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

Pudendal Neuralgia Clinical Trial

— TENS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455659
• Other study ID #: 1720
• Status: Completed
• Phase: N/A
• Start date: January 20, 2019
• Est. completion date: May 25, 2020

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 25, 2020
• Est. primary completion date: May 25, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Pudendal Neuralgia

Intervention

Device:
• 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

Procedure:
• 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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum cortisol level	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	8 weeks of treatment
Secondary	Calculation of Etodolac Intake (ELI) in mg	It was done before and after the treatment program	8 weeks of treatment