refractory lumbosciatic patients MedDRA version: 21.1 Level: LLT Classification code 10024251 Term: Lesion of sciatic nerve System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Dexaméthasone
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Infiltration
Sponsors
CHU de Nantes
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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;Primary end point(s): The primary endpoint will be a classical global algo-functional index, OSWESTRY, assessed at 3 weeks (difference D0 / S3).;Timepoint(s) of evaluation of this end point: Week 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: Week 1, 3, 6 12 and 24 | — |
Countries
France
Contacts
Public ContactDirection recherche, CHU de Nantes
CHU de Nantes
Outcome results
None listed