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

Istanbul University

Status: Completed

Conditions: Chronic Pelvic Pain Syndrome

Treatments: Device: Sham TENS Stimulation; Device: Sacral TENS Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06099847

2022/1719

Details and patient eligibility

About

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?

Full 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.

Enrollment: 38 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Chronic Pelvic Pain Patients with TENS

Experimental group

Description:

19 patients with chronic pelvic pain have been received sacral TENS intervention.

Treatment:

Device: Sacral TENS Stimulation

Chronic Pelvic Pain Patients with Sham Stimulation

Sham Comparator group

Description:

19 patients with chronic pelvic pain have been received sham stimulation intervention.

Treatment:

Device: Sham TENS Stimulation