Actively Recruiting
Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease
Led by University Hospital, Montpellier · Updated on 2024-05-29
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Degenerative disc disease (DDD) is a major cause of chronic low back pain (\> 40%). It can be defined by specific magnetic resonance imaging (MRI) features, with a strong correlation between pain and the inflammatory aspect of the disc, resulting in active disc disease (AD). The Modic classification based on MRI of the lumbar spine is considered a reference. The management of low back pain in patients with inflammatory disc disease generally involves intra-disc corticosteroid infiltration, which has been widely proven to be effective in reducing pain \[4-6\]. However, this procedure can be painful and invasive and sometimes impossible to perform due to severe disc impingement. The aim of this study is to evaluate the efficacy on pain of para-disc infiltration of corticosteroids in contact with the inflammatory MRI signal abnormality (Modic 1) when it is lateralized. This variant of infiltration is easier to perform (no catheterisation of the disc and therefore quicker), would entail less risk of disc infection and would be accessible to more radiologists. It is already practised but, to our knowledge, has never been the subject of a study to evaluate its effectiveness on pain. If successful, more patients could be treated and the range of treatment could be extended.
CONDITIONS
Official Title
Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years of age or older
- Modic I lateralized disc disease seen on an MRI less than 6 months old
- Chronic medial or lateralized low back pain for at least 3 months with a mean pain intensity 40/100 mm on a Visual Analogue Scale
- Effective contraception for women of childbearing age, at least 6 months after injection (surgical sterilisation, approved hormonal contraceptives, barrier methods, intrauterine device)
You will not qualify if you...
- Modic 1 in both underlying and overlying vertebral spaces
- Inflammatory signal abnormality of the vertebral body plateau related to non-mechanical pathology (e.g. spondyloarthritis)
- History of lumbar spine surgery
- Suspected spondylodiscitis or other infection
- On anticoagulant or antiaggregant therapy, or with a coagulation disorder
- Allergy to iodine or any components of Xylocaine
- Allergy to prednisolone or any component of Hydrocortancyl4 or Dexamethasone4
- Severe uncontrolled disease limiting patient safety (cardiac, gastrointestinal, neurological, endocrine, autoimmune)
- Current or recent morphine use (< 1 month)
- Recent systemic or local corticosteroid therapy (< 1 month)
- Sphincter disturbances indicative of cauda equina syndrome
- Uncontrolled psychotic state
- Pregnancy (HCG positive) or breastfeeding
- Vulnerable patient protected by law
- Under guardianship or curatorship
- Participating in another interventional study
- Unable to read and/or write
AI-Screening
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Trial Site Locations
Total: 1 location
1
Departement of Medical Imaging
Montpellier, Occitanie, France, 34295
Actively Recruiting
Research Team
A
Arthur HAMEL SENECAL, MD
CONTACT
C
Catherine CYTEVAL, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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