Chronic Pelvic Pain SyndromeNCT06099847
Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: A Randomized Clinical Trial
A study testing Sacral TENS Stimulation in people with Chronic Pelvic Pain Syndrome, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this interventional study is to test of efficacy of sacral Transcutaneous Electrical Stimulation (TENS) in patients with chronic pelvic pain. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Chronic Pelvic Pain Syndrome
- What is being tested?
- Sacral TENS Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 15 Sep 2023
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female with chronic pelvic pain for ≥6 months
- 18-65 years old
- Visual Numeric Scale of Pain score ≥4/10
- Voluntarily participate to the study
Who cannot join
- Pregnancy
- Having severe medical and/or psychiatric disorder
- Malignancy
- Chronic infection
- Inflammatory musculoskeletal system disease
- Skin infection in sacral/pelvic area
- Having implanted neuromodulatory device (such as pacemaker or defibrillator)
- Refusing to participate the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine
Fatih, Istanbul, 34640
About this study
The goal of this interventional study is to test of efficacy of sacral Transcutaneous Electrical Stimulation (TENS) in patients with chronic pelvic pain.
The main questions it aims to answer are:
- Is sacral transcutaneous electrical stimulation (TENS) effective to reduce/relief pain in patients with chronic pelvic pain?
- Is the effect of TENS comparable to sham stimulation therapy in patients with chronic pelvic pain?
Read the detailed description
Our study aiming to test the efficacy of sacral transcutaneous electrical stimulation (TENS) intervention in patients with chronic pelvic pain. We aim to test the efficacy and compare it with sham stimulation therapy in chronic pelvic pain.
- Conditions
- Chronic Pelvic Pain Syndrome
- Being tested
- Sham TENS Stimulation, Sacral TENS Stimulation
- Keywords
- transcutaneous electrical stimulation, chronic pelvic pain, sacral, randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham TENS StimulationDevice
Sacral TENS device without appropriate electrical stimulation have been applied to directly the skin of sacral area.
Sacral TENS StimulationDevice
Sacral TENS stimulation have been applied to directly the skin of sacral area.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Pelvic Pain Patients with TENS | Experimental | 19 patients with chronic pelvic pain have been received sacral TENS intervention. Receives: Device: Sacral TENS Stimulation |
| Chronic Pelvic Pain Patients with Sham Stimulation | Sham comparator | 19 patients with chronic pelvic pain have been received sham stimulation intervention. Receives: Device: Sham TENS Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Numeric Scale of Pain
Patients with Chronic Pelvic Pain assessed their pain levels before, right after and 1 month after treatment
Measured: Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment
Secondary outcomes (3)
The Pelvic Pain Impact Questionnaire
Patients with Chronic Pelvic Pain assessed pelvic pain impact before, right after and 1 month after treatment
Measured: Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment
Female Sexual Function Index
Patients with Chronic Pelvic Pain assessed their sexual functions before, right after and 1 month after treatment
Measured: Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment
Patient Satisfaction Questionnaire
Patients with Chronic Pelvic Pain assessed their satisfaction levels right after and 1 month after treatment.
Measured: Immediately After Treatment and 1 Month After Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Feb 2023
- Primary completion23 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- We aim to compare sacral TENS in patients with chronic pelvic pain and compare it with sham stimulation therapy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nalan Capan Bolukbas, Istanbul University
- Investigators
- Nalan Capan Bolukbas, M.D., Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099847
- Sponsor's protocol ID
- 2022/1719
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arik MI, Kiloatar H, Aslan B, Icelli M. The effect of TENS for pain relief in women with primary dysmenorrhea: A systematic review and meta-analysis. Explore (NY). 2022 Jan-Feb;18(1):108-113. doi: 10.1016/j.explore.2020.08.005. Epub 2020 Aug 29.
PubMed 32917532Tirlapur SA, Vlismas A, Ball E, Khan KS. Nerve stimulation for chronic pelvic pain and bladder pain syndrome: a systematic review. Acta Obstet Gynecol Scand. 2013 Aug;92(8):881-7. doi: 10.1111/aogs.12184. Epub 2013 Jun 22.
PubMed 23710833
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06099847
- Acronym / sponsor ID
- 2022/1719
- Conditions
- Chronic Pelvic Pain Syndrome
- Keywords
- transcutaneous electrical stimulation, chronic pelvic pain, sacral, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 25 Oct 2023 (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 goal of this interventional study is to test of efficacy of sacral Transcutaneous Electrical Stimulation (TENS) in patients with chronic pelvic pain.
The main questions it aims to answer are:
- Is sacral transcutaneous electrical stimulation (TENS) effective to reduce/relief pain in patients with chronic pelvic pain?
- Is the effect of TENS comparable to sham stimulation therapy in patients with chronic pelvic pain?
Detailed description
Our study aiming to test the efficacy of sacral transcutaneous electrical stimulation (TENS) intervention in patients with chronic pelvic pain. We aim to test the efficacy and compare it with sham stimulation therapy in chronic pelvic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- We aim to compare sacral TENS in patients with chronic pelvic pain and compare it with sham stimulation therapy.
| Arm | Type | Receives |
|---|---|---|
| Chronic Pelvic Pain Patients with TENS | Experimental | Device: Sacral TENS Stimulation19 patients with chronic pelvic pain have been received sacral TENS intervention. |
| Chronic Pelvic Pain Patients with Sham Stimulation | Sham comparator | Device: Sham TENS Stimulation19 patients with chronic pelvic pain have been received sham stimulation intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female with chronic pelvic pain for ≥6 months
- 18-65 years old
- Visual Numeric Scale of Pain score ≥4/10
- Voluntarily participate to the study
Key exclusion criteria (8 listed)
- Pregnancy
- Having severe medical and/or psychiatric disorder
- Malignancy
- Chronic infection
- Inflammatory musculoskeletal system disease
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 |
|---|---|---|
| Sham TENS StimulationSacral TENS device without appropriate electrical stimulation have been applied to directly the skin of sacral area. | Device | Chronic Pelvic Pain Patients with Sham Stimulation |
| Sacral TENS StimulationSacral TENS stimulation have been applied to directly the skin of sacral area. | Device | Chronic Pelvic Pain Patients with TENS |
Primary outcome
Visual Numeric Scale of Pain
Time frame: Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment
Patients with Chronic Pelvic Pain assessed their pain levels before, right after and 1 month after treatment
3 secondary outcomes
The Pelvic Pain Impact Questionnaire
Time frame: Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment
Female Sexual Function Index
Time frame: Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment
Patient Satisfaction Questionnaire
Time frame: Immediately After Treatment and 1 Month After Treatment
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 25 Oct 2023.
- Results publication: PubMed 32917532Arik MI, Kiloatar H, Aslan B, Icelli M. The effect of TENS for pain relief in women with primary dysmenorrhea: A systematic review and meta-analysis. Explore (NY). 2022 Jan-Feb;18(1):108-113. doi: 10.1016/j.explore.2020.08.005. Epub 2020 Aug 29.
- Results publication: PubMed 23710833Tirlapur SA, Vlismas A, Ball E, Khan KS. Nerve stimulation for chronic pelvic pain and bladder pain syndrome: a systematic review. Acta Obstet Gynecol Scand. 2013 Aug;92(8):881-7. doi: 10.1111/aogs.12184. Epub 2013 Jun 22.
- Main ReferenceLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Pelvic Pain Syndrome
Not yet recruiting
Focused Ultrasound Neuromodulation for Chronic Pain
Chronic Pain, Sickle Cell Disease
Not yet recruiting
Pregabalin for Chronic Pelvic Pain in Women
Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome
Recruiting
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
Chronic Pelvic Pain Syndrome, Pelvic Pain
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome
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.
Nalan Capan Bolukbas, M.D. study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral TENS Stimulation in people with Chronic Pelvic Pain Syndrome, run by Istanbul 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 4 inclusion and 8 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 25 Oct 2023. 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. Some participants in this study may receive a placebo. 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 Numeric Scale of Pain (time frame: Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment). 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 NCT06099847, which also lists 2 linked publications.
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 25 Oct 2023.