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Trial record 9 of 21 for:    "Bone Disease" | "Methylprednisolone"

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01694134
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE September 22, 2012
First Posted Date  ICMJE September 26, 2012
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE July 12, 2012
Actual Primary Completion Date March 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
Pain assessment: VAS [ Time Frame: 1 month ]
The pain will be assessed by the visual analog scale (VAS).
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
Pain assessment [ Time Frame: 6 months ]
The pain will be assessed by the visual analog scale (VAS).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Pain assessment: VAS [ Time Frame: 1 week, 2 weeks, 3 weeks, 3 months, 6 months ]
    The pain will be assessed by the visual analog scale (VAS).
  • Quality of life assessment: SF-36 [ Time Frame: 1 month, 3 months, 6 months ]
    Quality of life will be assessed by the self-questionnaire SF-36.
  • Consumption of analgesics and NSAIDs assessment [ Time Frame: 1 month, 3 months,6 months ]
  • Specific low back pain parameters assessment [ Time Frame: 1 month, 3 months,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 .
  • Specific low back pain parameters assessment [ Time Frame: 1 month, 3 months,6 months ]
    Low back pain parameters will be assessed by 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.
  • Employment status [ Time Frame: 1 month, 3 months,6 months ]
    Employment or non-employment status will be noted
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.
Official Title  ICMJE Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.
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.
Detailed Description This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Low Back Pain
  • Lumbago
  • Modic I Discopathy
Intervention  ICMJE
  • Drug: Hydrocortancyl.
    Patients will receive an intradiscal injection of hydrocortancyl.
  • Drug: Lidocaine
Study Arms  ICMJE
  • Active Comparator: Corticoids
    A group of patients will receive an intradiscal injection of Hydrocortancyl.
    Intervention: Drug: Hydrocortancyl.
  • Sham Comparator: Local anaesthetic
    A group of patients will receive an intradiscal injection of Lidocaine.
    Intervention: Drug: Lidocaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2019)
50
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2012)
40
Actual Study Completion Date  ICMJE March 20, 2017
Actual Primary Completion Date March 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01694134
Other Study ID Numbers  ICMJE 8833
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Montpellier
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP