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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pelvic Pain Syndrome

Intervention / Treatment
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* Device: Sham TENS Stimulation
* Device: Sacral TENS Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We aim to compare sacral TENS in patients with chronic pelvic pain and compare it with sham stimulation therapy.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Numeric Scale of Pain | 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 | 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 | 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 | Patients with Chronic Pelvic Pain assessed their satisfaction levels right after and 1 month after treatment. | Immediately After Treatment and 1 Month After Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sacral, transcutaneous electrical stimulation, chronic pelvic pain, randomized clinical trial