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

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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

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


Condition or disease Intervention/treatment Phase
Back Pain Lower Back Chronic Drug: Visipaque - Hydrocortancyl Drug: Placebo comparator Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial
Study Start Date : April 2009
Actual Primary Completion Date : May 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
Drug Information available for: Iodixanol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Visipaque - Hydrocortancyl
Administration of two treatments for the experimental arm
Drug: Visipaque - Hydrocortancyl
Visipaque 320 mg I/ml - 1 ml intra-discal route Hydrocortancyl 25 mg/ml - 1 ml intra-discal route
Placebo Comparator: Visipaque
Administration of only one treatment in intra discal of visipaque
Drug: Placebo comparator
Visipaque - 320 mg I/ml - 1 ml in intra-discal route



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. pain level at 12 months [ Time Frame: 12 months ]
  2. Disability (Quebec questionnaire) [ Time Frame: 1 month and 12 months ]
  3. quality of life (SF-12) at 1 and 12 months [ Time Frame: 1 month and 12 months ]
  4. anxiety and depression (HAD) [ Time Frame: 1 month and 12 months ]
  5. disc inflammation (on MRI) at 12 month [ Time Frame: 12 months ]
  6. analgesics and anti-inflammatories during the last week [ Time Frame: 1 month and 12 months ]
  7. return to work [ Time Frame: 1 month and 12 months ]
  8. Assessment of the disabilities (scale of 6 classes) [ Time Frame: 1 month and 12 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00804531


Locations
France
Hôpital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Serge Poiraudeau, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications of Results:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00804531     History of Changes
Other Study ID Numbers: P070157
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: May 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Low back pain
steroid injection
inter-vertebral disc
randomized trial
Lack of efficacy of usual recommended treatments
More than 40 on the pain numeric scale (0-100)
Inflammatory discopathy (MODIC I) on MRI

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents