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

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).

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Key information

Conditions

Pudendal Neuralgia Nerve Compression Syndromes Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

30 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Marwa Eid

Cairo, 2011, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise therapy program plus TENS therapy

Other

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 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Aug 12, 2020
Registry last updated: Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed