Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.

• Status: Completed
• Trial end date: 2017-03-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: Anesthetics; Anesthetics, Local; Lidocaine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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