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
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
- 否
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.)
