E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
refractory lumbosciatic patients |
patients lombo-sciatalgiques réfractaires
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E.1.1.1 | Medical condition in easily understood language |
persistent lumbosciatic patients |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024251 |
E.1.2 | Term | Lesion of sciatic nerve |
E.1.2 | System Organ Class | 100000004852 |
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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 |
To validate the efficacy of soluble Dexamethasone phosphate, injected through the Sacro-Coccygeal Hiatus, in the improvement of the clinical algofunctional picture of refractory lumbosciatalgic patients |
Valider l’efficacité du phosphate de Dexaméthasone soluble, injecté par la voie du HSC, dans l’amélioration du tableau clinique algofonctionnel de patients lombo-sciatalgiques réfractaires. |
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E.2.2 | Secondary objectives of the trial |
1) Evaluate the effectiveness on lumbar pain 2) Evaluate the effectiveness on sciatic pain 3) Evaluate the functional handicap and the quality of life 4) Evaluate the number of second injections needed 5) Evaluate the number of patients undergoing secondary surgery 6) Evaluate prognostic factors at S3, clinical and imaging 7)Evaluate secondary effects |
1) Evaluer l’efficacité sur la douleur lombaire 2) Evaluer l’efficacité sur la douleur sciatique 3) Evaluer le handicap fonctionnel et la qualité de vie 4) Evaluer le nombre de secondes injections nécessaires 5) Evaluer le nombre de patients opérés secondairement 6) Evaluer les facteurs pronostiques à S3, cliniques et d’imagerie 7) Evaluer les effets secondaires |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with sciatica of disc origin (radio-clinical concordance on MRI or CT) postero-lateral - Duration of evolution greater than 3 weeks despite analgesic / NSAID treatment, and less than 3 months - EVA sciatic pain > 4/10 - Oswestry greater than or equal to 30 at inclusion |
- Patients présentant une sciatique d’origine discale (concordance radio-clinique à l’IRM ou au scanner) postéro-latérale - Durée d’évolution supérieure à 3 semaines malgré un traitement antalgique / AINS, et inférieure à 3 mois - EVA sciatique douleur > 4/10 - Oswestry supérieur ou égal à 30 à l’inclusion
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E.4 | Principal exclusion criteria |
- Signs or risks of infection, in particular signs of viral infection (perform a screening PCR if there is any doubt that it is still a pandemic period when the protocol is set up) - Poor local skin condition - Anticoagulation with VKA or anti-Xa, or haemorrhagic disease (authorised antiaggregants)*. - Neurological deficit < 3/5 or signs of cauda equina irritation - Tarlov's cyst or low dural sac below S4 - Allergy to Lidocaine, Dexamethasone or Sulphites - Spinal infiltration in the previous 3 months - Patient with bilateral sciatica - Patient with sciatica of arthritic origin - Patient with chronic respiratory failure
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- Signes ou risques d’infection, en particulier signe de virose (réalisation d’une PCR de dépistage au moindre doute si l’on est toujours en période pandémique lors de la mise en place du protocole) - Mauvais état cutané local - Anticoagulation par AVK ou antiXa, ou maladie hémorragipare (antiagrégants autorisés)* - Déficit neurologique < 3/5 ou signes d’irritation de la queue de cheval - Kyste de Tarlov ou cul de sac dural bas sous S4 - Allergie à la Lidocaïne, à la Dexaméthasone ou aux Sulfites - Infiltration du rachis dans les 3 mois précédents - Patient présentant une sciatique bilatérale - Patient présentant une sciatique d’origine arthrosique - Patient atteint d’une insuffisance respiratoire chronique
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be a classical global algo-functional index, OSWESTRY, assessed at 3 weeks (difference D0 / S3). |
Le critère d’évaluation principal sera un index global algofonctionnel classique, l’OSWESTRY, évalué à 3 semaines (différence J0 / S3). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) Low back pain VAS assessed at 1 week (S1), 3 weeks (S3), 6 weeks (S6), 12 weeks (M3) and 24 weeks (M6) 2) VAS sciatica pain assessed at 1 week (S1), 3 weeks (S3), 6 weeks (S6), 12 weeks (M3) and 24 weeks (M6) 3) Number of days off work, Oswestry at S1, S6, M3, M6 and SF36 self-questionnaires at S1, S3, S6, M3 and M6 4) Second injection performed within 6 months (yes/no) 5) Secondary surgery performed within 6 months (yes/no) 6) Clinical and imaging parameters for assessment of low back pain 7) VAS pain assessed immediately after the procedure and comprehensive collection of all side effects |
1) EVA douleur lombaire évaluée à 1 semaine (S1), 3 semaines (S3), 6 semaines (S6), 12 semaines (M3) et 24 semaines (M6) 2) EVA douleur sciatique évaluée à 1 semaine (S1), 3 semaines (S3), 6 semaines (S6), 12 semaines (M3) et 24 semaines (M6) 3) Nombre de jours d’arrêt de travail, Oswestry à S1, S6, M3, M6 et auto-questionnaires SF36 à S1, S3, S6, M3 et M6 4) Deuxième injection réalisée dans les 6 mois (oui/non) 5) Chirurgie réalisée secondairement dans les 6 mois (oui/non) 6) Paramètres cliniques et d’imagerie d’évaluation d’une lombosciatique 7) EVA douleur évaluée immédiatement après le geste et recueil exhaustif de tous les effets secondaires |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 1, 3, 6 12 and 24 |
1 ère semaine, 3 semaines, 6 semaines, 12 semaines, 24 semaines |
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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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Assess quality of life and evaluate prognostic factors |
évaluer la qualité de vie et évaluer les facteurs pronostiques |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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
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It's the last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |