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

Impact of Adding Transcutaneous Electrical Nerve Stimulation 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.

Study Overview

• Status: Completed
• Conditions: Pudendal Neuralgia
• Intervention / Treatment: Device: Trans-cutaneous Electrical Nerve Stimulation; Procedure: Conventional physical therapy exercise

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 12322
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENS + Conventional physical therapy exercise	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; Other Names: Conventional physical therapy exercise; 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
Active Comparator: conventional physical therapy exercise	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Calculation of Etodolac Intake (ELI) in mg	It was done before and after the treatment program	8 weeks of treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2019
• Primary Completion (Actual): May 25, 2020
• Study Completion (Actual): May 25, 2020

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Neuralgia; Pudendal Neuralgia
• Other Study ID Numbers: 1720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: we will share study protocol after 6 months from publication.
• IPD Sharing Time Frame: After 6 months from publication.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No