Assessing the Japet.W+ Lumbar Traction Device in Rehabilitation for Patients With Non-specific Mechanical Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of the efficacy of the JAPET.W - Assessment of the kinesiophobia
研究概览
简要总结
The study will include patients suffering from nonspecific mechanical low back pain for more than 6 weeks. Two groups will be compared. A Control group and an Experimental group with the exoskeleton JAPET.W
详细描述
The study will include patients suffering from nonspecific mechanical low back pain for more than 6 weeks. The study will consist of two groups: a control group (Group CTRL) and an experimental group (Group EXP). Participants will be categorized into two categories: "workers," patients on temporary work leave due to low back pain, and "non-workers," patients unable to work due to this condition after exhausting all available therapeutic solutions.
Monitoring period (30 physiotherapy sessions): evaluations will be conducted at sessions 1, 15 and 30, on the two groups. Evaluation session 3 months after the end of the physiotherapy sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nonspecific mechanical low back pain for more than 6 weeks,
- •18 years ≤ Age < 80 years,
- •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 origin),
- •Motor neurological deficits (peripheral or central),
- •Extrapyramidal syndrome,
- •Treatment with implanted neurostimulation,
- •Cardiac or circulatory diseases or serious respiratory problems,
- •Previous recent arthrodesis or recent lumbar prosthesis surgery,
- •Surgery for herniated disc (<3 months),
- •Fracture of the dorsolumbar spine or rib (<3 months),
- •Skin lesions, contusions and stretching injuries of the trunk,
- •Pregnancy,
- •Individuals not tolerating the JAPET.W+ device during an initial trial,
- •Under guardianship, curatorship or legal protection
研究组 & 干预措施
Group CTRL
Participants will undergo 30 sessions of conventional physiotherapy
Group EXP
Participants will undergo 30 sessions of physiotherapy with the use of the Japet.W+ Exoskeleton
干预措施: Use of the Exoskeleton JAPET.W (Other)
结局指标
主要结局
Assessment of the efficacy of the JAPET.W - Assessment of the kinesiophobia
时间窗: Up to six months
Comparison of the difference in TAMPA scale. This scale goes to 1-strongly disagree to 4-strongly agree with the proposal
Assessment of the efficacy of the JAPET.W - Assessment in quality of life
时间窗: Up to six months
Assessment in quality of life with EQ-5D-5L. The scale goes to 1-totally able to carry out the activity up to 5-totally unable to do so.
Assessment of the efficacy of the JAPET.W - Assessment of the Anxiety level
时间窗: Up to six months
Assessment of the Anxiety level with Hospital Anxiety Depression Scale. This scale ranges from 0-no anxiety to 3-totally anxious.
Assessment of the efficacy of the JAPET.W - measurement of pain
时间窗: Up to six months
VAS scale for pain (o -no pain to 10 - pain as bad as it could possibly be) : rate of the patients who had at least -20 points/100 on the VAS for pain
Assessment of the efficacy of the JAPET.W - consumption of analgesic
时间窗: Up to six months
Assessment of analgesic use in the two groups at the first and last session
Assessment of the efficacy of the JAPET.W - functional assessment
时间窗: Up to six months
Mobility assessment with the french version of Oswestry Disablility Index. The scale goes from 0 - no pain to 5 - worse.
次要结局
- Assessment of the safety of the JAPET.W(Up to six months)