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Trial record 7 of 14 for:    "Spinal Disease" | "Methylprednisolone"

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

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ClinicalTrials.gov Identifier: NCT01694134
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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.
Actual Study Start Date : July 12, 2012
Actual Primary Completion Date : March 20, 2017
Actual Study Completion Date : March 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Steroids

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Pain assessment: VAS [ Time Frame: 1 months ]
    The pain will be assessed by the visual analog scale (VAS).


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

  2. Consumption of analgesics and NSAIDs assessment [ Time Frame: 6 months ]
  3. Specific low back pain parameters assessment [ Time Frame: 6 months ]
    Low back pain parameters will be assessed by the Dallas scale.The Dallas Pain Questionnaire (DPQ) assesses the impact of low back pain (LBP) on four components (0-100) of daily life .

  4. 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. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

  5. Employment status [ Time Frame: 6 months ]
    Employment or non-employment status will be noted



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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


Locations
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France
Hospital University of Montpellier
Montpellier, France, 34000
Sponsors and Collaborators
University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01694134     History of Changes
Other Study ID Numbers: 8833
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Keywords provided by University Hospital, Montpellier:
Discopathy
Modic I
Corticoids
Local Anaesthetic
Intradiscal injection
Additional relevant MeSH terms:
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Spinal Diseases
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Intervertebral Disc Displacement
Intervertebral Disc Degeneration
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Lidocaine
Anesthetics
Anesthetics, Local
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
Membrane Transport Modulators