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Completed

NCT Number: NCT06099847

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

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?

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Key information

Conditions

Chronic Pelvic Pain Syndrome

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Istanbul Faculty of Medicine

Fatih, Istanbul, 34640, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham TENS Stimulation

Device

Sacral TENS device without appropriate electrical stimulation have been applied to directly the skin of sacral area.

Sacral TENS Stimulation

Device

Sacral TENS stimulation have been applied to directly the skin of sacral area.

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2023
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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