Lumbar Belt Benefit Compared to the Usual Care in the Treatment of Non-specific Low Back Pain -an Interventional, Prospective, Multicenter, Randomized, Open and Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Thuasne
- 入组人数
- 168
- 试验地点
- 4
- 主要终点
- Change from baseline ODI score (Oswestry Disability Index) at 12 weeks
研究概览
简要总结
Lumbar belt benefit compared to the usual care in the treatment of non-specific low back pain -an interventional, prospective, multicenter, randomized, open and controlled.study
详细描述
This is a controlled study, with randomization of the patients, which aims at evaluating the benefit and interest of wearing a new generation lumbar belt, in patients suffering from non-specific low back pain. This trial is also designed to provide quality of life data and to assess the medico-economic interest of wearing such a lumbar belt.
This is an interventional study with low risks and constraints that does not deviate from the local standard of care for enrolled patients. No invasive examination or procedure is performed; as such, there will be no additional risks for participating patients.
203 patients will be followed during 12 weeks in up to 20 investigational sites Patients meeting all eligibility criteria will be included in the study and randomized into one of the two following groups on a 1: 1 ratio.
- Control group "usual care": promotion of physical activity and taking usual medicines for pain relief
- Intervention group: wearing the LombaStab belt in addition to usual care (promotion of physical activity and taking usual medicines for pain relief).
Three visits will be performed:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged from 18 to 55 years old
- •Patient suffering from non-specific low back pain with current episode has progressed for 1 to 6 months
- •At least one lumbar mean pain at rest or at effort of the last 72 hours collected on inclusion ≥ 40/100 on an NRS scale.
- •Ability of the patient or legally authorized representative to provide a signed and dated i informed consent form before any procedure or data collection.
- •Patient covered by the French Social security system.
排除标准
- •Patient wearing a lumbar belt the day of the inclusion visit
- •Patient who has had surgical intervention on dorso-lumbar spine or lower limb the past 5 years or who has planned surgery during the study
- •MODIC diagnosis (disc degeneration) known or confirmed by MRI
- •On sick leave for more than 3 consecutive months due to low back pain at the time of inclusion
- •Low back pain related to an accident at work
- •Low back pain due to secondary origin: tumor, inflammatory, infectious cause, related to a fracture or a vertebral compression
- •Patient with fibromyalgia
- •Patient with lumbar radicular syndrome (radicular conflict like disc herniation, spinal stenosis...)
- •Pregnant woman or trying to become pregnant during the study
- •Patient with confirmed depression
- •Patient with cognitive or mental disorders
- •Morphology with measurements not allowing to match with the sizes of belts available
- •Patient presenting chronic pathology with disabling functional consequences
- •Patient who received an infiltration less than one month before inclusion visit or planned during the study
- •Patient with known allergy to any of the materials (see product composition in the Description section of user instruction)
- •Patient with contraindicated to belt wearing: hiatus hernia, deficient respiratory functions
- •Anticipated poor compliance of subject with study procedures
- •Current participation in an interventional investigation drug or device treatment study with an impact on evaluation criteria
结局指标
主要结局
Change from baseline ODI score (Oswestry Disability Index) at 12 weeks
时间窗: Week: 0 and 12
The functional capacity is measured by ODI score.The ODI questionnaire consists in 10 questions and 6 answers modalities.The ODI score results are expressed in percentage.The higher the percentage is, the more the functional capacity is impaired.
次要结局
- Evolution of functional capacity(Week: 0 and 4)
- Evolution of pain level(Week: 0, 4 and 12)
- Evolution of pain characteristics(Week: 0, 4 and 12)
- Evolution of Quality of Life(Week: 0 and 12)
- Evolution of spinal mobility vie Finger to floor distance test(Week: 0, 4 and 12)
- Duration of Sick leave(Week: 0, 4 and 12)
- Assessment of doctors' opinion on improving the patient's health condition caused by low back pain and severity(Week 0, 4 and 12)
- Assessment of patient's opinion on Global Impression of Change about his general condition(Week: 4 and 12)
- Evolution of spinal mobility via Schober Mac Rae test(Week: 0, 4 and 12)
- Evolution of physical activity(Week: 0, 4 and 12)
- Evolution of drug consumption(Week: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
- Assessment of patient's satisfaction about the lumbar belt comfort and design(Week 12)
- Assessment of tolerance(Week: 4 and 12)
- Assessment of time of belt's wearing(through study completion, an average of 12 weeks)
- Medical and paramedical consultations(Week: 0, 4 and 12)