Pelvic Pain SyndromeNCT06369545
Chronic Pelvic Pain Syndrome in Males
A study testing EXERCISE, TENS and ESWT in people with Pelvic Pain Syndrome, run by Biruni University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Pelvic Pain Syndrome
- What is being tested?
- EXERCISE, TENS and ESWT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 20-40 years old males
- Diagnosis of Chronic Pelvic Pain Syndrome
Who cannot join
- Cancer
- Surgery related to pelvic floor
- 2. Receiving drug treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences in Biruni University
Istanbul, Zeytinburnu, 34010
About this study
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
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.
Read the 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).
- Conditions
- Pelvic Pain Syndrome
- Being tested
- EXERCISE, TENS, ESWT
- Keywords
- Chronic Pelvic Pain Syndrome, Male, ESWT, TENS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISEOther
All participants included in this group will receive Exercises
TENSOther
All participants included in this group will receive TENS
ESWTOther
All participants included in this group will receive ESWT
| Study group | Role | What they receive |
|---|---|---|
| GROUP I: TENS | Experimental | PHYSIOTHERAPY PROGRAM PLUS TENS Receives: Other: EXERCISE; Other: TENS |
| GROUP II: ESWT | Active comparator | PHYSIOTHERAPY PROGRAM PLUS ESWT Receives: Other: EXERCISE; Other: ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISUAL ANALOUGE SCALE
It evaluates pain intensity grading between 0-10. Higher score shows severe pain.
Measured: 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.
Measured: baseline and immediately after the intervention
ALGOMETER
This evaluates pain tolerance threshold of the patients.The less score shows pain intolerance.
Measured: baseline and immediately after the intervention
Secondary outcomes (6)
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.
Measured: baseline and immediately after the intervention
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.
Measured: baseline and immediately after the intervention
Digital Muscle Testing
To evaluate muscles's strenght using by Power Track. Higher cosre shows good strneght.
Measured: baseline and immediately after the intervention
Flexibility Measurements
To measure flexibility of the muscles, manually. The amount of elasticity is measured and the result is recorded in cm.
Measured: baseline and immediately after the intervention
ROM Assessments
To measure range of motion of the joints by using goniometer.
Measured: baseline and immediately after the intervention
Lasegue Test
To measure flexibility of the sciatic nerve, manually.
Measured: baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jan 2024
- Primary completion4 Apr 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ugur Cavlak, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369545
- Sponsor's protocol ID
- BiruniUniver
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23433012
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06369545
- Acronym / sponsor ID
- BiruniUniver
- Conditions
- Pelvic Pain Syndrome
- Keywords
- Chronic Pelvic Pain Syndrome, Male, ESWT, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controled Trial
| Arm | Type | Receives |
|---|---|---|
| GROUP I: TENS | Experimental | Other: EXERCISE, Other: TENSPHYSIOTHERAPY PROGRAM PLUS TENS |
| GROUP II: ESWT | Active comparator | Other: EXERCISE, Other: ESWTPHYSIOTHERAPY PROGRAM PLUS ESWT |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged between 20-40 years old males
- Diagnosis of Chronic Pelvic Pain Syndrome
Key exclusion criteria (3 listed)
- Cancer
- Surgery related to pelvic floor
- 2. Receiving drug treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXERCISEAll participants included in this group will receive Exercises | Other | GROUP I: TENS, GROUP II: ESWT |
| TENSAll participants included in this group will receive TENS | Other | GROUP I: TENS |
| ESWTAll participants included in this group will receive ESWT | Other | GROUP II: ESWT |
Primary outcome
VISUAL ANALOUGE SCALE
Time frame: baseline and immediately after the intervention
It evaluates pain intensity grading between 0-10. Higher score shows severe pain.
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.
ALGOMETER
Time frame: baseline and immediately after the intervention
This evaluates pain tolerance threshold of the patients.The less score shows pain intolerance.
6 secondary outcomes
Hospital Anxiety and Depression Scale- HAD
Time frame: baseline and immediately after the intervention
Nottingham Health Profile-NHP
Time frame: baseline and immediately after the intervention
Digital Muscle Testing
Time frame: baseline and immediately after the intervention
Flexibility Measurements
Time frame: baseline and immediately after the intervention
ROM Assessments
Time frame: baseline and immediately after the intervention
Lasegue Test
Time frame: baseline and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 23433012Schneider 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE, TENS and ESWT in people with Pelvic Pain Syndrome, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VISUAL ANALOUGE SCALE (time frame: baseline and immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06369545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.