Pelvic Pain Syndrome Clinical Trial
Official title:
Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Placebo-controlled Trial
Verified date | March 2024 |
Source | Kafrelsheikh University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | November 30, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 30 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Kafrelshaikh University | Kafr Ash Shaykh |
Lead Sponsor | Collaborator |
---|---|
Kafrelsheikh University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS. | measurement of pain level using visual analogue scale | Before treatment and after 4 weeks of treatment | |
Secondary | 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 | |
Secondary | serum cortisol | Early-morning serum cortisol concentration is an important biological marker for adequate pain control | Before treatment and after 4 weeks of treatment |
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