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

Not Applicable

Completed

• Conditions: Pudendal Neuralgia
• Interventions: Procedure: Conventional physical therapy exercise; Device: Trans-cutaneous Electrical Nerve Stimulation

• Registration Number: NCT04455659
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-20
• Primary Completion: 2020-05-25
• Study Completion: 2020-05-25
• Status Verified: 2020-06
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-29
• Last Update Submitted: 2020-06-29
• Study First Posted: 2020-07-02
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional physical therapy exercise	Conventional physical therapy exercise	-
TENS + Conventional physical therapy exercise	Conventional physical therapy exercise	-
TENS + Conventional physical therapy exercise	Trans-cutaneous Electrical Nerve Stimulation	-

Primary Outcome Measures

Name	Time	Method
Pain intensity (NRS)	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 Outcome Measures

Name	Time	Method
Serum cortisol level	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
Calculation of Etodolac Intake (ELI) in mg	8 weeks of treatment	It was done before and after the treatment program

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Giza, Egypt