Efficacy of Lumbar Immobilisation by Rigid Brace for Chronic Low Back Pain Patients With Modic 1 Changes (DICO)
TerminatedNot applicableNCT04191161
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Chronic low back pain may be associated with active discopathy. This subset of individuals are defined by a clinical and radiological syndrome with specific MRI signals, known as MODIC changes. Three types (I, II and III) of MODIC changes are described. Type I refers to the inflammatory reaction regarding the intervertebral-disc subchondral bone and adjacent vertebral-endplate subchondral bone. The natural evolution of this active discopathy will lead to sclerosis (type III) supposedly less painful. So far the underlying mechanism remains unclear and debated (mechanical, local infection, genetic). In the absence of international guidelines on the management on chronic low back pain with MC type 1, different therapeutic strategies have been described. The main goal is to accelerate the transition to MC type 2, which is supposedly less painful. The estimated time to expect a transition from type 1 to type 2 is at least 1 year. The mechanical hypothesis found its origin in the Modic et al. initial study, linking Modic changes (MC) types 1 and 2 to degenerative disc disease. The Histological analysis of patient suffering from active discopathy has shown signs of micro fractures regarding vertebral endplates. The local inflammatory reaction may be part of a repair process following the micro fracture. Based on this mechanical explanation an orthopaedic treatment with a lumbar brace may accelerate the healing, thus the transition from modic I to type II. This approach has been studied in a retrospective analysis on 62 patients suffering from active discopathy (modic type I) who were prescribed a custom lumbar rigid brace for 3 months, at endpoint 80% of the patients treated described a reduction of at least 30% of their initial pain. This study aims to confirm the previous hypothesis, that lumbar immobilisation by custom rigid brace can reduce the pain after being worn for 3 months. Secondary objective will be to assess the pain reduction at 6 months along with functional…
Study details
- Official title
- Efficacy of Lumbar Immobilisation by Rigid Brace for Chronic Low Back Pain Patients With Modic 1 Changes
- Conditions
- Interventions
- Device: Wearing the rigid brace
- Sponsor
- University Hospital, Clermont-Ferrand
- Start date
- 2021-04-12
- Primary completion
- 2022-09-15
- Sex
- All
- Age range
- from 18 Years to 55 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: \-- Age: \> 18 years \< 55 years * Patient affiliated to a social security scheme ( beneficiary entitled ) * Patient has given its consent in writing to participate in the study * Low back pain associated with a MODIC I signal at the lumbar stage objectified by an MRI dated less than 6 months and confirmed by a radiologist. Exclusion Criteria: * Other types of Modic change * 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 * Pregnancy
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04191161