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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group (SG) | Experimental | 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. |
|
| control group (CG) | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Posterior Tibial Nerve Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| VAS. | measurement of pain level using visual analogue scale | Before treatment and after 4 weeks of treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
indicate if participant eligibility is based on gender identity.
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Kadry, PhD | Kafrelsheikh University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kafrelshaikh University | Kafr ash Shaykh | 12623 | Egypt |
Data from this study, including individual participant data (IPD) and associated documentation, will be made available upon reasonable request to the principal investigator. Requests will be considered when accompanied by a detailed proposal, including a clear justification for the use of the data. Such requests will be subject to a review process to ensure compatibility with participant consent and the ethical guidelines governing the study. Data sharing will be facilitated under a data use agreement that specifies the terms and conditions to ensure the privacy and confidentiality of participants
1 year from publication
Upon request from the principal investigator with appropriate justification
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| Placebo Percutaneous Posterior Tibial Nerve Stimulation | Device | placebo neuromodulation of the posterior tibial nerve in both lower limbs, much as those in the research group. |
|
| Home instructions | Behavioral | 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. |
|
| Before treatment and after 4 weeks of treatment |