Chronic Pelvic Pain Syndrome in Males

October 15, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Faculty of Health Sciences in Biruni University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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