NCT04826757进行中（未招募）不适用
Effectiveness of Coordinated Care to Reduce the Risk of Prolonged Disability Among Patients Suffer From Subacute or Recurrent Acute Low Back Pain in Primary Care
University Hospital, Angers57 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2022年9月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
- 试验地点
- 57
- 主要终点
- Perceived inability at 1 year
研究概览
简要总结
Common low back pain affects about 23% of general population and can be associated with psychosocial difficulties and prolonged inability to work. Its management in France mainly depends on general practioners, and sometime on physiotherapists.
A coordinated care between general practioners, physiotherapists and occupational health services would help to improve the care pathway for patients and health professionals.
The main objective is to assess the impact of coordinated primary care and deployed at the territories' level, in subacute or acute recurrent low back pain patients in comparison with the standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient consulting an investigator GP for subacute low back pain or acute recurrent low back pain
- •Patient with occupational activity (including sick leave)
- •Patient depending of occupational health service
- •Obtaining the signature of the consent to participate in this trial
- •Patient Registered with social security scheme
- •Non-inclusion Criteria:
- •Specific low back pain (fracture, infection, osteoporosis, inflammatory disease, tumor)
- •Low back pain with sciatic, cruralgia
- •Contraindication to active reeducation
- •Impossibility to follow up during 12 months
- •Patient planning to retire within the 12 months following the enrollment
- •Disability to write or read french
- •Adult patient protected under the law (guardianship),
- •Pregnant, breastfeeding or parturient women
- •Persons deprived of their liberty by judicial or administrative decision
- •Persons subject to legal protection measures
- •Persons unable to consent
- •Persons on coercion psychiatric care
- •Physiotherapy by a physiotherapist who don't participate in this trial
排除标准
- 未提供
研究组 & 干预措施
standard care
No Intervention
standard care for low back pain management by general practioners (GPs). the physiotherapist and occupational health services can be solicited independently by the patient or GP.
coordinated care
Experimental
Coordinated care between general practioners, physiotherapist and occupational health services.
An intervention training will be performed before the start of the study for any care professional's to elaborate coordination tools and have an active communication.
干预措施: Coordinated care (Other)
结局指标
主要结局
Perceived inability at 1 year
时间窗: Enrollment to 12 months follow up
Ratio of patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire. The minimum value of Roland Morris Disability Questionnaire is 0 and the maximun value is 24. A higher score mean worse outcome
次要结局
- Occupational status(at 3 months, 6 months and 12 months)
- Roland Morris Disability score over time(Enrollment, 3 months, 6 months, 12 months)
- Improved patients(at 3 months, 6 months and 12 months)
- Numerical pain scale over time(Enrollment, 3 months, 6 months, 12 months)
- Depression component score of Hospital Anxiety and Depression Scale(Enrollment, 3 months, 12 months)
- Physiotherapist satisfaction related to patient care(T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion))
- Professionals trained for intervention(Baseline intervention formations)
- Number of consultations or sessions(during the 12 months of follow up)
- Sick leave(during 12 months after inclusion)
- Biopsychosocial component score of Pain Attitudes and Beliefs score - for intervention physiotherapists(T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion))
- Biopsychosocial component score of Pain Attitudes and Beliefs score - for GPs(T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion))
- Biomechanical component score of Pain Attitudes and Beliefs score - for GPs(T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion))
- Professional dialogues(during the 12 months of follow up)
- Perceived inability(Enrollment to 3 months follow up, Enrollment to 6 months follow up)
- Occupational component score of Fear Avoidance Beliefs Questionnaire(Enrollment, 3 months, 12 months)
- GP satisfaction related to patient care(T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion))
- Biomechanical component score of Pain Attitudes and Beliefs score - for intervention physiotherapists(T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion))
- Pain perceived(Enrollment - 3 months , Enrollment - 6 months and Enrollment -12 months)
- Employment rate(Enrollment, 3 months, 6 months, 12 months)
- Evolution of improved patients ratio(Enrollment, 3 months, 6 months, 12 months)
- Physical activity component score of Fear Avoidance Beliefs Questionnaire(Enrollment, 3 months, 12 months)
- Anxiety component score of Hospital Anxiety and Depression Scale(Enrollment 3 months, 12 months)
- Coordination care score of Patient Centered Coordination by a Care Team questionnaire(Enrollment, 3 months, 12 months)
- Mental component score of Short Form -12(Enrollment, 3 months, 6 months, 12 months)
- Physical component score of Short Form -12(Enrollment, 3 months, 6 months, 12 months)
研究者
研究点 (57)
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