NCT04826757 Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering From Low Back Pain in Primary Care
| NCT ID | NCT04826757 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-09-21 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2022-09-21 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Aline RAMOND ROQUIN, MD-PHD
PRINCIPAL INVESTIGATOR
Department of Family Medicine - University of Angers
Frequently Asked Questions
Who can join the NCT04826757 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04826757 currently recruiting?
Yes, NCT04826757 is actively recruiting participants. Contact the research team at aline.ramond@univ-angers.fr for enrollment information.
Where is the NCT04826757 trial being conducted?
This trial is being conducted at Bonchamp-lès-Laval, France, Breteil, France, Brûlon, France, Château-Gontier, France and 11 additional locations.
Who is sponsoring the NCT04826757 clinical trial?
NCT04826757 is sponsored by University Hospital, Angers. The principal investigator is Aline RAMOND ROQUIN, MD-PHD at Department of Family Medicine - University of Angers. The trial plans to enroll 500 participants.