Medico-economic Impact of Functional Restoration for Chronic Low Back Pain: a Multicenter, Prospective, Controlled, Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Incremental cost per quality-adjusted life year (QALY)
研究概览
简要总结
The hypothesis is that functional restoration is not only effective in term of activity limitation, but also efficient, in regard to its impact on this criterion, the use of healthcare services, return to work and job retention, in the context of chronic low back pain with occupational disability.
The main objective is the medico-economic evaluation of a functional restoration program for chronic low back pain, in order to determine its efficiency using a differential cost-utility approach from an insurance perspective at 24 months after inclusion.
详细描述
Scientific justification Low back pain is a major public health problem. It is the leading cause of functional limitation in adults and one of the primary areas of expenditure for national health systems. Indirect costs account for the majority of related expenses.
Chronic low back pain accounts for 80% of compensation for occupational disability due to low back pain. It generates most of the costs attributable to all common low back pain.
Mainland and Caribbean France are no exception to this reality. A national study conducted by the French health insurance system in 2014 shows that low back pain accounts for 30% of work stoppages lasting more than six months and 20% of all workplace accidents. A survey conducted under the auspices of the Martinique Regional Health Agency in five hospitals indicates that 75% of healthcare workers had experienced an episode of low back pain in the previous three years, and that half had taken time off work for this reason. The prevalence of chronic low back pain in this population of workers was 25%.
Therapeutic recommendations converge on the benefits of coordinated multidisciplinary physical medicine and rehabilitation programs for chronic low back pain. Functional restoration is a coordinated multidisciplinary approach to the management of chronic low back pain. Its effect on functional limitation in chronic low back pain has now been demonstrated, but the efficiency of this treatment remains to be characterized. Thus, the efficiency of functional restoration for chronic low back pain has not yet been evaluated. Functional restoration reduces functional limitation in the short term and at one year. In France, a randomized trial indicates the possibility of a reduction in occupational disability. Investigators experience based on a prospective analysis also supports this.
The efficiency of functional restoration for chronic low back pain has not been evaluated. The management of chronic low back pain in the French West Indies has been little studied.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low back pain for at least 3 months
- •Low back pain with an intensity greater than or equal to 40/100 on a visual analog scale
- •Low back pain with a mechanical pattern (reduced by rest)
- •Low back pain on mobilization or palpation of the lumbar spine
- •Standard X-ray or MRI of the lumbar spine taken at the same time as the low back pain, showing normal or degenerative (arthritic) changes in the lumbar spine
- •Patient on sick leave due to low back pain for at least 3 months and less than 2 years
- •Patient who speaks and writes French
- •Patient with social security coverage
排除标准
- •Low back pain of inflammatory, infectious, tumorous, or fracture origin
- •Radiculalgia in a lower limb greater than 40/100
- •Radiculalgia in a lower limb with neurological complications (motor function less than or equal to 3/5 or cauda equina syndrome)
- •Cortisone injection into the lumbar spine in the previous month
- •Lumbar spine surgery in the previous 6 months
- •Heart or respiratory failure
- •Psychiatric condition preventing assessment of low back pain
- •Pregnancy
- •Refusal to participate in the study
- •Individuals benefiting from judicial protection measures
研究组 & 干预措施
functional restoration
干预措施: functional restoration (Procedure)
non-intensive rehabilitation
干预措施: non-intensive rehabilitation (Procedure)
结局指标
主要结局
Incremental cost per quality-adjusted life year (QALY)
时间窗: At 24 months after randomization
Incremental cost per quality-adjusted life year (QALY) at 24 months after inclusion, established using the EuroQol 5 Dimensions (EQ-5D) questionnaire and resource utilization costs. Resource utilization costs correspond to healthcare costs and compensation for occupational disability.
次要结局
- Cost of resource use(at 12 months and 24 months)
- Incremental cost per quality-adjusted life year (QALY)(at 12 months)
- Overall pain(at 4 months, 12 months, and 24 months)
- Activity limitation assessed(at 4 months, 12 months, and 24 months)
- Inappropriate fears and beliefs(at 4 months, 12 months, and 24 months)
- Coping strategies(at 4 months, 12 months, and 24 months)
- Anxiety and depression(at 4 months, 12 months, and 24 months)
- Number of days per week that self-rehabilitation was followed(at 4 months, 12 months, and 24 months)
- Physical activity(at 4 months, 12 months, and 24 months)
- Quality of life(at 4 months, 8 months, 12 months, 16 months, 20 months, and 24 months)
- Use of healthcare services(at 4 months, 8 months, 12 months, 16 months, 20 months, and 24 months)