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

Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease: Pilot Study (IPAD)

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Low Back Pain; Degenerative Disc Disease
• Intervention / Treatment: Procedure: Para-discal injection of corticoid

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arthur HAMEL SENECAL, MD; Phone Number: +33 0467338946; Email: arthur.hamelsenecal@chu-montpellier.fr
• Study Contact Backup: Name: Catherine CYTEVAL, MD, PhD; Email: c-cyteval@chu-montpellier.fr

Study Locations

• France
  • Occitanie
    • Montpellier, Occitanie, France, 34295
      • Recruiting
      • Departement of Medical Imaging
      • Contact: Celine ENGRAND; Email: c-engrand@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Para-discal infiltration; Single arm study	Procedure: Para-discal injection of corticoid; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Arthur HAMEL-SENECAL, MD, Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Estimated): July 22, 2025
• Study Completion (Estimated): December 22, 2025

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Inflammation; Low back pain; Injections; Degenerative Disc Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Bone Diseases; Back Pain; Low Back Pain; Inflammation; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: RECHMPL22_0230

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No