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

Primary Purpose

Pudendal Neuralgia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Trans-cutaneous Electrical Nerve Stimulation
Conventional physical therapy exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pudendal Neuralgia

Eligibility Criteria

30 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TENS + Conventional physical therapy exercise

conventional physical therapy exercise

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
Calculation of Etodolac Intake (ELI) in mg
It was done before and after the treatment program

Full Information

First Posted
June 29, 2020
Last Updated
June 29, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04455659
Brief Title
Impact of Adding TENS to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia.
Acronym
TENS
Official Title
Impact of Adding Transcutaneous Electrical Nerve Stimulation to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
May 25, 2020 (Actual)
Study Completion Date
May 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pudendal Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS + Conventional physical therapy exercise
Arm Type
Experimental
Arm Title
conventional physical therapy exercise
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Trans-cutaneous Electrical Nerve Stimulation
Other Intervention Name(s)
Conventional physical therapy exercise
Intervention Description
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
Procedure
Intervention Name(s)
Conventional physical therapy exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain intensity (NRS)
Description
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)
Time Frame
8 weeks of treatment
Secondary Outcome Measure Information:
Title
Serum cortisol level
Description
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
Time Frame
8 weeks of treatment
Title
Calculation of Etodolac Intake (ELI) in mg
Description
It was done before and after the treatment program
Time Frame
8 weeks of treatment

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Giza
ZIP/Postal Code
12322
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
we will share study protocol after 6 months from publication.
IPD Sharing Time Frame
After 6 months from publication.

Learn more about this trial

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

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