Intra-discal Steroid Injection for MODIC I Discopathy

Back Pain Lower Back Chronic Clinical Trial

— PREDID  

Official title:

Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804531
• Other study ID #: P070157
• Status: Completed
• Phase: Phase 4
• First received: December 8, 2008
• Last updated: August 11, 2017
• Start date: April 2009
• Est. completion date: November 2015

Study information

• Verified date: May 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: November 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Nguyen C, Boutron I, Baron G, Sanchez K, Palazzo C, Benchimol R, Paris G, James-Belin É, Lefèvre-Colau MM, Beaudreuil J, Laredo JD, Béra-Louville A, Cotten A, Drapé JL, Feydy A, Ravaud P, Rannou F, Poiraudeau S. Intradiscal Glucocorticoid Injection for Pa — View Citation

Outcome

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