Evaluation of the Effectiveness of a MOTIVational Support Program After Multidisciplinary Functional Rehabilitation in Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Difference in disability and pain between the experimental (SHP) and control (usual care) groups, measured with the Core Outcome Measure Index (COMI) scale at 12 months.
研究概览
简要总结
Chronic low back pain (CLBP) is a major public health problem. Multidisciplinary functional rehabilitation program (FRP), which give patients the skills to better manage pain and return to physical activity, are effective in the short term. In the medium and long term, due to lack of motivation, two thirds of patients stop their physical activity again, causing them to fall back into the vicious circle of pain. Investigators hypothesise that a remote assessment and motivational support program (MSP) based on an application, piloted by a care coordinator, could allow the continued improvement of symptoms and activities observed after the FRP programs, and thus limit the consequences of CLBP for the patient and society. The main objective of this study is to evaluate the effect of the motivational support program EMOTIV, on disability and pain at one year, in chronic low back pain patients who have benefited from a FRP program.
详细描述
Multidisciplinary functional rehabilitation program (FRP) have shown their efficacy in disabilitie patient suffering from Chronic low back pain (CLBP). Unfortunately, at medium and long term two thirds of patients stop their physical activity due to lack of motivation. These patients then fall back into their painful vicious circle. Investigators hypothesis that motivational support program (MSP) based on an application, piloted by a care coordinator could increase the motivation to continue physical activity and thus limit the consequences of CLBP for the patient and society. The main objective is to evaluate the impact of a MSP (EMOTIV) on pain and functional abilities assessed according to the COMI scale (Core Outcome Measure Index), 12 months after a FRP in patients with LPBC. This program is compared to usual care as currently done. The secondary criteria concern: physical, neuropsychological and medico-economical criteria. This is a multicentre, cluster randomized trial. All adult patient suffering from low back pain, having finished a FRP and possessing a smartphone, will be included. Investigators plan to include 150 patients in 6 centres. The duration of the inclusion period is 12 months; The duration of participation of each subject is 24 months. Inclusion will be on the last day of the FRP program. The Follow-up in consultation is scheduled at 3, 12 and 24 months with evaluation of usual criteria (physical, self-questionnaires, and advice on the practice of physical activities depending on what is achieved). In Pitie salpetriere center only, patients will have in addition: lumbar MRI at 3 and 12 months; central pain awareness assessment. The activity of patients in the MSP group will be recorded continuously par EMOTIV App; pain, mental health and days off every week and self-questionnaires at 1, 2 and 6 months. The primary analysis of all endpoints will be performed in the intent-to-treat population, i.e. all patients randomized to the study. The COMI score will be compared between the 2 randomized groups by a linear mixed model.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or over
- •Disabling chronic low back pain: chronic painful patient, that is to say suffering from pain for more than 3 months, having interrupted all physical activity because of low back pain and have an indication for a FRP for low back pain.
- •Having reached the end of an FRP program
- •Possession of a smartphone
- •Fluency in French (writing, reading)
- •Health insurance coverage (beneficiary or beneficiary) except State Medical Aid.
- •Patient Informed Consent Signature
排除标准
- •Pregnant woman
- •Patient refusal
- •Patient deprived of liberty and patient under legal protection measure (guardianship, guardianship)
- •Patient participating to another interventional search
结局指标
主要结局
Difference in disability and pain between the experimental (SHP) and control (usual care) groups, measured with the Core Outcome Measure Index (COMI) scale at 12 months.
时间窗: 12 months after completion of the multidisciplinary functional rehabilitation program
The Core Outcome Measure Index (COMI) was developed from requirements of international back pain experts. According to European experts, the COMI should currently be recommended in assessment of chronic low back pain. This questionnaire assesses pain and disability in low back pain. It includes 9 items and its score is between 0 and 10. Higher scores is the worse outcome.
次要结局
- Evolution of the level of anxiety and depression(At 3 months, 12 months and 24 months)
- Evolution of the level of central pain awareness(At inclusion, 3 months, 12 months and 24 months)
- Productivity loss (i.e, sick leave-related costs or indirect costs)(At 3 months, 12 months and 24 months)
- Satisfaction with the program(At 3 months, 12 months and 24 months)
- Evolution of flexibility(At 3 months, 12 months and 24 months)
- Evolution of endurance and sports performance (VO2 max)(At 3 months, 12 months and 24 months)
- Sick leave days(At 3 months, 12 months and 24 months)
- Evolution of pain(At 3 months, 12 months and 24 months)
- Evolution of disability and pain(At 3 months, 12 months and 24 months)
- Evolution of the intensity of physical activity(At 3 months, 12 months and 24 months)
- Evolution of muscular trophicity in the 2 groups(At 3 months and 12 months)
- Medico-economic analysis(At 3 months, 12 months and 24 months)
- Cost of care (i.e, health resource use and related costs or direct costs)(At 3 months, 12 months and 24 months)
- Adherence to the program(At 3 months, 12 months and 24 months)
- Evolution of muscular endurance(At 3 months, 12 months and 24 months)