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

Pudendal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04509518
• Other study ID #: PN
• Status: Completed
• Phase: N/A
• Start date: February 10, 2018
• Est. completion date: December 7, 2019

Study information

• Verified date: August 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 7, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Pudendal Neuralgia

Intervention

Other:
• Exercise therapy program plus TENS therapy
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

Locations

Country	Name	City	State
Egypt	Marwa Eid	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks