Intra-Discal Steroid Injection for MODIC I Discopathy - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00804531

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
Chronic Low Back Pain	Drug: Visipaque - Hydrocortancyl Drug: Placebo comparator	Phase IV

MedlinePlus related topics: Ataxia Telangiectasia Back Pain

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Iodixanol Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Intra-Discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial

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 ]

Estimated Enrollment:	134
Study Start Date:	October 2008
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Visipaque - Hydrocortancyl: Experimental 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
Visipaque: Placebo Comparator Administration of only one treatment in intra discal of visipaque	Drug: Placebo comparator Visipaque - 320 mg I/ml - 1 ml in intra-discal route

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 60 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
Written informed consent
Social security
Medical examination

Non inclusion criteria :

Pregnancy
Hypersensitivity to methylprednisolone or contrast
Local or general infection
Previous disc surgery
Previous disc nucleolysis
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

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:	Department Clinical Research of Developpement ( Amel Ouslimani )
Study ID Numbers:	P070157, EUDRACT N° : 2008-001576-79
Study First Received:	December 8, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00804531 History of Changes
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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Low Back Pain
Methylprednisolone acetate
Antiemetics
Pain
Prednisolone acetate

Hormones
Glucocorticoids
Neuroprotective Agents
Back Pain
Signs and Symptoms
Prednisolone
Neurologic Manifestations
Peripheral Nervous System Agents
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Pain
Neuroprotective Agents
Hormones
Signs and Symptoms
Therapeutic Uses
Methylprednisolone Hemisuccinate
Antineoplastic Agents, Hormonal

Nervous System Diseases
Gastrointestinal Agents
Methylprednisolone acetate
Low Back Pain
Back Pain
Protective Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Prednisolone
Neurologic Manifestations
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009