Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women

Not Applicable

Completed

• Conditions: Pelvic Pain Syndrome

• Registration Number: NCT06080828
• Lead Sponsor: Kafrelsheikh University

Brief Summary

Background: Chronic pelvic pain (CPP) significantly impacts the quality of life in women. This study investigated the effects of transdermal neuromodulation in females with CPP.

Trial Design: Parallel, randomized, single-blind, controlled trial The aim of the study will be to examine the effect of posterior tibial nerve stimulation on women with idiopathic chronic pelvic pain syndrome.

Methods: Thirty females with chronic pelvic pain will be randomly allocated 1:1 to receive either transdermal neuromodulation of the posterior tibial nerve (intervention group) or advice to control posture (control group) for 4 weeks at the Outpatient Physical Therapy Clinic at Kafrelsheikh University in Egypt. The primary outcome was pain intensity measured by visual analog scale (VAS). Secondary outcomes were serum cortisol level and quality of life (QOL) score. Assessments will be done at baseline and after 4 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-10-08
• Study First Submitted QC: 2023-10-08
• Study First Posted: 2023-10-12
• Primary Completion: 2023-10-30
• Study Completion: 2023-11-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

• nulliparous, with a body mass index not exceeding 30 kg/m2 and complaining of idiopathic chronic pelvic pain syndrome (CPP).

Exclusion Criteria

• chronic uterine prolapse, endometriosis, pelvic tumor, any sexual problems, an active genitourinary infection, heart diseases, kidney diseases, cognitive disorders or any physical or psychological condition that might impair the ability to provide written informed consent or adhere to the research procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VAS.	Before treatment and after 4 weeks of treatment	measurement of pain level using visual analogue scale

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L	Before treatment and after 4 weeks of treatment	EQ-5D-5L is a survey that will be used to evaluate health-related QOL
serum cortisol	Before treatment and after 4 weeks of treatment	Early-morning serum cortisol concentration is an important biological marker for adequate pain control

Trial Locations

Locations (1)

Kafrelshaikh University; 🇪🇬 Kafr Ash Shaykh, Egypt