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

NCT ID: NCT04455659

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-20
• Study Completion Date: 2020-05-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TENS + Conventional physical therapy exercise

Group Type: EXPERIMENTAL

Trans-cutaneous Electrical Nerve Stimulation

Intervention Type: 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

Conventional physical therapy exercise

Intervention Type: 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

conventional physical therapy exercise

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy exercise

Intervention Type: 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

Interventions

Trans-cutaneous Electrical Nerve Stimulation

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

Intervention Type: DEVICE

Conventional physical therapy exercise

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

Intervention Type: PROCEDURE

Other Intervention Names

Conventional physical therapy exercise

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hadaya Mosaad

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

1720

Identifier Type: -

Identifier Source: org_study_id