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

Study Overview
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Brief Summary
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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).

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

Conditions
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Pudendal Neuralgia

Intervention / Treatment
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* Other: Exercise therapy program plus TENS therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Participants in the study group received exercise therapy program plus additional TENS therapy | Other: Exercise therapy program plus TENS therapy<br>* 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<br>|
| Other: Control group<br>Participants in the study group received exercise therapy program plus sham TENS | Other: Exercise therapy program plus TENS therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 painconditions tend to have higher values | 12 weeks |