Clinical trial NCT06099847: Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: A Randomized Clinical Trial
Official title: Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pelvic Pain Syndrome
Keywords: transcutaneous electrical stimulation
chronic pelvic pain
sacral
randomized clinical trial
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We aim to compare sacral TENS in patients with chronic pelvic pain and compare it with sham stimulation therapy.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Numeric Scale of Pain
timeFrame: Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment
Secondary outcomes:
measure: The Pelvic Pain Impact Questionnaire
timeFrame: Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment
measure: Female Sexual Function Index
timeFrame: Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment
measure: Patient Satisfaction Questionnaire
timeFrame: Immediately After Treatment and 1 Month After Treatment
Other outcomes:
Locations:
city: Fatih
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine
state: Istanbul
Study officials:
affiliation: Istanbul University
name: Nalan Capan Bolukbas, M.D.
role: STUDY_DIRECTOR
References:
citation: Arik MI, Kiloatar H, Aslan B, Icelli M. The effect of TENS for pain relief in women with primary dysmenorrhea: A systematic review and meta-analysis. Explore (NY). 2022 Jan-Feb;18(1):108-113. doi: 10.1016/j.explore.2020.08.005. Epub 2020 Aug 29.
citation: Tirlapur SA, Vlismas A, Ball E, Khan KS. Nerve stimulation for chronic pelvic pain and bladder pain syndrome: a systematic review. Acta Obstet Gynecol Scand. 2013 Aug;92(8):881-7. doi: 10.1111/aogs.12184. Epub 2013 Jun 22.