Evaluation of the Comfort Increase Provided by an Additional Foam Pad on a Lumbar Belt "Cellacare Lumbal Classic - Lohmann & Rauscher" and Its Biophysical Impact
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Comfort
研究概览
简要总结
The spine is the central musculoskeletal system of the back. It carries and supports a major part of the body weight and ensures simultaneously the trunk's mobility, particularly the mobility of the lumbar spine and the head's mobility by moving the cervical spine. Back pain in the lumbar spine area is the most common kind of pain with a prevalence of 60 to 70 per cent in industrialized countries (Jellema2001).
详细描述
Back orthosis permits temporary support and stress reduction (in terms of load) of the concerned structures and first of all intervertebral disks. The aim of this study is to evaluate the comfort variation with and without the additional back insert, with the hypothesis that a more comfortable lumbar belt would improve the care observance. This study also aims to verify the relevancy of objective indicators such as pressure measurement and disk hydration for the added benefice of the back insert.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer, men or women, aged 18 to 50 years old without lumbar pathology.
- •Volunteer beneficiary of a social security scheme.
- •Volunteer informed about the study and having co-signed a consent form to participate to the study with the investigator
排除标准
- •Protected persons
- •Pregnant or breastfeeding women
- •Persons deprived of freedom, hospitalised without consent, hospitalised with other ends then research.
- •Adults under legal protection (protection of vulnerable adults) or not able to express consent.
- •Persons showing gait difficulties (test on treadmill) or with neurological/joint pathologies promoting falls (Parkinson, hemiplegia, …)
- •Patient seen by a doctor for lumbar pain in the 2 months prior to the inclusion.
- •Patient suffering from scoliosis
- •Refusal of consent
- •Contraindication to MRI
- •Patient carrying an internal electronic device (pacemaker, neurostimulator, insulin pump…)
- •Patient with known allergies to one of the product components (e.g. latex)
- •During the first MRI, volunteers showing prior signs of lower back pain or discopathy will be excluded.
研究组 & 干预措施
Experimental group with additional back insert of a lumbar belt
Additional back insert of a lumbar belt
干预措施: MRI evening 1 (Device)
Control group with lumbar belt
a lumbar belt
干预措施: MRI evening 2 (Device)
Control group without lumbar belt
without lumbar belt
干预措施: MRI (Device)
结局指标
主要结局
Comfort
时间窗: Day1
Comfort is measuring with a scale : 0 = uncomfortable, 10 = extremely comfortable
次要结局
未报告次要终点