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

This study is currently recruiting participants.
Verified May 2016 by University Hospital, Montpellier
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694134
First Posted: September 26, 2012
Last Update Posted: June 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose
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.

Condition Intervention Phase
Low Back Pain Lumbago Modic I Discopathy Drug: Hydrocortancyl. Drug: Lidocaine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Pain assessment [ Time Frame: 6 months ]
    The pain will be assessed by the visual analog scale (VAS).


Secondary Outcome Measures:
  • Quality of life assessment [ Time Frame: 6 months ]
    Quality of life will be assessed by the self-questionnaire SF-36.

  • Consumption of analgesics and NSAIDs assessment [ Time Frame: 6 months ]
  • Specific low back pain parameters assessment [ Time Frame: 6 months ]
    Low back pain parameters will be assessed by the Dallas scale and the Oswestry scale.


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Corticoids
A group of patients will receive an intradiscal injection of Hydrocortancyl.
Drug: Hydrocortancyl.
Patients will receive an intradiscal injection of hydrocortancyl.
Sham Comparator: Local anaesthetic
A group of patients will receive an intradiscal injection of Lidocaine.
Drug: Lidocaine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694134


Contacts
Contact: Isabelle Tavares, MD +334 67 33 88 26 i-tavaresfigueiredo@chu-montpellier.fr

Locations
France
Hospital University of Montpellier Recruiting
Montpellier, France, 34000
Contact: Isabelle Tavares, MD    +334 67 33 88 26    i-tavaresfigueiredo@chu-montpellier.fr   
Principal Investigator: Isabelle Tavares, MD         
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01694134     History of Changes
Other Study ID Numbers: 8833
First Submitted: September 22, 2012
First Posted: September 26, 2012
Last Update Posted: June 1, 2016
Last Verified: May 2016

Keywords provided by University Hospital, Montpellier:
Discopathy
Modic I
Corticoids
Local Anaesthetic
Intradiscal injection

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Back Pain
Low Back Pain
Intervertebral Disc Degeneration
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Lidocaine
Anesthetics, Local
Anesthetics
Methylprednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers