NCT00804531

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

6.1 years

First QC Date

December 8, 2008

Last Update Submit

September 5, 2025

Conditions

Back Pain Lower Back Chronic

Keywords

Low back painsteroid injectioninter-vertebral discrandomized trialLack of efficacy of usual recommended treatmentsMore than 40 on the pain numeric scale (0-100)Inflammatory discopathy (MODIC I) on MRI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Visipaque - Hydrocortancyl

EXPERIMENTAL

Administration of two treatments for the experimental arm

Drug: Visipaque - Hydrocortancyl

Visipaque

PLACEBO COMPARATOR

Administration of only one treatment in intra discal of visipaque

Drug: Placebo comparator

Interventions

Visipaque - HydrocortancylDRUG

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

Visipaque - Hydrocortancyl
Placebo comparatorDRUG

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

Visipaque

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

Location

Related Publications (2)

  • Nguyen C, Boutron I, Baron G, Sanchez K, Palazzo C, Benchimol R, Paris G, James-Belin E, Lefevre-Colau MM, Beaudreuil J, Laredo JD, Bera-Louville A, Cotten A, Drape JL, Feydy A, Ravaud P, Rannou F, Poiraudeau S. Intradiscal Glucocorticoid Injection for Patients With Chronic Low Back Pain Associated With Active Discopathy: A Randomized Trial. Ann Intern Med. 2017 Apr 18;166(8):547-556. doi: 10.7326/M16-1700. Epub 2017 Mar 21.

    PMID: 28319997BACKGROUND

  • Daste C, Abdoul H, Foissac F, Lefevre-Colau MM, Poiraudeau S, Rannou F, Nguyen C. Patient acceptable symptom state for patient-reported outcomes in people with non-specific chronic low back pain. Ann Phys Rehabil Med. 2022 Jan;65(1):101451. doi: 10.1016/j.rehab.2020.10.005. Epub 2020 Nov 26.

    PMID: 33152522DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Serge Poiraudeau, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2008

First Posted

December 9, 2008

Study Start

April 1, 2009

Primary Completion

May 1, 2015

Study Completion

November 1, 2015

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

FR(1)