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Effectiveness of Selected Physical Therapy Exercise Program and Transcutaneous Electrical Nerve Stimulation on Patients With Pudendal Neuralgia

Primary Purpose

Pudendal Neuralgia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Exercise therapy program plus TENS therapy
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:

  • Nonsmoking male patients
  • Diagnosed as having unilateral pudendal nerve entrapment resulting in pudendal neuralgia
  • Ages ranged between 30 to 50 years
  • Did not have any behavioral or cognitive impairments that could prevent them from following simple verbal commands or instructions during tests and training.

Exclusion Criteria:

  • Those who had history of skin malignancy
  • Diabetes
  • Sensory disorders
  • Circulatory insufficiency
  • Acute infection of the treatment area
  • Renal failure
  • Myocardial infarction
  • Communication problems, or those with pace maker

Sites / Locations

  • Marwa Eid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Study group

Control group

Arm Description

Participants in the study group received exercise therapy program plus additional TENS therapy

Participants in the study group received exercise therapy program plus sham TENS

Outcomes

Primary Outcome Measures

Neumerical rating scale
It is composed of a numeric segmented horizontal line ranging from 0 which represents "no pain" and 10 which represents "worst imaginable pain"conditions tend to have higher values

Secondary Outcome Measures

Full Information

First Posted
August 9, 2020
Last Updated
August 9, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04509518
Brief Title
Effectiveness of Selected Physical Therapy Exercise Program and Transcutaneous Electrical Nerve Stimulation on Patients With Pudendal Neuralgia
Official Title
The Effectiveness of Selected Physical Therapy Exercise Program With or Without Transcutaneous Electrical Nerve Stimulation on Male Patients With Pudendal Neuralgia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
December 7, 2019 (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

5. Study Description

Brief Summary
To study the efficacy of adding Transcutaneous Electrical Nerve Stimulation (TENS) to selected physical therapy exercise program on pain in patients with pudendal neuralgia. Fifty-two male participants with chronic pudendal neuralgia (30-50 years) shared in this study. Methods: patients were assigned randomly into two groups equal in number; study and control groups with 26 patients in each. All patients were receiving the same physical therapy exercise program, in addition to the same prescribed analgesic medication. Patients in the study group received additional TENS therapy and those in the control group received sham TENS. Treatment was provided three sessions per week for twelve successive weeks. The participants underwent baseline and post treatment assessment for pain level as measured by three methods; Serum Cortisol Level (SCL), Daily Etodolac intake dose (DEID), and Numerical Pain Rating Scale (NPRS).

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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Participants in the study group received exercise therapy program plus additional TENS therapy
Arm Title
Control group
Arm Type
Other
Arm Description
Participants in the study group received exercise therapy program plus sham TENS
Intervention Type
Other
Intervention Name(s)
Exercise therapy program plus TENS therapy
Intervention Description
All patients were receiving the same physical therapy exercise program, 3 times per week for 12 weeks in the form of pelvic floor relaxation exercises, diastasis correction exercises , myofascial trigger points release, connective tissue manipulation and progressive abdominal strengthening exercises. Pelvic floor relaxation exercises included pelvic floor release stretches, Proprioceptive Neuromuscular Facilitation technique, and pelvic floor drop exercises in addition to TENS therapy The standard protocol for TENS therapy in this group was 20 minutes of 100 Hz frequency, pulse duration of 200 µsec, three times a week for successive 12 weeks
Primary Outcome Measure Information:
Title
Neumerical rating scale
Description
It is composed of a numeric segmented horizontal line ranging from 0 which represents "no pain" and 10 which represents "worst imaginable pain"conditions tend to have higher values
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Nonsmoking male patients Diagnosed as having unilateral pudendal nerve entrapment resulting in pudendal neuralgia Ages ranged between 30 to 50 years Did not have any behavioral or cognitive impairments that could prevent them from following simple verbal commands or instructions during tests and training. Exclusion Criteria: Those who had history of skin malignancy Diabetes Sensory disorders Circulatory insufficiency Acute infection of the treatment area Renal failure Myocardial infarction Communication problems, or those with pace maker
Facility Information:
Facility Name
Marwa Eid
City
Cairo
ZIP/Postal Code
2011
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Effectiveness of Selected Physical Therapy Exercise Program and Transcutaneous Electrical Nerve Stimulation on Patients With Pudendal Neuralgia

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