Intra-discal Steroid Injection for MODIC I Discopathy (PREDID)

Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial

To assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on magnetic resonance imaging.

Hypothesis: delivering anti-inflammatory drugs in situ may decrease back pain in patients with inflammatory discopathy

Study Overview

• Status: Completed
• Conditions: Back Pain Lower Back Chronic
• Intervention / Treatment: Drug: Visipaque - Hydrocortancyl; Drug: Placebo comparator

Detailed Description

Objective: to assess the efficacy on pain level of a steroid injection in the inter-vertebral disc for patients with chronic back pain and MODIC I discopathy on MRI

Methods: a multicenter double blind randomized control trial Setting: 3 tertiary care hospitals in France Patients: 134 patients with disabling chronic low back pain not relieved by usual recommended treatments and MODIC I (inflammatory) discopathy on MRI Intervention: Injection of 25 mg of methylprednisolone in the inter-vertebral disc during a discography (intervention group, 67 patients) or discography alone (control group, 67 patients) Outcome measures: The primary outcome measure is pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month. Secondary outcome measures are pain level at 12 months, Disability (Quebec questionnaire), quality of life (SF-12) at 1 and 12 months, anxiety and depression (HAD), analgesics and anti-inflammatories during the last week, return to work, assessment of the disabilities at 1 and 12 months and disc inflammation (on MRI) at 12 months. Tolerance and adverse effects will be recorded.

Trial duration: 36 months(24 months for inclusion and 12 months follow-up) Follow-up visits: at 1, 3, 6, and 12 months Statistical analysis: intention to treat

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Hôpital Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria :

• More than 18 and less than 70 years old
• Low back pain
• Daily pain for at least 3 months
• Pain level during the last 48 hours > 40 on the numeric pain scale (0-100)
• Lack of efficacy of usual recommended treatments and of other spine steroid injections (epidural or facet joints injections)
• Modic I discopathy on MRI
• Intra-discal injection at least 6 months before inclusion
• Written informed consent
• Social security
• Medical examination

Non inclusion criteria :

• Pregnancy
• Hypersensitivity to methylprednisolone or contrast
• Local or general infection
• Previous disc surgery less than 6 months
• Steroid treatment
• Previous infectious spondylodiscitis
• Ankylosing spondylitis
• Sciatica with neurologic defects
• Uncontrolled psychiatric conditions
• Inability to read or understand French language
• Anti-vitamin K treatments
• Severe coagulation diseases
• Fever > 38 or sedimentation rate > 20
• Discopathy with MODIC 1 signal on several different lumbar stages

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visipaque - Hydrocortancyl; Administration of two treatments for the experimental arm	Drug: Visipaque - Hydrocortancyl; Visipaque 320 mg I/ml - 1 ml intra-discal route Hydrocortancyl 25 mg/ml - 1 ml intra-discal route
Placebo Comparator: Visipaque; Administration of only one treatment in intra discal of visipaque	Drug: Placebo comparator; Visipaque - 320 mg I/ml - 1 ml in intra-discal route

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Back pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
pain level at 12 months	12 months
Disability (Quebec questionnaire)	1 month and 12 months
quality of life (SF-12) at 1 and 12 months	1 month and 12 months
anxiety and depression (HAD)	1 month and 12 months
disc inflammation (on MRI) at 12 month	12 months
analgesics and anti-inflammatories during the last week	1 month and 12 months
return to work	1 month and 12 months
Assessment of the disabilities (scale of 6 classes)	1 month and 12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Unité de Recherche Clinique Necker Cochin, France
• Investigators: Principal Investigator: Serge Poiraudeau, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Nguyen C, Boutron I, Baron G, Sanchez K, Palazzo C, Benchimol R, Paris G, James-Belin E, Lefevre-Colau MM, Beaudreuil J, Laredo JD, Bera-Louville A, Cotten A, Drape JL, Feydy A, Ravaud P, Rannou F, Poiraudeau S. Intradiscal Glucocorticoid Injection for Patients With Chronic Low Back Pain Associated With Active Discopathy: A Randomized Trial. Ann Intern Med. 2017 Apr 18;166(8):547-556. doi: 10.7326/M16-1700. Epub 2017 Mar 21.
• Daste C, Abdoul H, Foissac F, Lefevre-Colau MM, Poiraudeau S, Rannou F, Nguyen C. Patient acceptable symptom state for patient-reported outcomes in people with non-specific chronic low back pain. Ann Phys Rehabil Med. 2022 Jan;65(1):101451. doi: 10.1016/j.rehab.2020.10.005. Epub 2020 Nov 26.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: December 8, 2008
• First Submitted That Met QC Criteria: December 8, 2008
• First Posted (Estimated): December 9, 2008

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Low back pain; randomized trial; steroid injection; inter-vertebral disc; Lack of efficacy of usual recommended treatments; More than 40 on the pain numeric scale (0-100); Inflammatory discopathy (MODIC I) on MRI
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: P070157