Corticosteroids and discopathies

Phase 1

• Conditions: chronic low back pain; Therapeutic area: Body processes [G] - Physical Phenomena [G01]

• Registration Number: EUCTR2011-005488-25-FR
• Lead Sponsor: H Montpellier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-14
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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