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

Not Applicable

Completed

• Conditions: Pudendal Neuralgia
• Interventions: Other: Exercise therapy program plus TENS therapy

• Registration Number: NCT04509518
• Lead Sponsor: Cairo University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-10
• Primary Completion: 2019-04-05
• Study Completion: 2019-12-07
• Status Verified: 2020-08
• Study First Submitted: 2020-08-09
• Study First Submitted QC: 2020-08-09
• Last Update Submitted: 2020-08-09
• Study First Posted: 2020-08-12
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Exercise therapy program plus TENS therapy	Participants in the study group received exercise therapy program plus additional TENS therapy
Control group	Exercise therapy program plus TENS therapy	Participants in the study group received exercise therapy program plus sham TENS

Primary Outcome Measures

Name	Time	Method
Neumerical rating scale	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

Trial Locations

Locations (1)

Marwa Eid; 🇪🇬 Cairo, Egypt