NCT06203886已完成不适用
Exploratory Clinical Investigation of the LumbaCure® Medical Device Used in Elderly People Suffering From Chronic Low Back Pain.
Odix2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年12月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Low back pain
研究概览
简要总结
The goal of this investigation is to evaluate the safety and efficacy of the LumbaCure® device in elderly people suffering from low back pain. The study is being carried out at several sites, in nursing homes, in order to reach the elderly patients most at risk of a sedentary lifestyle.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic or sub-acute low back pain (without "red flag")
- •The subject, a resident or worker at the investigation site (nursing home), over 60 years of age
- •Ability to communicate with the physiotherapist.
- •Ability to remain in a sitting position for at least 10 minutes.
- •A level of back pain > 2 on the numerical pain rating scale
排除标准
- •Suspected or confirmed serious pathology (infection, fracture, cancer, inflammatory arthritis, ....) related to the back/spine.
- •Body weight > 120 kg
- •Subject is non-ambulatory or has severely reduced mobility.
- •Dominant component of radicular pain (common lumbago with distal radiation below the knee)
- •Radiculopathy
- •Severe cardiorespiratory disease
- •Dementia or significant cognitive impairment that prevents the participant from giving consent, completing study questionnaires or complying with recommendations.
- •Fracture or operation less than 3 months old of the spine, pelvis, hip or leg bones.
- •Known vertebral pathology other than osteoarthritis.
- •Major neurological disease, movement or motor neuron disorders
- •Fibromyalgia or other systemic rheumatic disease
- •Recent history of stroke or heart failure, unstable heart condition
- •Uncontrolled substance abuse disorders
- •Invasive procedures to relieve pain in the last 3 months
- •Acute or terminal illness
- •Any other medical condition considered by the study team to be a contraindication to the study.
结局指标
主要结局
Low back pain
时间窗: Change between baseline and Visit 3 (Day 28)
Mean intensity of low back pain during the last week, assessed on a numerical pain rating scale from 0 to 10
次要结局
- Functional mobility(Follow-up period : between the end of the investigation period and 1 month post-study (Day 56 - Visit 4))
- Low back pain(Follow-up : Between end of the investigation period [Day 28] and 1 month post-study.)
- Overall satisfaction of the physiotherapist with the LumbaCure® intervention(End of intervention period [Day 28])
- Overall patient satisfaction with the LumbaCure® intervention(End of intervention period [Day 28])
- Risk of falling(Between the end of the investigation,visit 3 [Day 28] and one month follow-up)
研究者
研究点 (2)
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