Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women

Pelvic Pain Syndrome Clinical Trial

Official title:

Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06080828
• Other study ID #: P.T/WH/2/2023/42e
• Status: Completed
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: March 2024
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Pain
• Pelvic Pain Syndrome

Intervention

Device:
• Percutaneous Posterior Tibial Nerve Stimulation
20 minutes of neuromodulation of the posterior tibial nerve of both lower limbs using Physio Go-lite electrical stimulation device (made by ASTAR in Poland, ver 1.0.2 in Poland). Using Transcutaneous Electrical Nerve Stimulation (TENS) current in the device, the positive electrode will be placed posterior to the medial ankle malleolus, and the negative electrode will placed ten centimeters away on the leg along the tibial nerve path. The TENS current parameters will be 200 microsecond pulse width, 10 Hz frequency, and intensity according to participant tolerance ranging between (10 - 50 mA) that increased gradually until visible movement in the big toe or fanning of toes will be noticed. The therapy sessions will be given three times a week, every other day, for a total of twelve sessions.
• Placebo Percutaneous Posterior Tibial Nerve Stimulation
placebo neuromodulation of the posterior tibial nerve in both lower limbs, much as those in the research group.

Behavioral:
• Home instructions
they will receive leaflet with information for home instructions on how to properly walk, sleep, maintain good posture, and deal with activities of daily living.

Locations

Country	Name	City	State
Egypt	Kafrelshaikh University	Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS.	measurement of pain level using visual analogue scale	Before treatment and after 4 weeks of treatment
Secondary	EQ-5D-5L	EQ-5D-5L is a survey that will be used to evaluate health-related QOL	Before treatment and after 4 weeks of treatment
Secondary	serum cortisol	Early-morning serum cortisol concentration is an important biological marker for adequate pain control	Before treatment and after 4 weeks of treatment