Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain: a Randomized Controlled Trial Nested in the "ComPaRe" E-cohort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Mean change in activity limitations
研究概览
简要总结
The investigators hypothesize that a personalized and automated digital coaching could reduce activity limitations in people with chronic low back pain as compared to usual care
详细描述
Non-specific low back pain (LBP) is the leading cause of years of life lived with disability worldwide and its burden is growing alongside the increasing and ageing population.
LBP is usually treated according to symptoms duration, presence of concomitant radicular pain and of consistent anatomical abnormalities and is defined according to symptoms duration: acute (< 6 weeks), subacute (6 to 12 weeks) and chronic (> 12 weeks). The prognosis of acute LBP is excellent, but in 5 to 15% of individuals, LBP becomes chronic. At 6 months, about 10% of individuals with chronic LBP are on sick leave, and at 12 months, 20% report persistent disability.
Unfavourable evolution of chronic LBP is characterized by onset and persistence of spine-specific disability in all individuals and work absenteeism in working age individuals. The probability of returning to work is only 20% after 1 year of sick leave and 0% after 2 years. Multidisciplinary rehabilitation that combines education, physical therapy, cognitive behavioural therapy and rehabilitation is usually offered. However, lack of personalization of these programs could affect their efficacy and systematic evaluation suggests their low cost-effectiveness).
Current management of non-specific chronic low back pain involves a multidisciplinary approach that typically includes non-opioid analgesics, physical exercise and strength training, education, and cognitive behavioural therapies. Therapeutic interventions such as massage, acupuncture, or spinal manipulation may also be beneficial.
The investigators hypothesize that a personalized and automated digital coaching could reduce activity limitations in people with chronic LBP, as compared to usual care.
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
- •Adults aged 18 or over
- •Having non-specific chronic LBP
- •Participating in the "ComPaRe" e-cohort
- •Having provided consent for their data to be used to assess trial eligibility
- •And to be randomized if eligible
- •And to, allow their data to be used to evaluate intervention effectiveness without being notified that they are in the control group, if randomized to usual the control group
- •Having a valid email address
- •Able to read and write French Having a smartphone functioning with Android acquired after 2020
排除标准
- •No exclusion criteria
研究组 & 干预措施
Experimental group
Personalized and automated digital coaching smartphone application
干预措施: Personalized and automated digital coaching using a mobile application (Device)
Comparator group
Usual care
结局指标
主要结局
Mean change in activity limitations
时间窗: 4 months
French version of the self-administered Roland Morris Disability Questionnaires (RMDQ). Higher scores indicate worse function
次要结局
- Work absenteeism at 12 months after consent(12 months)
- Work absenteeism at 4 months after consent(4 months)
- Mean change in the intensity of low back pain at 12 months after consent(12 months)
- Mean change in activity limitations at 12 months after consent(12 months)
- Mean change in the intensity of low back pain at 4 months after consent(4 months)
