E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
chronic low back pain |
lombalgie chronique |
|
E.1.1.1 | Medical condition in easily understood language |
treatment of chronic low back pain with a corticosteroid |
traitement de la lombalgie chronique par des corticoides |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Physical Phenomena [G01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
evaluate the effectiveness of the pain of intradiscal injection of corticosteroids |
évaluer l'efficacité sur la douleur d'une injection intradiscale de corticoïdes |
|
E.2.2 | Secondary objectives of the trial |
assess the functional disability, the impact professional use of analgesics |
évaluer le handicap fonctionnel, le retentissement professionnel, la consommation d'antalgiques |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient with low back pain for over 6 weeks associated with a disc on MRI Modic I |
Patient présentant une lombalgie commune depuis plus de 6 semaines associée à une discopathie Modic I à l'IRM
|
|
E.4 | Principal 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 |
1. Patient présentant des antécédents de chirurgie lombaire
2. Patient sous traitement anticoagulant ou anti-agrégant, ou ayant un trouble de la coagulation
3. Patient présentant un diabète sucré non équilibré (glycémie > 1.30 g/l)
4. Patient présentant une hypertension artérielle non stabilisée (> 160/95 mmHg)
5. Patient présentant une infection évolutive
6. Patient présentant une allergie à l'iode ou à l'un des composants de l'Hydrocortancyl*, ou à la Xylocaine
7. Porphyrie, hypersensibilité aux anesthésiques locaux
8. Patient présentant des troubles sphinctériens témoignant d'un syndrome de la queue de cheval
9. Etat psychotique non contrôlé par un traitement
10. Femme enceinte ou en âge de procréer sans moyens de contraception efficace
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
changes in pain on visual analogue scale |
évolution de la douleur sur l'échelle visuelle analogique |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
D1, D30, D90 and D180 |
J1, J30, J90 et J180 |
|
E.5.2 | 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 |
o consommation d'antalgiques et d'AINS
o échelle de handicap spécifique de la lombalgie (échelle Dallas et échelle Oswestry)
o qualité de vie (SF36)
o réalisation ou pas d'une intervention chirurgicale
o reprise ou pas d'une activité professionnelle
o recensement des effets secondaires
o recherche d'éventuelles calcifications |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
D1, D30, D90 and D180 |
J1, J30, J90 and J180 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
dernière visite du dernier patient inclus |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |