Impact of a Multidisciplinary Rehabilitation Program and Doado Application on the Functional Disability of Patients With Low Back Pain at Risk of Chronicization, Compared With a Monodisciplinary Rehabilitation Program and Doado Application.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Functional disability
研究概览
简要总结
This study is aimed at patients consulting a physiotherapist for acute low-back pain at risk of becoming chronic.
The goal of this study is to compare two types of rehabilitation programs for these patients, on their functional disability at 3 months:
- A multidisciplinary program lasting two weeks, including physiotherapists, rheumatologists, physical medicine and rehabilitation specialists, occupational physicians, psychologists, etc.
- A monodisciplinary physiotherapy rehabilitation program consisting of active treatment with a physiotherapist, with 2 to 3 sessions per week for 4 to 5 weeks, based on muscle-strengthening exercises for the trunk and lower limbs and stretching exercises for the back and lower limbs.
Patients will be evaluated before treatment (baseline), and at 1, 3, 6 and 12 months to evaluate the following secondary outcomes: pain, absence of chronicity, evolution of functional disability, muscle endurance, flexibility, level of fear, apprehension and avoidance associated with low back pain over the time, return to work and to physical activities, painful relapses and analgesic treatment consumption.
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
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suffering from acute common low back pain for less than 3 months at the time of the initial consultation
- •With a prescription for physiotherapy
- •Available for both programs
- •Aged between 20 and 55
- •Equipped with a smartphone compatible with the Doado application
- •Having been informed and having signed the free and informed consent form prior to any specific study procedure
- •Affiliated to a health insurance scheme
排除标准
- •suffering from a first episode of acute common low back pain for less than one month at the time of the initial consultation
- •With a history of spinal surgery:
- •For lumbar arthrodesis in the 12 months prior to inclusion
- •For lumbar arthroplasty in the 6 months prior to inclusion
- •For lumbar recalibration or lumbar disc herniation within 3 months of inclusion.
- •With suspected specific low-back pain
- •Suffering from radiculalgia of the lower limbs
- •Suffering from sensory-motor disorders of the lower limbs
- •Suffering from continuous low-back pain for at least 3 months
- •Have severely impaired physical and/or psychological health, which in the investigator's opinion may affect the participant's compliance with the study.
- •Participating in other interventional research
- •In a period of exclusion from other research still in progress at the time of inclusion.
- •Protected: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
- •Pregnant, breast-feeding or parturient.
研究组 & 干预措施
Multidisciplinary management associated with mobile application Doado
10 half-day sessions, in a day hospital, for 2 weeks, 5 times a week (Monday to Friday), each comprising 3 workshops, with the following contributors: physiotherapist, doctor, nurse, occupational therapist, psychologist, dietician, Adapted Physical Activity (APA) teacher. This program is associated with the Doado mobile application.
The Doado mobile application includes rehabilitation exercises and educational content, to be used at home by the patients.
干预措施: Multidisciplinary management associated with mobile application Doado (Other)
Physiotherapy management alone associated with mobile application Doado
10 active functional re-education sessions (1 hour), 2 to 3 per week (sessions are therefore spread over approximately 4 to 5 weeks), based on muscle-strengthening exercises for the trunk and lower limbs, as well as stretching exercises for the back and lower limbs. This program is associated with the Doado mobile application.
干预措施: Physiotherapy management alone associated with mobile application Doado (Other)
结局指标
主要结局
Functional disability
时间窗: baseline, 3 months
Oswestry disability Index (ODI): 10 questions with 6 possible answers each, to assess the impact of the pain on several life habits and functionalities (walk, personal care, sitting position, etc.). The score is expressed as a percentage of handicap between 0 and 100%.
次要结局
- Lumbar pain(baseline, one month, 3 months, 6 months, 12 months)
- Fear, apprehension and avoidance related to low back pain (SBST questionnaire)(baseline, one month, 3 months, 6 months, 12 months)
- Lumbar pain chronicity(over 12 months of follow-up)
- Painful relapses(between baseline and 1 year of follow-up)
- Functional disability(Baseline, one month, 3 months, 6 months, 12 months)
- Muscular endurance (Shirado-Ito test)(baseline, one month, 3 months)
- Muscular endurance (hip bridge endurance)(baseline, one month, 3 months)
- Muscular endurance (Biering-Sorensen)(baseline, one month, 3 months)
- Muscular endurance (Killy test)(baseline, one month, 3 months)
- Flexibility (finger-ground distance test)(baseline, one month, 3 months)
- Flexibility (knee extension angle test)(expressed in degrees of amplitude Time Frame : baseline, one month, 3 months)
- Flexibility (hill-ischin procubitus measurement test)(baseline, one month, 3 months)
- Return to sport activities(between baseline and 1 year of follow-up)
- Fear, apprehension and avoidance related to low back pain (FABQ questionnaire)(baseline, one month, 3 months, 6 months, 12 months)
- Return to work(between the end of the 2 weeks of initial treatment and 1 year of follow-up)
- Analgesics consumption(over 12 months of follow-up)
- Patient satisfaction regarding each program(one month of follow-up)