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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00804531
First received: December 8, 2008
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Back Pain Lower Back Chronic
Drug: Visipaque - Hydrocortancyl
Drug: Placebo comparator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain level at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Disability (Quebec questionnaire) [ Time Frame: 1 month and 12 months ] [ Designated as safety issue: No ]
  • quality of life (SF-12) at 1 and 12 months [ Time Frame: 1 month and 12 months ] [ Designated as safety issue: No ]
  • anxiety and depression (HAD) [ Time Frame: 1 month and 12 months ] [ Designated as safety issue: No ]
  • fears-avoidance beliefs (FABQ) [ Time Frame: 1 month and 12 months ] [ Designated as safety issue: No ]
  • coping strategies (CSQ) [ Time Frame: 1 month and 12 months ] [ Designated as safety issue: No ]
  • disc height (on lateral radiography), [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • disc inflammation (on MRI) at 12 month [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 101
Study Start Date: October 2008
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Visipaque - Hydrocortancyl
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
Other Name: Placebo comparator

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), fears-avoidance beliefs (FABQ), coping strategies (CSQ), disc height (on lateral radiograph), 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804531

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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00804531     History of Changes
Other Study ID Numbers: P070157
Study First Received: December 8, 2008
Last Updated: January 10, 2014
Health Authority: France: Ministry of Health

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
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Iodixanol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contrast Media

ClinicalTrials.gov processed this record on October 19, 2014