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

University Hospital Center (CHU)

Status and phase: Completed; Phase 3

Conditions: Modic I Discopathy; Lumbago; Low Back Pain

Treatments: Drug: Lidocaine; Drug: Hydrocortancyl.

Study type: Interventional

Funder types: Other

Identifiers

NCT01694134

8833

Details and patient eligibility

About

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.

Full description

This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Corticoids

Active Comparator group

Description:

A group of patients will receive an intradiscal injection of Hydrocortancyl.

Treatment:

Drug: Hydrocortancyl.

Local anaesthetic

Sham Comparator group

Description:

A group of patients will receive an intradiscal injection of Lidocaine.

Treatment:

Drug: Lidocaine