Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Sufferin… (NCT04826757) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering From Low Back Pain in Primary Care
France500 participantsStarted 2022-09-21
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.