Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies. (NCT01694134) | Clinical Trial Compass
CompletedPhase 3
Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.
France50 participantsStarted 2012-07-12
Plain-language summary
The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. In this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a Modic I discopathy.
Who can participate
Age range
18 Years – 80 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:
* Age between 18 and 80 years
* Signed Informed consent
* Low back pain for more than 6 months associated with Modic I discopathy (diagnosed by MRI)
Exclusion Criteria:
* Past history of lumbar surgery
* Patient under anticoagulant or antisludge treatment, or with coagulation troubles
* Patient with unbalanced diabetes mellitus (blood glucose \> 1.30 g/l)
* Patient with unstabilized high blood pressure (\> 160/95 mmHg)
* Patient with evolving infection
* Patient with iodine allergy or one of the Hydrocortancyl® or Lidocaine components
* Porphyria, hypersensitivity to local anaesthetic
* Patient with sphincter troubles showing a cauda equine syndrome
* Untreated psychotic state
* Pregnant women or of childbearing age without effective contraception means
* Impossible 6 months follow-up
* Participation to another trial
* Vulnerable persons protected by the law
* Persons under guardianship
* Persons unable to express their consent
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.