Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Placebo-controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pelvic Pain Syndrome
- Sponsor
- Kafrelsheikh University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- VAS.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Ahmed Mahmoud Kadry
Associate Professor of Physical Therapy
Kafrelsheikh University
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
Outcomes
Primary Outcomes
VAS.
Time Frame: Before treatment and after 4 weeks of treatment
measurement of pain level using visual analogue scale
Secondary Outcomes
- EQ-5D-5L(Before treatment and after 4 weeks of treatment)
- serum cortisol(Before treatment and after 4 weeks of treatment)