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Completed

NCT Number: NCT06369545

Chronic Pelvic Pain Syndrome in Males

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.

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Key information

Conditions

Pelvic Pain Syndrome

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences in Biruni University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Cancer
  • Surgery related to pelvic floor
  • Receiving drug treatment

Treatment and study plan

Exercise

Other

All participants included in this group will receive Exercises

TENS

Other

All participants included in this group will receive TENS

ESWT

Other

All participants included in this group will receive ESWT

Primary outcomes

  1. VISUAL ANALOUGE SCALE

    Time frame: baseline and immediately after the intervention

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

  2. 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.

  3. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. ROM Assessments

    Time frame: baseline and immediately after the intervention

    To measure range of motion of the joints by using goniometer.

  6. Lasegue Test

    Time frame: baseline and immediately after the intervention

    To measure flexibility of the sciatic nerve, manually.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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