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

Not Applicable

Completed

• Conditions: Chronic Pelvic Pain Syndrome
• Interventions: Device: Sham TENS Stimulation; Device: Sacral TENS Stimulation

• Registration Number: NCT06099847
• Lead Sponsor: Istanbul University

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:

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?

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 Timeline

• Study Start: 2023-02-01
• Primary Completion: 2023-08-23
• Study Completion: 2023-09-15
• Status Verified: 2023-10
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-24
• Last Update Submitted: 2023-10-24
• Study First Posted: 2023-10-25
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronic Pelvic Pain Patients with Sham Stimulation	Sham TENS Stimulation	19 patients with chronic pelvic pain have been received sham stimulation intervention.
Chronic Pelvic Pain Patients with TENS	Sacral TENS Stimulation	19 patients with chronic pelvic pain have been received sacral TENS intervention.

Primary Outcome Measures

Name	Time	Method
Visual Numeric Scale of Pain	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 Outcome Measures

Name	Time	Method
The Pelvic Pain Impact Questionnaire	Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment	Patients with Chronic Pelvic Pain assessed pelvic pain impact before, right after and 1 month after treatment
Female Sexual Function Index	Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment	Patients with Chronic Pelvic Pain assessed their sexual functions before, right after and 1 month after treatment
Patient Satisfaction Questionnaire	Immediately After Treatment and 1 Month After Treatment	Patients with Chronic Pelvic Pain assessed their satisfaction levels right after and 1 month after treatment.

Trial Locations

Locations (1)

Istanbul University Istanbul Faculty of Medicine; 🇹🇷 Fatih, Istanbul, Turkey