10 times

Primary outcomes

  1. 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

  1. Serum cortisol level

    Time frame: 8 weeks of treatment

    A venous blood sample of 8 CC was taken at the morning, centrifuged and stored at 20ºC till analyzed, Normal cortisol level ranged from 9-25 µg/dL at morning and patients with painful conditions tended to have higher than normal SCL

  2. Calculation of Etodolac Intake (ELI) in mg

    Time frame: 8 weeks of treatment

    It was done before and after the treatment program

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: TENS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2020
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.