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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-12

Study Completion Date

2017-03-20

Brief Summary

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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.

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Detailed Description

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

Conditions

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Low Back Pain Lumbago Modic I Discopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Corticoids

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

Group Type ACTIVE_COMPARATOR

Hydrocortancyl.

Intervention Type DRUG

Patients will receive an intradiscal injection of hydrocortancyl.

Local anaesthetic

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

Group Type SHAM_COMPARATOR

Lidocaine

Intervention Type DRUG

Interventions

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Hydrocortancyl.

Patients will receive an intradiscal injection of hydrocortancyl.

Intervention Type DRUG

Lidocaine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No