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Clinical Trials/EUCTR2011-005488-25-FR
EUCTR2011-005488-25-FR
Active, not recruiting
Phase 1

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

H Montpellier0 sites40 target enrollmentAugust 14, 2012
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Conditionschronic low back painTherapeutic area: Body processes [G] - Physical Phenomena [G01]
DrugsHydrocortancyl 2.5%Lidocaine Aguettant 20 mg/ml without preservative

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
chronic low back pain
Sponsor
H Montpellier
Enrollment
40
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 14, 2012
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
H Montpellier

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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