Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Controlled Trial
Pelvic Pain Syndrome
About this trial
This is an interventional treatment trial for Pelvic Pain Syndrome
Eligibility Criteria
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
Sites / Locations
- Kafrelshaikh University
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
study group (SG)
control group (CG)
they will receive treatment with 20 minutes of neuromodulation of the posterior tibial nerve of both lower limbs using Physio Go-lite electrical stimulation device (made by ASTAR, ver 1.0.2 in Poland). Using 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 micro second 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. Alos, 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.
They will receive placebo neuromodulation of the posterior tibial nerve in both lower limbs, much as those in the research group. Alos, 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.