Chronic Pelvic Pain Syndrome in Males

Pelvic Pain Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06369545
• Other study ID #: BiruniUniver
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: August 15, 2024

Study information

• Verified date: April 2024
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: August 15, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Pain
• Pelvic Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Other:
• EXERCISE
All participants included in this group will receive Exercises
• TENS
All participants included in this group will receive TENS
• ESWT
All participants included in this group will receive ESWT

Locations

Country	Name	City	State
Turkey	Faculty of Health Sciences in Biruni University	I?stanbul	Zeytinburnu

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VISUAL ANALOUGE SCALE	It evaluates pain intensity grading between 0-10. Higher score shows severe pain.	baseline and immediately after the intervention
Primary	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
Primary	ALGOMETER	This evaluates pain tolerance threshold of the patients.The less score shows pain intolerance.	baseline and immediately after the intervention
Secondary	Hospital Anxiety and Depression Scale- HAD	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
Secondary	Nottingham Health Profile-NHP	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
Secondary	Digital Muscle Testing	To evaluate muscles's strenght using by Power Track. Higher cosre shows good strneght.	baseline and immediately after the intervention
Secondary	Flexibility Measurements	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
Secondary	ROM Assessments	To measure range of motion of the joints by using goniometer.	baseline and immediately after the intervention
Secondary	Lasegue Test	To measure flexibility of the sciatic nerve, manually.	baseline and immediately after the intervention