Evaluation of the Japet.W+ Medical Device for Low Back Pain Management: Performance and Safety Analysis Across Two Patients' Groups
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
The JAPET.W+ medical device is a new dynamic distraction support system. It could be considered as a new solution in the therapeutic arsenal for managing common low back pain. This study aims to assess the effectiveness of this device among the two targeted populations during daily use. Each patient will be asked to estimate the intensity of their low back pain several times during the clinical investigation. Our main hypothesis is a reduction in low back pain while wearing the device. The secondary hypothesis is a decrease in activity limitations, an increase in participation, an improvement in quality of life, and a reduction in healthcare product and medication consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-specific chronic low back pain with active discopathy OR Non-specific chronic low back pain without active discopathy,
- •18 years ≤ Age < 80 years,
- •Average pain intensity (VAS) over the last week ≥ 40/100,
- •Patient affiliated to the health social security system,
- •Patient able to understand the information relating to the study and to sign the informed consent form.
排除标准
- •Specific low back pain (infectious, inflammatory, tumorous, or traumatic in origin).
- •Motor neurological deficits (peripheral or central).
- •Extrapyramidal syndrome.
- •Treatment with implanted neurostimulation.
- •Severe heart or circulatory disease or respiratory problems.
- •Arthrodesis or disc replacement.
- •Surgery for herniated disc (<3 months).
- •Spinal fracture or floating ribs (<3 months).
- •Skin lesions on the trunk, history of contusions or skin lesions following traction of the trunk.
- •Pregnancy.
- •Patients who cannot tolerate the JAPET.W+ device during an initial trial.
- •Patients under guardianship, curatorship, or legal protection.
- •Participation in another clinical trial.
- •Patients who have worn a device designed to reduce lower back pain regularly during the 2 weeks prior to inclusion (lumbar belt, corset, exoskeleton).
研究组 & 干预措施
Group B
Period 1 (week 1-8): Current care + Japet.W+ / Washout period (week 9-10) / Period 2 (week 11-18): Current care
干预措施: Japet.W+ (Device)
Group A
Period 1 (week 1-8): Current care / Washout period (week 9-10) / Period 2 (week 11-18): Current care + Japet.W+
干预措施: Japet.W+ (Device)
Group A
Period 1 (week 1-8): Current care / Washout period (week 9-10) / Period 2 (week 11-18): Current care + Japet.W+
干预措施: Control (Standard treatment) (Device)
Group B
Period 1 (week 1-8): Current care + Japet.W+ / Washout period (week 9-10) / Period 2 (week 11-18): Current care
干预措施: Control (Standard treatment) (Device)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Comparison of the difference Δ1=VASweek8 - VASweek1 and Δ2=VASweek18-VASweek11.
Pain VAS is a unidimensional measure of pain intensity (from 0: no pain to 100: severe pain), used to record the progression of pain in patients or to compare the severity of pain between patients with similar conditions. The VAS has been widely used in various adult populations, for example people suffering from chronic low back pain.
次要结局
- Adverse events(Week 4 day 7, Week 8 day 7, Week 14 day 7 and Week 18 day 7)
- Rate of device failure(Group B: Week 4 day 7, Week 8 day 7 / Group A: Week 14 day 7 and Week 18 day 7)
- Functional disability(Beginning and end of each period (Week 1 day 1, Week 8 day 7, Week 11 day 1, Week 18 day 7).)
- Quality of life(Beginning and end of each period (Week 1 day 1, Week 8 day 7, Week 11 day 1, Week 18 day 7).)
- Adherence to Japet.W+(Recovery of Japet.W+ usage time after 28 days and 56 days of use. Group A (using the device during the second period): Week 14, day 7, and Week 18, day 7. Group B (using the device during the first period): Week 4, day 7, and Week 8, day 7.)
- Number of healthcare products consumed (drugs, medical appointments, physiotherapy sessions, etc.)(Information retrieved 3 times per period (D+7, D+28, D+56). Period 1: Week 1 day 7, Week 4 day 7, Week 8 day 7. Period 2: Week 11 day 7, Week 14 day 7, and Week 18 day 7.)