CompletedPhase 4

Intra-discal Steroid Injection for MODIC I Discopathy

France137 participantsStarted 2009-04

Plain-language summary

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

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 month

Trial details

NCT IDNCT00804531

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-05

View on ClinicalTrials.gov More Back Pain Lower Back Chronic trials