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

October 24, 2023 updated by: Nalan Capan Bolukbas, Istanbul University

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Istanbul
      • Fatih, Istanbul, Turkey, 34640
        • Istanbul University Istanbul Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic Pelvic Pain Patients with TENS
19 patients with chronic pelvic pain have been received sacral TENS intervention.
Device: Sacral TENS Stimulation
Sacral TENS stimulation have been applied to directly the skin of sacral area.
Sham Comparator: Chronic Pelvic Pain Patients with Sham Stimulation
19 patients with chronic pelvic pain have been received sham stimulation intervention.
Device: Sham TENS Stimulation
Sacral TENS device without appropriate electrical stimulation have been applied to directly the skin of sacral area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Pelvic Pain Impact Questionnaire
Time Frame: 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
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
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
Patient Satisfaction Questionnaire
Time Frame: Immediately After Treatment and 1 Month After Treatment
Patients with Chronic Pelvic Pain assessed their satisfaction levels right after and 1 month after treatment.
Immediately After Treatment and 1 Month After Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Director: Nalan Capan Bolukbas, M.D., Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

August 23, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/1719

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pelvic Pain Syndrome

Clinical Trials on Sacral TENS Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe