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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Para-discal infiltration | Other | Single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Para-discal injection of corticoid | Procedure | In this pilot study, all patients underwent the same procedure: a corticosteroid infiltration via a para-discal approach. The infiltrations were performed under CT or scopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline pain using the Visual Analogue Scale (VAS) at 1 month | VAS pain is a subjective but simple and reproducible criterion and one of the most widely used to evaluate the effectiveness of a therapeutic strategy in chronic low back pain. 0 represents no pain and 100 represents the worst pain imaginable. | 1 month after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Concomitant treatments (analgesics/NSAIDs) | he use of analgesics or NSAIDs will be recorded throughout the study by direct questioning of the patient and/or through their medical records. | up to 6 months |
| Change from The Oswestry Disability Index (ODI) at 1 month |
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Inclusion Criteria:
Exclusion Criteria:
Patient with MODIC 1 in both underlying and overlying vertebral spaces.
Patient with an inflammatory signal abnormality of the vertebral body plateau related to non-mechanical pathology (e.g. spondyloarthritis).
Patients with a history of lumbar spine surgery.
Patient with suspected spondylodiscitis or other infection.
Patients on anticoagulant or antiaggregant therapy, or with a coagulation disorder.
Patients with an allergy to iodine or to any of the components of Xylocaine.
Patients with an allergy to prednisolone or to any component of Hydrocortancyl® or Dexamethasone®..
Patient with severe uncontrolled disease (i.e. cardiac gastrointestinal, neurological, endocrine, autoimmune) that limits patient safety (as determined by the safety (as judged by the investigator).
Prior to the treatment visit :
Patient with sphincter disturbances indicative of cauda equina syndrome.
Psychotic state not controlled by treatment
Pregnancy (βHCG positive), breastfeeding
Vulnerable patient protected by law
Patient under guardianship or curatorship
Patient participating in an interventional study
Patient unable to read and/or write
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur HAMEL SENECAL, MD | Contact | 0467338946 | +33 | arthur.hamelsenecal@chu-montpellier.fr |
| Catherine CYTEVAL, MD, PhD | Contact | +33 | c-cyteval@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Arthur HAMEL-SENECAL, MD | Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement of Medical Imaging | Recruiting | Montpellier | Occitanie | 34295 | France |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D007249 | Inflammation |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
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The Oswestry Disability Index (ODI) is a validated questionnaire (Fairbank and Pynsent 2000). We will consider a patient as responder if he/she manages to achieve at least 30% improvement in ODI score between baseline and 1 month. This percentage of minimal improvement (30%) was judged to be a clinically relevant threshold by an international consensus conference (Ostelo et al. 2008). |
| 1 month after intervention |
| Change from Baseline Pain using the Visual Analogue Scale (VAS) at 7 days | VAS pain is a subjective but simple and reproducible criterion and one of the most widely used to evaluate the effectiveness of a therapeutic strategy in chronic low back pain. 0 represents no pain and 100 represents the worst pain imaginable. | 7 days after intervention |
| Change from Baseline Pain using the Visual Analogue Scale (VAS) at 3 months | VAS pain is a subjective but simple and reproducible criterion and one of the most widely used to evaluate the effectiveness of a therapeutic strategy in chronic low back pain. 0 represents no pain and 100 represents the worst pain imaginable. | 3 months after intervention |
| Change from Baseline Pain using the Visual Analogue Scale (VAS) at 6 months | VAS pain is a subjective but simple and reproducible criterion and one of the most widely used to evaluate the effectiveness of a therapeutic strategy in chronic low back pain. 0 represents no pain and 100 represents the worst pain imaginable. | 6 months after intervention |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |