Intra-discal Steroid Injection for MODIC I Discopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2015-11-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Back Pain Lower Back Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Visipaque - Hydrocortancyl

Administration of two treatments for the experimental arm

Group Type EXPERIMENTAL

Visipaque - Hydrocortancyl

Intervention Type DRUG

Visipaque 320 mg I/ml - 1 ml intra-discal route Hydrocortancyl 25 mg/ml - 1 ml intra-discal route

Visipaque

Administration of only one treatment in intra discal of visipaque

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DRUG

Visipaque - 320 mg I/ml - 1 ml in intra-discal route

Interventions

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Visipaque - Hydrocortancyl

Visipaque 320 mg I/ml - 1 ml intra-discal route Hydrocortancyl 25 mg/ml - 1 ml intra-discal route

Intervention Type DRUG

Placebo comparator

Visipaque - 320 mg I/ml - 1 ml in intra-discal route

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No