Corticosteroids and discopathies

Evaluation of the effectiveness of intradiscal injection of corticosteroids in the Modic I discopathies

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005488-25-FR

Enrollment

Registered

2012-08-14

Start date

2017-02-02

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic low back pain

Interventions

Trade Name: Hydrocortancyl 2.5% Pharmaceutical Form: Suspension for injection Trade Name: Lidocaine Aguettant 20 mg/ml without preservative Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient with low back pain for over 6 weeks associated with a disc on MRI Modic I Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Patient with a history of lumbar surgery 2. Patient on anticoagulant therapy or anti-aggregation, or having a bleeding disorder 3. Patient with unbalanced diabetes mellitus (blood glucose> 1.30 g / l) 4. Patients with hypertension not stabilized (> 160/95 mmHg) 5. Patient with active infection 6. Patient is allergic to iodine or any component of the hydrocortancyl *, or Xylocaine 7. Porphyria, hypersensitivity to local anesthetics 8. Patient with sphincter dysfunction syndrome reflecting the ponytail 9. Psychotic state uncontrolled by treatment 10. Pregnant or of childbearing potential without effective contraception

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluate the effectiveness of the pain of intradiscal injection of corticosteroids;Secondary Objective: assess the functional disability, the impact professional use of analgesics;Primary end point(s): changes in pain on visual analogue scale ;Timepoint(s) of evaluation of this end point: D1, D30, D90 and D180	—

Secondary

Measure	Time frame
Secondary end point(s): o use of analgesics and NSAIDs o scale specific low back pain disability (Oswestry scale and scale Dallas) o quality of life (SF36) o completion or no surgery o return or not an occupation o identification of side effects o find any calcification;Timepoint(s) of evaluation of this end point: D1, D30, D90 and D180	—

Countries

France

Contacts

Public ContactDepartment Research end Innovation

Department Research and Innovation

a-verchere@chu-montpellier.fr0033467330812

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026