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

Istanbul University1 site in 1 country38 target enrollmentFebruary 1, 2023

ConditionsChronic Pelvic Pain Syndrome

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Pelvic Pain Syndrome
Sponsor: Istanbul University
Enrollment: 38
Locations: 1
Primary Endpoint: Visual Numeric Scale of Pain
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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:

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.

Registry

clinicaltrials.gov

Start Date

February 1, 2023

End Date

September 15, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Istanbul University

Responsible Party

Principal Investigator

Nalan Capan Bolukbas

Associate Professor

Istanbul University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

The Pelvic Pain Impact Questionnaire(Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment)
Female Sexual Function Index(Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment)
Patient Satisfaction Questionnaire(Immediately After Treatment and 1 Month After Treatment)