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

Istanbul University38 enrolled

Overview

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?

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Pelvic Pain Syndrome

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Istanbul University Istanbul Faculty of Medicine

Fatih, Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Visual Numeric Scale of Pain

Patients with Chronic Pelvic Pain assessed their pain levels before, right after and 1 month after treatment

Time frame: Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment

Secondary Outcomes

The Pelvic Pain Impact Questionnaire

Patients with Chronic Pelvic Pain assessed pelvic pain impact before, right after and 1 month after treatment

Time frame: 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

Time frame: 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.

Time frame: Immediately After Treatment and 1 Month After Treatment

Data from ClinicalTrials.gov

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