Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Controlled Trial

Conditions
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Pelvic Pain Syndrome

Intervention / Treatment
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* Device: Percutaneous Posterior Tibial Nerve Stimulation
* Device: Placebo Percutaneous Posterior Tibial Nerve Stimulation
* Behavioral: Home instructions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group (SG)<br>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. | Device: Percutaneous Posterior Tibial Nerve Stimulation<br>* 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.<br>Behavioral: Home instructions<br>* 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.<br>|
| Placebo Comparator: control group (CG)<br>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. | Device: Placebo Percutaneous Posterior Tibial Nerve Stimulation<br>* placebo neuromodulation of the posterior tibial nerve in both lower limbs, much as those in the research group.<br>Behavioral: Home instructions<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS. | measurement of pain level using visual analogue scale | Before treatment and after 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| serum cortisol | Early-morning serum cortisol concentration is an important biological marker for adequate pain control | Before treatment and after 4 weeks of treatment |