Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease

NCT05615597 | Recruiting

• 1 other identifier: RECHMPL22_0230
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease; Inflammation; Low Back Pain

Keywords

Low back pain; Injections; Degenerative Disc Disease; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Concomitant treatments (analgesics/NSAIDs)

  up to 6 months

• Change from The Oswestry Disability Index (ODI) at 1 month

  1 month after intervention

• Change from Baseline Pain using the Visual Analogue Scale (VAS) at 7 days

  7 days after intervention

• Change from Baseline Pain using the Visual Analogue Scale (VAS) at 3 months

  3 months after intervention

• Change from Baseline Pain using the Visual Analogue Scale (VAS) at 6 months

  6 months after intervention

Study Arms (1)

Para-discal infiltration

OTHER

Single arm study

Procedure: Para-discal injection of corticoid

Interventions

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.

Para-discal infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Departement of Medical Imaging

Montpellier, Occitanie, 34295, France

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Inflammation; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Arthur HAMEL-SENECAL, MD

  Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur HAMEL SENECAL, MD

CONTACT

0467338946; arthur.hamelsenecal@chu-montpellier.fr

Catherine CYTEVAL, MD, PhD

CONTACT

c-cyteval@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 14, 2022
• Study Start: December 22, 2022
• Primary Completion: July 22, 2025
• Study Completion: December 22, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

FR (1)