Pilot Study to Assess the Efficacy of the ATLAS Medical Device on Pain in Patients With Subacute or Chronic Low Back Pain With Lumbar Disc Disease: Prospective, Randomized Trial (AmbuTract)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Evolution of the lumbar pain
研究概览
简要总结
Monocentric, comparative, randomized, controlled interventionnal study in 2 parallel groups, aiming to compare the efficacy of the ATLAS device with that of a standard lumbar belt on the reduction of pain felt in patients with subacute or chronic low back pain with lumbar disc disease.
详细描述
The main expected benefit is a reduction in pain experienced in patients with subacute or chronic low back pain during and after wear. Consequently, an improvement in the quality of daily life is expected with a less significant impact of low back pain.
The main objective of the study is to compare the efficacy of the ATLAS medical device with a standard lumbar support belt in terms of immediate reduction of low back pain experienced in patients with subacute or chronic low back pain.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from subacute (for 6 to 12 weeks) or chronic (> 3 months) lumbar pain;
- •Lumbar disc disease confirmed by Magnetic Resonance Imaging (MRI) less than 3 months old;
- •Patient with lumbar pain ≥ 40mm on the visual analogue scale (VAS) at inclusion;
- •Patient in whom a lumbar belt / restraint is considered for a short period to help resumption of activity;
- •Patient with internet and a camera (by phone or computer) and agreeing to use them as part of the study's teleconsultations;
- •Patient capable of understanding the information related to the study (absence of linguistic, psychological, cognitive problem, etc.), of reading the information leaflet, of completing questionnaires and agreeing to sign the consent form.
排除标准
- •Patient with neurological radicular or medullary deficits;
- •Patient presenting a postural problem with lateralized contracture;
- •Skin pathology in the trunk region and / or contusions and injuries by stretching the trunk;
- •History of spinal arthrodesis surgery;
- •History of cauda equina syndrome;
- •Patient treated by implanted neurostimulation;
- •Scoliosis with Cobb angle> 30 °;
- •History of recent fracture of the dorsolumbar spine (<3 months);
- •History of recent rib fracture (<3 months);
- •History of recent herniated disc surgery (<3 months);
- •Patient with diagnosed fracture osteoporosis;
- •Patient with heart or circulatory disease or respiratory failure;
- •Patient presenting with a tumor or infectious process of the vertebrae;
- •Pregnant or likely to be (of childbearing age, without effective contraception) or breastfeeding;
- •Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- •Patient not beneficiary of a social security scheme.
研究组 & 干预措施
ATLAS
Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected.
干预措施: Visual analog scale (Other)
ATLAS
Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected.
干预措施: Mac Gill Pain Questionnaire (Other)
ATLAS
Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected.
干预措施: Roland and Morris Disability Questionnaire (Other)
ATLAS
Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected.
干预措施: Quebec questionnaire (Other)
Standard lumbar support belt
Standard lumbar support belt : LombaSkin® or Lombogib®
干预措施: Visual analog scale (Other)
Standard lumbar support belt
Standard lumbar support belt : LombaSkin® or Lombogib®
干预措施: Mac Gill Pain Questionnaire (Other)
Standard lumbar support belt
Standard lumbar support belt : LombaSkin® or Lombogib®
干预措施: Roland and Morris Disability Questionnaire (Other)
Standard lumbar support belt
Standard lumbar support belt : LombaSkin® or Lombogib®
干预措施: Quebec questionnaire (Other)
结局指标
主要结局
Evolution of the lumbar pain
时间窗: 1 hour after the start of the port
The primary outcome measure is the change in lumbar pain assessed by the patient using an VAS from 0 to 100 mm.
次要结局
- To assess the safety and tolerance of the devices(Between Day 0 and Day 8)
- Satisfaction of the patient(After a period of 8 days of wearing the medical device)