NCT06080828

Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: Female
• Age: 20 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pelvic Pain Syndrome

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-10-30
• Completion: 2023-11-30
• First posted: 2023-10-12
• Last updated: 2024-03-25

Locations

1 site across 1 country: Egypt