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

Low Back Pain Clinical Trial

— IPAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615597
• Other study ID #: RECHMPL22_0230
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: December 22, 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: Arthur HAMEL SENECAL, MD
• Phone: 0467338946
• Email: arthur.hamelsenecal[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 22, 2025
• Est. primary completion date: July 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (ßHCG 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

Related Conditions & MeSH terms

• Back Pain
• Degenerative Disc Disease
• Inflammation
• Intervertebral Disc Degeneration
• Low Back Pain
• Spinal Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Departement of Medical Imaging	Montpellier	Occitanie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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