Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel with14 Essential Oils on Joint Pain of the Knee
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain visual analog analog scale is the secondary outcome
研究概览
简要总结
This clinical trial aims to evaluate the antalgic effect of Puressentiel Joints and Muscles - Gel with 14 essential oils for 12 weeks on knee joint pain in 45 patients suffering from chronic pain related to arthritis of the knee. The evaluation of the puressentiel antalgic effect Joints and Muscles - Gel with 14 essential oils will be done by an algo-functional score of WOMAC based on items of pain, joint stiffness and locomotor function (main criterion), a visual analog scale EVA (graduated from 1 to 10) of the pain by self-assessment of the patient during the consultation and the number of daily analgesics and anti-inflammatory drugs (secondary criteria).
详细描述
This clinical trial aims to evaluate the antalgic effect of Puressentiel Joints and Muscles - Gel with 14 essential oils for 12 weeks on knee joint pain in 45 patients suffering from chronic pain related to arthritis of the knee. The patients included in the study will be consultants from the Department of Physical Medicine, Rehabilitation and Sports Trauma at Foch Hospital in Suresnes and will have to present chronic pain related to arthritis of the knee either with or without antalgic and anti-inflammatory treatment. The evaluation of the puressentiel antalgic effect Joints and Muscles - Gel with 14 essential oils will be evaluated by an algo-functional score of WOMAC based on items of pain, joint stiffness and locomotor function (main criterion), a visual analog scale EVA (graduated from 1 to 10) of the pain by self-assessment of the patient during each visit and the number of daily antalgic and anti-inflammatory drugs (secondary criteria).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject smust be able to understand the terms of the written informed consent and must agree to date and sign it before any study procedure is carried out,
- •Patient having signed the informed consent
- •Aged 45 to 90
- •With chronic osteoarthritis of the knee
- •Patient with or without analgesic and anti-inflammatory treatment
排除标准
- •Patient at the stage of surgical osteoarthritis (grade 4 plus limitation of amplitude)
- •Patient with a limited walking perimeter (<100m) for any reason whatsoever
- •Patient allergic to one of the components of the study product
- •Patient not benefiting from social security
- •Patient cannot be followed for the duration of the study
- •Participation in another clinical trial within 30 days before V0
- •Subjects who cannot understand or perform study procedures.
- •Pregnant or breastfeeding women
- •People with a history of convulsive or epileptic disorders
- •People allergic to salicylates.
结局指标
主要结局
Pain visual analog analog scale is the secondary outcome
时间窗: 30 days
Scoring pain from 1 to 100 (worse)
Womac score is the primary outcome
时间窗: 30 days
Scoring pain and locomotion with a maximum score (worse of 96). A change of 16 points is considered as a significant clinical improvement
次要结局
- Pain visual analog scale(Evaluation at inclusion and after 30 days)
研究者
Marco Pacchioni
President Puressentiel laboratory
Puressentiel