A Pilot Randomized Trial Comparing the Use of MILTA vs Placebo for the Management of Pain Related to Perineal Scars Following Delivery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- pain level
研究概览
简要总结
The incidence of perineal scars after a pregnancy is high, either related to an episiotomy or to spontaneous perineal tears. These perineal scars can result in acute pain but also in chronic pain for some women. Medical treatment includes level 1 and 2 analgesics and, even for a few women, level 3 analgesic.
The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain : 1- The NPCL (Nano-Pulsed Cold Laser) emissions in coherent infrared light, at 905 nanometers; 2- Non-coherent emissions, pulsed by trichromatic RGB CSM diodes (400 to 650 nm); 3- Continuous non-coherent infrared emission monochromatic diodes at 905 nm; 4- A constant circular magnetic field (200 millitesla) equivalent to the terrestrial magnetic field and 5- The effect of magnetic tunnel which potentiates the light propagation. MILTA® treatment has been shown to be effective in various managements of pain, but has never been used in pain related to perineal scars.
This randomized controlled trial aims at assessing MILTA vs placebo to reduce pain related to perineal scars after pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •vaginal delivery less than 24h before inclusion
- •perineal scar with pain assessed as > 3/10 with a numerical scale
- •18-years-old or older
- •registration to the French medical system
- •speaking and writing French
- •written informed consent signed
排除标准
- •woman under 18-years-old
- •woman under law liberty restriction
- •women unable to understand the written informed consent
- •no written informed consent signed
- •previous perineal surgery
- •delivery with a caesarian section
- •vaginal delivery with no perineal scar
- •vaginal delivery with infected perineal scar
- •women with restrictions for the use of level 1 analgesic
- •women requiring level 2 or 3 analgesics for other reasons
结局指标
主要结局
pain level
时间窗: day 3
Pain Level will be determined with EQ-5D instrument. The EQ-5D index scores were derived from the current UK tariff, which has a maximum value of 1 and a minimum value of -0.59. EQ-5D comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding.
次要结局
未报告次要终点