Intra-discal Steroid Injection for MODIC I Discopathy

Phase 4

Completed

• Conditions: Back Pain Lower Back Chronic
• Interventions: Drug: Placebo comparator; Drug: Visipaque - Hydrocortancyl

• Registration Number: NCT00804531
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Study Start: 2009-04
• Primary Completion: 2015-05
• Study Completion: 2015-11
• Status Verified: 2016-05
• Last Update Submitted: 2017-08-11
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Visipaque	Placebo comparator	Administration of only one treatment in intra discal of visipaque
Visipaque - Hydrocortancyl	Visipaque - Hydrocortancyl	Administration of two treatments for the experimental arm

Primary Outcome Measures

Name	Time	Method
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	1 month

Secondary Outcome Measures

Name	Time	Method
pain level at 12 months	12 months
Disability (Quebec questionnaire)	1 month and 12 months
quality of life (SF-12) at 1 and 12 months	1 month and 12 months
anxiety and depression (HAD)	1 month and 12 months
disc inflammation (on MRI) at 12 month	12 months
analgesics and anti-inflammatories during the last week	1 month and 12 months
return to work	1 month and 12 months
Assessment of the disabilities (scale of 6 classes)	1 month and 12 months

Trial Locations

Locations (1)

Hôpital Cochin; 🇫🇷 Paris, France