Efficacy of Lumbar Immobilisation by Rigid Brace for Chronic Low Back Pain Patients With Modic 1 Changes (DICO)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be recruited if aged between 18 and 55 years old and suffering from chronic lumbar pain (Visual Analogic Scale (VAS) > 3) associated with Modic type I changes diagnosed with a MRI achieved less than 6 months before the consultation and interpreted by a radiologist specialised in spine disease. Patients must also be capable of giving a clear consent. Will not be included patients suffering from other types of Modic change, or any other cause of back pain such as spondylolisthesis, fracture, spondylitis, scoliosis, rheumatoid arthritis and also patient not willing to wear the brace for at least 3 months. Patients will be recruited from the consultation in PMR units across 5 centres in France.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
This will be a 2 parallel group multicentre randomised controlled trial. Patients will undergo 3 consultations with the physician, based on the usual follow up for this pathology. During the first consultation the physician will check the inclusion criteria, medical history, clinical data relative t...
This will be a 2 parallel group multicentre randomised controlled trial. Patients will undergo 3 consultations with the physician, based on the usual follow up for this pathology. During the first consultation the physician will check the inclusion criteria, medical history, clinical data relative to the different outcomes, and prescribe optimizated pain killers and deliver information about self care and physical activity. Patient reported outcome measures will be assessed through self answering questionnaires with the help of a research assistant if necessary. After randomisation the prosthetist will take the measurement to conceive the custom brace. Patients will then be re-examined during a 2nd consultation 3 month later to assess the main outcome (pain reduction) and other secondary outcome (proms). A third consultation will be organised 6 months later for secondary outcome (pain reduction and proms).
Tracking Information
- NCT #
- NCT04191161
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Emmanuel Coudeyre University Hospital, Clermont-Ferrand
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