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Intra-discal Steroid Injection for MODIC I Discopathy (PREDID)

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: NCT00804531
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE December 8, 2008
First Posted Date  ICMJE December 9, 2008
Last Update Posted Date August 14, 2017
Study Start Date  ICMJE April 2009
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
Back pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2008)
Pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month [ Time Frame: 1 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
  • pain level at 12 months [ Time Frame: 12 months ]
  • Disability (Quebec questionnaire) [ Time Frame: 1 month and 12 months ]
  • quality of life (SF-12) at 1 and 12 months [ Time Frame: 1 month and 12 months ]
  • anxiety and depression (HAD) [ Time Frame: 1 month and 12 months ]
  • disc inflammation (on MRI) at 12 month [ Time Frame: 12 months ]
  • analgesics and anti-inflammatories during the last week [ Time Frame: 1 month and 12 months ]
  • return to work [ Time Frame: 1 month and 12 months ]
  • Assessment of the disabilities (scale of 6 classes) [ Time Frame: 1 month and 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2008)
  • pain level at 12 months [ Time Frame: 12 months ]
  • Disability (Quebec questionnaire) [ Time Frame: 1 month and 12 months ]
  • quality of life (SF-12) at 1 and 12 months [ Time Frame: 1 month and 12 months ]
  • anxiety and depression (HAD) [ Time Frame: 1 month and 12 months ]
  • fears-avoidance beliefs (FABQ) [ Time Frame: 1 month and 12 months ]
  • coping strategies (CSQ) [ Time Frame: 1 month and 12 months ]
  • disc height (on lateral radiography), [ Time Frame: 12 months ]
  • disc inflammation (on MRI) at 12 month [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-discal Steroid Injection for MODIC I Discopathy
Official Title  ICMJE Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial
Brief Summary

To assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on magnetic resonance imaging.

Hypothesis: delivering anti-inflammatory drugs in situ may decrease back pain in patients with inflammatory discopathy

Detailed Description

Objective: to assess the efficacy on pain level of a steroid injection in the inter-vertebral disc for patients with chronic back pain and MODIC I discopathy on MRI

Methods: a multicenter double blind randomized control trial Setting: 3 tertiary care hospitals in France Patients: 134 patients with disabling chronic low back pain not relieved by usual recommended treatments and MODIC I (inflammatory) discopathy on MRI Intervention: Injection of 25 mg of methylprednisolone in the inter-vertebral disc during a discography (intervention group, 67 patients) or discography alone (control group, 67 patients) Outcome measures: The primary outcome measure is pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month. Secondary outcome measures are pain level at 12 months, Disability (Quebec questionnaire), quality of life (SF-12) at 1 and 12 months, anxiety and depression (HAD), analgesics and anti-inflammatories during the last week, return to work, assessment of the disabilities at 1 and 12 months and disc inflammation (on MRI) at 12 months. Tolerance and adverse effects will be recorded.

Trial duration: 36 months(24 months for inclusion and 12 months follow-up) Follow-up visits: at 1, 3, 6, and 12 months Statistical analysis: intention to treat

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Back Pain Lower Back Chronic
Intervention  ICMJE
  • Drug: Visipaque - Hydrocortancyl
    Visipaque 320 mg I/ml - 1 ml intra-discal route Hydrocortancyl 25 mg/ml - 1 ml intra-discal route
  • Drug: Placebo comparator
    Visipaque - 320 mg I/ml - 1 ml in intra-discal route
Study Arms  ICMJE
  • Experimental: Visipaque - Hydrocortancyl
    Administration of two treatments for the experimental arm
    Intervention: Drug: Visipaque - Hydrocortancyl
  • Placebo Comparator: Visipaque
    Administration of only one treatment in intra discal of visipaque
    Intervention: Drug: Placebo comparator
Publications *

*   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: April 20, 2015)
137
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2008)
134
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • More than 18 and less than 70 years old
  • Low back pain
  • Daily pain for at least 3 months
  • Pain level during the last 48 hours > 40 on the numeric pain scale (0-100)
  • Lack of efficacy of usual recommended treatments and of other spine steroid injections (epidural or facet joints injections)
  • Modic I discopathy on MRI
  • Intra-discal injection at least 6 months before inclusion
  • Written informed consent
  • Social security
  • Medical examination

Non inclusion criteria :

  • Pregnancy
  • Hypersensitivity to methylprednisolone or contrast
  • Local or general infection
  • Previous disc surgery less than 6 months
  • Steroid treatment
  • Previous infectious spondylodiscitis
  • Ankylosing spondylitis
  • Sciatica with neurologic defects
  • Uncontrolled psychiatric conditions
  • Inability to read or understand French language
  • Anti-vitamin K treatments
  • Severe coagulation diseases
  • Fever > 38 or sedimentation rate > 20
  • Discopathy with MODIC 1 signal on several different lumbar stages
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 NCT00804531
Other Study ID Numbers  ICMJE P070157
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Serge Poiraudeau, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2016

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