Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Controlled Trial
Study Details
Study Description
Brief Summary
Background: Chronic pelvic pain (CPP) significantly impacts 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 amies of the study will be to examine the effect of posterior tibial nerve stimulation of 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: study group (SG) 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
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.
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.
|
| Placebo Comparator: control group (CG) 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
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.
|
Outcome Measures
Primary Outcome Measures
- VAS. [Before treatment and after 4 weeks of treatment]
measurement of pain level using visual analogue scale
Secondary Outcome Measures
- EQ-5D-5L [Before treatment and after 4 weeks of treatment]
health survey was used to evaluate health-related QOL
- serum cortisol [Before treatment and after 4 weeks of treatment]
Early-morning serum cortisol concentration is an important biological marker for adequate pain control
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kafrelshaikh University | Kafr Ash Shaykh | Egypt | 12623 |
Sponsors and Collaborators
- Kafrelsheikh University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P.T/WH/2/2023/42