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

NCT04455659 | Completed DMC

• 1 other identifier: 1720
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Pudendal Neuralgia

Outcome Measures

Primary Outcomes (1)

• Pain intensity (NRS)

  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)

  8 weeks of treatment

Secondary Outcomes (2)

• Serum cortisol level

  8 weeks of treatment

• Calculation of Etodolac Intake (ELI) in mg

  8 weeks of treatment

Study Arms (2)

TENS + Conventional physical therapy exercise

EXPERIMENTAL

Device: Trans-cutaneous Electrical Nerve Stimulation; Procedure: Conventional physical therapy exercise

conventional physical therapy exercise

ACTIVE COMPARATOR

Procedure: Conventional physical therapy exercise

Interventions

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

Also known as: Conventional physical therapy exercise

TENS + 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

TENS + Conventional physical therapy exercise; conventional physical therapy exercise

Eligibility Criteria

• Age: 30 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 12322, Egypt

Location

MeSH Terms

Conditions

Pudendal Neuralgia

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer , department of physical therapy for surgery, Faculty of Physical Therapy , Cairo university.

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: January 20, 2019
• Primary Completion: May 25, 2020
• Study Completion: May 25, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After 6 months from publication.

Locations

EG (1)