Chronic Pelvic Pain Syndrome in Males

April 13, 2024 updated by: Ugur Cavlak, Biruni University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Zeytinburnu
      • İ̇stanbul, Zeytinburnu, Turkey, 34010
        • Recruiting
        • Faculty of Health Sciences in Biruni University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

2. Receiving drug treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP I: TENS
PHYSIOTHERAPY PROGRAM PLUS TENS
Other: EXERCISE
All participants included in this group will receive Exercises
Other: TENS
All participants included in this group will receive TENS
Active Comparator: GROUP II: ESWT
PHYSIOTHERAPY PROGRAM PLUS ESWT
Other: EXERCISE
All participants included in this group will receive Exercises
Other: ESWT
All participants included in this group will receive ESWT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VISUAL ANALOUGE SCALE
Time Frame: baseline and immediately after the intervention
It evaluates pain intensity grading between 0-10. Higher score shows severe pain.
baseline and immediately after the intervention
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.
baseline and immediately after the intervention
ALGOMETER
Time Frame: baseline and immediately after the intervention
This evaluates pain tolerance threshold of the patients.The less score shows pain intolerance.
baseline and immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale- HAD
Time Frame: 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.
baseline and immediately after the intervention
Nottingham Health Profile-NHP
Time Frame: 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.
baseline and immediately after the intervention
Digital Muscle Testing
Time Frame: baseline and immediately after the intervention
To evaluate muscles's strenght using by Power Track. Higher cosre shows good strneght.
baseline and immediately after the intervention
Flexibility Measurements
Time Frame: 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.
baseline and immediately after the intervention
ROM Assessments
Time Frame: baseline and immediately after the intervention
To measure range of motion of the joints by using goniometer.
baseline and immediately after the intervention
Lasegue Test
Time Frame: baseline and immediately after the intervention
To measure flexibility of the sciatic nerve, manually.
baseline and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biruni University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

April 4, 2024

Study Completion (Estimated)

August 15, 2024

Study Registration Dates

First Submitted

March 29, 2024

First Submitted That Met QC Criteria

April 13, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BiruniUniver

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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