Chronic Pelvic Pain Syndrome in Males

Not Applicable

Completed

• Conditions: Pelvic Pain Syndrome
• Interventions: Other: EXERCISE; Other: TENS; Other: ESWT

• Registration Number: NCT06369545
• Lead Sponsor: Biruni University

Brief Summary

The aim of this study is to evaluate the effectiveness of ESWT (Extracorporeal Shock Wave Therapy) and TENS (Transcutaneous Electrical Nerve Stimulation) in individuals diagnosed with chronic pelvic pain syndrome and treated with medication. The study was organized as a randomized controlled trial. The sample size is 30 patients suffering from chronic pelvic pain syndrome.

Detailed Description

Volunteers who are between the ages of 20-40, diagnosed with chronic pelvic pain syndrome, and who meet the inclusion criteria will be included in the study and will be randomized into 2 groups: Group I (TENS) and Group II (ESWT).

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-03-29
• Primary Completion: 2024-04-04
• Study First Submitted QC: 2024-04-13
• Study First Posted: 2024-04-17
• Study Completion: 2024-08-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

Inclusion Criteria

1. Aged between 20-40 years old males
2. Diagnosis of Chronic Pelvic Pain Syndrome

Exclusion Criteria

1. Cancer

2. Surgery related to pelvic floor

3. Receiving drug treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP I: TENS	EXERCISE	PHYSIOTHERAPY PROGRAM PLUS TENS
GROUP I: TENS	TENS	PHYSIOTHERAPY PROGRAM PLUS TENS
GROUP II: ESWT	ESWT	PHYSIOTHERAPY PROGRAM PLUS ESWT
GROUP II: ESWT	EXERCISE	PHYSIOTHERAPY PROGRAM PLUS ESWT

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)	baseline and immediately after the intervention	This assesses the quality of life. The index has sub dimensions(pain, urinary symptoms, quality of life impact).; The score evaluation of the pain scale is between 1 and 21 points, the score evaluation of the urination scale is between 0 and 10 points, and the score evaluation of the quality of life scale is between 0 and 12 points.
VISUAL ANALOUGE SCALE	baseline and immediately after the intervention	It evaluates pain intensity grading between 0-10. Higher score shows severe pain.
ALGOMETER	baseline and immediately after the intervention	This evaluates pain tolerance threshold of the patients.The less score shows pain intolerance.

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale- HAD	baseline and immediately after the intervention	This evaluates depresive symtoms of the patients.This scale is a self-rating scale. The scale is a 4-point Likert type scale consisting of 14 items in total, including anxiety and depression subscales (Aydemir, Güvenir, Küey, \& Kültür, 1997). 7 items in the scale are for anxiety and 7 items are for depression. Participants will be asked to mark each item considering the situation they have experienced in the last week. Each item contains four options. Options will be scored between 0-3 points. The lowest score for the anxiety and depression subscales is 0 and the highest score is 21 points.
Lasegue Test	baseline and immediately after the intervention	To measure flexibility of the sciatic nerve, manually.
Nottingham Health Profile-NHP	baseline and immediately after the intervention	This evaluates quality of life of the patients. The survey consists of 6 sections. These sections are pain, emotional reactions, social isolation, physical activity, energy and sleep. It consists of 38 items in total. Each section is scored between 0-100 points. 0 will be considered the best score and 100 will be considered the worst score.
Digital Muscle Testing	baseline and immediately after the intervention	To evaluate muscles's strenght using by Power Track. Higher cosre shows good strneght.
Flexibility Measurements	baseline and immediately after the intervention	To measure flexibility of the muscles, manually. The amount of elasticity is measured and the result is recorded in cm.
ROM Assessments	baseline and immediately after the intervention	To measure range of motion of the joints by using goniometer.

Trial Locations

Locations (1)

Faculty of Health Sciences in Biruni University; 🇹🇷 İ̇stanbul, Zeytinburnu, Turkey