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NCT06099847 Clinical Trial

Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: A Randomized Clinical Trial

Chronic Pelvic Pain Syndrome Clinical Trial

Official title:
Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06099847
Other study ID # 2022/1719
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date September 15, 2023

Study information
Verified date October 2023
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Is sacral transcutaneous electrical stimulation (TENS) effective to reduce/relief pain in patients with chronic pelvic pain? 2. Is the effect of TENS comparable to sham stimulation therapy in patients with chronic pelvic pain?

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date September 15, 2023
Est. primary completion date August 23, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Sham TENS Stimulation
Sacral TENS device without appropriate electrical stimulation have been applied to directly the skin of sacral area.
• Sacral TENS Stimulation
Sacral TENS stimulation have been applied to directly the skin of sacral area.

Locations
Country Name City State
Turkey Istanbul University Istanbul Faculty of Medicine Fatih Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Tirlapur 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Numeric Scale of Pain Patients with Chronic Pelvic Pain assessed their pain levels before, right after and 1 month after treatment Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment
Secondary The Pelvic Pain Impact Questionnaire Patients with Chronic Pelvic Pain assessed pelvic pain impact before, right after and 1 month after treatment Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment
Secondary Female Sexual Function Index Patients with Chronic Pelvic Pain assessed their sexual functions before, right after and 1 month after treatment Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment
Secondary Patient Satisfaction Questionnaire Patients with Chronic Pelvic Pain assessed their satisfaction levels right after and 1 month after treatment. Immediately After Treatment and 1 Month After Treatment
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