Discal Sciatica
Conditions
Keywords
Discal sciatica, infiltrations, Subjects, evolving
Brief summary
The specific aim of this study is to determine whether a medical intervention improve status of patients with discal sciatica and if yes which type of intervention.
Detailed description
The primary criteria is to determine the difference between the mean leg pain during the latest 24 hours preceding the infiltration and the mean leg pain preceding the visit S4 (visit 4 weeks after the infiltration). If difference is of 50% patient will be considered improved. This study will be organized under three steps:Step 1 : when 124 patients will be randomized: first intermediate analysis to compare efficacy of groups 1+ 2+ 3 versus 4. If significant difference is not demonstrated, study will be stopped at this stage since having demonstrating that infiltration or simulation is inefficient. On the other case, step 2 will be performed.Step 2 : Recruitment is continued only in arms 1 to 3 until reaching a total of 142 randomized patients. Second intermediate analysis to compare efficacy of groups 1+ 2 versus 3. If significant difference is not demonstrated, study will be stopped at this stage since having demonstrating that infiltration is inefficient. On the other case, step 3 will be performed.Step 3 : Recruitment is continued only in arms 1 and 2 until reaching a total of 274 randomized patients. Third intermediate analysis to compare efficacy of groups 1 versus 2. Visit of inclusion (J0): 1/ notification in the case report form of - information concerning patient pain (mean, maximal and minimal pain during the 24 last hours)- Oswestry questionnaire - impact of discal sciatica on professional activity,- intake of analgesic, co-analgesics and non steroids anti- inflammatory drugs2/ Randomization and infiltration with corresponding treatment arm3/ Thirty minutes after receiving the infiltration, recording of actual patient pain Visits at day 7, weeks 4, 12 and 24 after J0: Notification in the case report form of - information concerning patient pain (mean, maximal and minimal pain during the 24 last hours)- Oswestry questionnaire - impact of discal sciatica on professional activity,- intake of analgesic, co-analgesics and non steroids anti- inflammatory drugs
Interventions
DRUGPrednisolone acetate
anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with corticoid (125mg in.5 ml)
DRUGsham procedure
feigning of peridural infiltration : anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with placement of empty syringe in peridural.
DRUGcomparator : physiological solution
anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with physiological solution (20 ml)
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult with age equal or above to 18. * Subject affiliated to French health insurance (Sécurité Sociale) * Sciatic pain evolving since more than 1 month and less than 3 months * Leg irradiation (pain above the knee)- True Lasègue- Mean leg pain during the latest 24 hours above 40 on an analogic visual scale (from 0 to 100) * Pain induced by palpation in regards to the neo-articulation * Pain not relieved by medical treatment with non steroids anti- inflammatory drugs or antalgics No sign of seriousness : no motor deficiency (muscular testing above or equal to 4 on an international scale (from 0 to 5), no sphincter deficiency, mean leg pain during the latest 24 hours below 80 on an analogic visual scale (from 0 to 100). * Scanner of MRI since less than 3 months confirming discal hernia L4L5 or L5S1 in accordance with the clinic. * Informed consent form signed
Exclusion criteria
* Age below 18 * Clinical arguments in favour of a non discal origin- Pregnant women * Diabetic patient- Past history of diverticulosis complicated with severe arterial hypertension- Patient unable to understand the protocol * No autonomy for coming to the hospital (no budget allocated for patient transportation) * Hypersensitivity to local anesthetics with liaison amide-Hypersensitivity to one of the components-Porphyria * Local or generalized infection, suspicion of infection * Severe troubles of coagulation, anti-coagulant treatment taken- Imaging non concording * Past history of infiltration via the sacro-coccygien hiatus * Past history of lombar rachis surgery- Body mass index above 40. * Intake of b-bloquants- Intake of antiarrythmics possibly giving torsades de pointe (amiodarone, disopyramide, quinidiniques, sotalol,…)-Cimétidine used at doses above or equal to 800mg/day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference between the mean leg pain during the latest 24 hours preceding the infiltration and that preceding the visit S4 | week 4 | To determine the difference between the mean leg pain during the latest 24 hours preceding the infiltration and the mean leg pain preceding the visit S4 (visit 4 weeks after the infiltration). If difference is of 50% patient will be considered improved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| determine whether medical intervention improve status of patients | — | To determine whether:- injection of physiological solution or of physiological solution +hydrocortancyl is more efficient than simple feigning of peridural infiltration |
| To determine whether intervention can decrease the number of surgeries (follow-up of 6 months) | — | To determine whether intervention can decrease the number of surgeries (follow-up of 6 months) |
| To determine whether intervention can decrease the intake of drugs | — | to determine whether intervention can decrease the intake of drugs |
| To determine whether intervention can decrease the functional handicap | — | To determine whether intervention can decrease the functional handicap |
Countries
France
Outcome results
None listed