跳至主要内容
临床试验/NCT05390762
NCT05390762已完成不适用

Evaluation of the Functional Efficacy of a Multidisciplinary Telecare Rehabilitation Program in Chronic Low Back Pain with Psychological Retention and Predominant Sociability : Single Center Randomized Controlled, Single-blind Trial

Pôle Saint Hélier2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
Oswestry Disability Index

研究概览

简要总结

The present study proposes to evaluate the impact of a multidisciplinary biopsychosocial Telecare rehabilitation program at the functional level in people with chronic low back pain with major psycho-behavior maintenance. The hypothesis is that a personalized program combining remote psycho-professional and physical care by digital tools improves functional evaluation in these patients.

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)

盲法说明

The evaluations will be performed by blind operators of the program.

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

  • Chronic low back pain (evolution of more than 3 months)
  • Patient treated for this pathology in a multidisciplinary program
  • Dallas score > 50% in anxiety/depression and sociability dimensions
  • Patient who has given free and informed consent to participate in the research
  • Patient affiliated to a social security scheme or beneficiary of such a scheme.
  • Patient with an internet connection at home, allowing videoconferencing and a digital tool with web cam (tablet or computer).

排除标准

  • Recent spine surgery (< 3 months at inclusion visit)
  • Cardiovascular risk factor contraindicating sports practice.
  • Severe psychiatric pathology
  • Low back pain of tumoral or inflammatory origin.
  • Associated motor or sensory, neurological impairment.
  • Disabling root irradiation
  • Pregnant or breastfeeding women
  • Patients under legal protection (guardianship, curators or safeguard of justice).

结局指标

主要结局

Oswestry Disability Index

时间窗: 3 months after the end of rehabilitation

Overall score of the Oswestry self-questionnaire. The score goes from 0 to 50, It will be converted into a percentage (Score ODI). Zero is equated with no disability and 100 is the maximum disability possible.

次要结局

  • Sub pelvis muscle flexibility.(At the end of the rehabilitation and 3 month after.)
  • Spontaneous pain(At the end of the rehabilitation and 3 month after.)
  • Endurance of trunk extensors(At the end of the rehabilitation and 3 month after.)
  • Endurance of trunk flexors(At the end of the rehabilitation and 3 month after.)
  • Range of motion of lumbar mobility(At the end of the rehabilitation and 3 month after.)
  • Overall flexibility(At the end of the rehabilitation and 3 month after.)
  • Economic efficiency(At the end of the rehabilitation)
  • Compliance(At the end of the rehabilitation)
  • Quadriceps strength(At the end of the rehabilitation and 3 month after.)
  • Anxiety and depression(At the end of the rehabilitation and 3 month after.)
  • Socio professional criteria(3 months after the end of rehabilitation)
  • The kinesiophobia(At the end of the rehabilitation and 3 month after.)
  • Functional abilities(At the end of the rehabilitation and 3 month after.)
  • Acceptability(At the end of the rehabilitation program and 3 months after.)

研究者

发起方
Pôle Saint Hélier
申办方类型
Other
责任方
Sponsor

研究点 (2)

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