跳至主要内容
临床试验/NCT04128098
NCT04128098终止不适用

Frequency of Correct Response and Factors Associated in the Medium Term With a Multimodal Rehabilitation Program for Chronic Low Back Pain

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2020年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
Proportion of good medium-term responders in a multimodal rehabilitation program

研究概览

简要总结

Non-specific chronic low back pain is defined as pain that originates in the lumbar spine, is persistent, lasts more than 3 months, and is unrelated to an inflammatory, traumatic, tumour, malformation, or infectious cause. Chronic low back pain is one of the most frequent reasons for consulting a physician, and one of the most common sources of disability, particularly as a result of socio-professional withdrawl. It is a major consumer of health resources (diagnostic investigations, multiple treatments) and involves heavy expenses for the investigator's health insurance system. In view of this major public health issue, in November 2017, the Health Insurance and several specialized health organizations launched a "general public" campaign to raise awareness of low back pain. This campaign, entitled "Back pain? The right treatment is movement" was designed to encourage appropriate physical activity in patients with low back pain.

Among the available therapies, multimodal programs are recommended as a first line treatment. In order to incorporate physical activity into patients' daily lives, these rehabilitation programs are based on a comprehensive multidisciplinary approach (therapeutic education, muscle strengthening, reconditioning, ergonomics, psychological, social, professional and nutritional management and cardiovascular risk factors). Although such programmes have already shown short term effectiveness, few data are available on their continued effectiveness in the medium term (1 year). This project aims to identify good and bad responders to a multimodal program in the medium term, based on common clinical parameters (Quebec City questionnaire score and spontaneous walking speed), and to identify the mechanisms underlying this response.

In addition, in clinical practice, heterogeneity in maintaining the effectiveness of the program is observed but little documented. The limited data available show a heterogeneity of these programs and one of the objectives of this project will be to identify the existing barriers and levers available to improve this situation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Adult patient
  • Having provided oral consent
  • Chronic non-specific low back pain (HAS2015 criteria)
  • Eligible for a rehabilitation program
  • Patient affiliated or benefiting from a social security scheme

排除标准

  • Adult unable to provide consent
  • Lumbar spine surgery scheduled in the coming year
  • Associated pathologies other than spinal (orthopedic, neurological, vascular, cardiac...) that can affect locomotion
  • Root damage with motor deficit <3
  • Altered comprehension skills making self-assessment impossible
  • Patient subject to a protective measure (guardianship, curatorship)
  • Patient subject to a judicial protection
  • Pregnant, parturient or breastfeeding woman
  • Not fluent in French
  • Patient who has already completed a multimodal rehabilitation program

结局指标

主要结局

Proportion of good medium-term responders in a multimodal rehabilitation program

时间窗: M13 (12 months after the end of the program)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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