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Clinical Trials/NCT06369545
NCT06369545
Completed
Not Applicable

Examination of the Efficacy of ESWT (Extracorporeal Shock Wave Therapy) and TENS (Transcutaneous Electrical Nerve Stimulation) in Individuals Receiving Drug Treatment for Chronic Pelvic Pain Syndrome: Randomized Controlled Study

Biruni University1 site in 1 country38 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Pain Syndrome
Sponsor
Biruni University
Enrollment
38
Locations
1
Primary Endpoint
National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
August 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Biruni University
Responsible Party
Principal Investigator
Principal Investigator

Ugur Cavlak

Clinical Professor

Biruni University

Eligibility Criteria

Inclusion Criteria

  • Aged between 20-40 years old males
  • Diagnosis of Chronic Pelvic Pain Syndrome

Exclusion Criteria

  • Surgery related to pelvic floor
  • Receiving drug treatment

Outcomes

Primary Outcomes

National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)

Time Frame: 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

Time Frame: baseline and immediately after the intervention

It evaluates pain intensity grading between 0-10. Higher score shows severe pain.

ALGOMETER

Time Frame: baseline and immediately after the intervention

This evaluates pain tolerance threshold of the patients.The less score shows pain intolerance.

Secondary Outcomes

  • Hospital Anxiety and Depression Scale- HAD(baseline and immediately after the intervention)
  • Lasegue Test(baseline and immediately after the intervention)
  • Nottingham Health Profile-NHP(baseline and immediately after the intervention)
  • Digital Muscle Testing(baseline and immediately after the intervention)
  • Flexibility Measurements(baseline and immediately after the intervention)
  • ROM Assessments(baseline and immediately after the intervention)

Study Sites (1)

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