跳至主要内容
临床试验/NCT06498271
NCT06498271尚未招募不适用

Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain: a Randomized Controlled Trial Nested in the "ComPaRe" E-cohort

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

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

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

Experimental

Personalized and automated digital coaching smartphone application

干预措施: Personalized and automated digital coaching using a mobile application (Device)

Comparator group

No Intervention

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验