Chronic Pelvic Pain Syndrome in Males

NCT06369545 | Completed

• 1 other identifier: BiruniUniver
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain Syndrome

Keywords

Chronic Pelvic Pain Syndrome; Male; ESWT; TENS

Outcome Measures

Primary Outcomes (3)

• VISUAL ANALOUGE SCALE

  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)

  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

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

  baseline and immediately after the intervention

Secondary Outcomes (6)

• Hospital Anxiety and Depression Scale- HAD

  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 Arms (2)

GROUP I: TENS

EXPERIMENTAL

PHYSIOTHERAPY PROGRAM PLUS TENS

Other: EXERCISE; Other: TENS

GROUP II: ESWT

ACTIVE COMPARATOR

PHYSIOTHERAPY PROGRAM PLUS ESWT

Other: EXERCISE; Other: ESWT

Interventions

EXERCISE OTHER

All participants included in this group will receive Exercises

GROUP I: TENS; GROUP II: ESWT

TENS OTHER

All participants included in this group will receive TENS

GROUP I: TENS

ESWT OTHER

All participants included in this group will receive ESWT

GROUP II: ESWT

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Faculty of Health Sciences in Biruni University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Related Publications (1)

• Schneider MP, Tellenbach M, Mordasini L, Thalmann GN, Kessler TM. Refractory chronic pelvic pain syndrome in men: can transcutaneous electrical nerve stimulation help? BJU Int. 2013 Jul;112(2):E159-63. doi: 10.1111/bju.12005. Epub 2013 Feb 22.

  PMID: 23433012 BACKGROUND

MeSH Terms

Interventions

Exercise; Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Randomized Controled Trial

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 17, 2024
• Study Start: January 1, 2024
• Primary Completion: April 4, 2024
• Study Completion: August 15, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)