Randomized Clinical Investigation to Assess Preliminary Clinical Performance, Effectiveness and Safety of the LumbaCure® (prototype C190070.01) Medical Device When Used in Patients Suffering from Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Disability
研究概览
简要总结
Low Back Pain (LBP) is one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020. LBP has been the leading cause of years lived with disability from 1990 to 2017. The highest incidence of LBP is in people in their third decade of age. LBP is a complex disease difficult to treat as most of these cases (80 - 90 %) are classified as non-specific meaning that the pain cannot be attributed to any specific injury or pathology.
Until now exercise therapy is commonly used as the treatment of choice in the revalidation program of LBP. The aim of physical treatment is to improve function and prevent disability from getting worse.
LumbaCure® is a robotic system driven by a proprietary movement algorithm to induce a specific and controlled mobilization of the hips and the low back in patient requiring treatment by physical exercises due to orthopedic disorder, especially low back pain.
The investigation include an intervention period of 4 weeks The main objective is to compare the impact on disability (Oswestry disability Index) and movement performance of the interventions (LumbaCure® vs physical exercises supervised by the physiotherapist) in two parallel groups of patients suffering from chronic low back pain.
The investigation includes an intervention period of 4 weeks and a follow-up period of 6 months (post intervention period).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic non-specific LBP (without red flag)
- •Patient did not increase, on a long-term basis, his/her regular physical activity in the past 2 months.
- •LBP is the principal musculoskeletal condition
- •Aged between 18 and 65 years old
- •Able to read and understand questionnaires and communicate with the physiotherapist.
- •Average Back Pain intensity over the last week above 2, assessed on Numerical Pain Rating Scale from 0 to 10 anchored with "no pain" at 0 and "worst pain imaginable " at
- •ODI score > 20
排除标准
- •Suspected or confirmed serious pathology (i.e infection, fracture, cancer, inflammatory arthritis, ….)
- •Radicular pain
- •Radiculopathy
- •Cognitive impairment that precludes participant from consenting, completing investigation questionnaires or complying with recommendations
- •Previous spine surgery in the last 3 months
- •Pregnant women
- •body weight > 120 kg
- •Neurological disease
- •Fibromyalgia
结局指标
主要结局
Disability
时间窗: Baseline, week 4 (end of intervention period)
The change of the Oswestry Disability Index (ODI) between baseline and the end of the intervention period (4 weeks)
次要结局
- Disability(week2 (intervention period); month 1, month 3 and month 6 follow-up period)
- Back Pain responding rate(week 2, week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period))
- Disability responding rate(week 2, week 4 (intervention period) and at month 1, month 3 and month 6 follow-up period)
- Kinesiophobia(month 1, month 3 and 6 (follow-up period))
- Anxiety and depression(month 1, month 3 and 6 (follow-up period))
- Physiotherapist global satisfaction(week 4)
- Back Pain(month 1, month 3 and month 6 (follow-up period))
- Function(Between end of intervention period and month 1, month 3 and 6 post-intervention)
- Function responding rate(week 4 (intervention period) and at month 1, month 3 and month 6 (follow-up period))
- Kinesiophobia responding rate(week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period))
- Anxiety and depression responding rate(week 4 (intervention period) and month 1, month 3 and month 6 (follow-up period))
- Patient global satisfaction of the therapy(End of intervention period (week 4))