Clinical trial NCT05615597: Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease
Official title: Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease: Pilot Study (IPAD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Inflammation
Low Back Pain
Keywords: Low back pain
Injections
Degenerative Disc Disease
Inflammation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patient 18 years of age or older
* Patient with Modic I lateralized disc disease seen on an MRI less than 6 months old.
* Chronic medial or lateralized (same side as MODIC 1) low back pain for at least 3 months with a mean pain intensity ≥ 40/100 mm on a VAS.
* Effective contraception for women of childbearing age, at least 6 months after injection (surgical sterilisation, approved hormonal contraceptives, barrier methods, intrauterine intrauterine device)

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 :

  * current and recent morphine use (\< 1 month)
  * recent systemic or local corticosteroid therapy (\< 1 month).
* 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

Primary outcomes:
measure: Change from Baseline pain using the Visual Analogue Scale (VAS) at 1 month
timeFrame: 1 month after intervention
Secondary outcomes:
measure: Concomitant treatments (analgesics/NSAIDs)
timeFrame: up to 6 months
measure: Change from The Oswestry Disability Index (ODI) at 1 month
timeFrame: 1 month after intervention
measure: Change from Baseline Pain using the Visual Analogue Scale (VAS) at 7 days
timeFrame: 7 days after intervention
measure: Change from Baseline Pain using the Visual Analogue Scale (VAS) at 3 months
timeFrame: 3 months after intervention
measure: Change from Baseline Pain using the Visual Analogue Scale (VAS) at 6 months
timeFrame: 6 months after intervention
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Departement of Medical Imaging
state: Occitanie
Study officials:
affiliation: Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital
name: Arthur HAMEL-SENECAL, MD
role: PRINCIPAL_INVESTIGATOR
References: