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Clinical Trials/NCT04509518
NCT04509518
Completed
Not Applicable

The Effectiveness of Selected Physical Therapy Exercise Program With or Without Transcutaneous Electrical Nerve Stimulation on Male Patients With Pudendal Neuralgia

Cairo University1 site in 1 country52 target enrollmentFebruary 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pudendal Neuralgia
Sponsor
Cairo University
Enrollment
52
Locations
1
Primary Endpoint
Neumerical rating scale
Status
Completed
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
February 10, 2018
End Date
December 7, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marwa Eid

assistant professor of physical therapy for surgery

Cairo University

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
  • Sensory disorders
  • Circulatory insufficiency
  • Acute infection of the treatment area
  • Renal failure
  • Myocardial infarction
  • Communication problems, or those with pace maker

Outcomes

Primary Outcomes

Neumerical rating scale

Time Frame: 12 weeks

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

Study Sites (1)

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