Cross Over Pilot Study for Evaluation of Pain Reduction in Patients With Chronic Low Back Pain (for More Than 3 Month) Using an Innovative Handheld Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pain release with the ATLAS device during standardized daily activities
研究概览
简要总结
The aim of the study is to evaluate the reduction of pain by wearing the ATLAS Medical Device in standardized daily activities for patients with Chronic Low Back Pain.
This is an intervention al non blinded study with a crossover design comparing pain evaluated with an Analogue Visual Scale with and without the ATLAS device during 5 standardized daily activities.
详细描述
This study aims at assessing pain release by wearing a new medical device (ATLAS) in patients affected by chronic low back pain.
Population: patients with chronic low back pain admitted for a 4 weeks rehabilitation program.
Intervention: active rehabilitation and wearing the ATLAS device 60 min per day. The ATLAS study is carried out during the 5 first days of the rehabilitation program.
Primary outcome: Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) during 5 standardized activities (the most intensive pain during the 5 activities is recorded), with and without wearing the ATLAS device.
Secondary outcome measures: percentage of patients reporting pain decrease of at least 20 mm on the 100 mm VAS during the 5 standardized activities with the ATLAs device compared without wearing the device. Percentage of relieved patients (percentage of patient reporting pain intensity less than 30 mm on the 100 mm VAS with wearing the device). Pain intensity evaluated with the 100 mm VAS before and after 60 min of wearing the ATLAS device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •Chronic low back pain for more than 3 month
- •Analogical visual scale superior or egal to 3/10
- •BMI < 30
- •18 < Age < 75 years
- •Patients who signed the informed consent
- •Hospital Anxiety and depression score less than 11
排除标准
- •- Neurological or radicular deficit
- •Skin pathology of the trunk region
- •Antecedent of surgery of spinal fusion
- •Implanted neurostimulation treatment
- •Scoliosis with Cobb angle > 30°
- •History of vertebral fracture
- •BMI > 30
- •Respiratory failure
- •Recent rib fracture (less than 3 month)
- •Pregnancy or breastfeeding
- •Osteoporosis
- •Refusal to participate to the study
结局指标
主要结局
Pain release with the ATLAS device during standardized daily activities
时间窗: at 5th day of a 4 weeks rehabilitation program.
Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) from 0 to 100 mm (0 means no pain and 100 means extremely severe pain) during the standardized daily activities (the most intense pain reported during the 5 activities is recorded).
次要结局
- Percentage of patients relieved with the ATLAS device(at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.)
- Pain release with the ATLAS device during standardized daily activities(at day the 1st , 4th day of a 4 weeks rehabilitation program.)
- Percentage of improved patients(at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.)