Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- VAS.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nulliparous, with a body mass index not exceeding 30 kg/m2 and complaining of idiopathic chronic pelvic pain syndrome (CPP).
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Placebo Percutaneous Posterior Tibial Nerve Stimulation (Device)
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.
干预措施: Percutaneous Posterior Tibial Nerve Stimulation (Device)
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.
干预措施: Home instructions (Behavioral)
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.
干预措施: Home instructions (Behavioral)
结局指标
主要结局
VAS.
时间窗: Before treatment and after 4 weeks of treatment
measurement of pain level using visual analogue scale
次要结局
- EQ-5D-5L(Before treatment and after 4 weeks of treatment)
- serum cortisol(Before treatment and after 4 weeks of treatment)
研究者
Ahmed Mahmoud Kadry
Associate Professor of Physical Therapy
Kafrelsheikh University