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Enrolment stopped on December 01, 2014 since after 3 years, only 13 patients were included (instead of 274) (Date of last visit last patient : October 3, 2013).
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| corticoïd | Experimental | anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with corticoid (125mg in.5 ml) |
|
| physiological solution | Placebo Comparator | anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with physiological solution (20 ml) |
|
| feigning of peridural infiltration | Sham Comparator | feigning of peridural infiltration : anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with placement of empty syringe in peridural. |
|
| no intervention | No Intervention | natural evolution of discal sciatica |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone acetate | Drug | anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with corticoid (125mg in.5 ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| difference between the mean leg pain during the latest 24 hours preceding the infiltration and that preceding the visit S4 | 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". | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| determine whether medical intervention improve status of patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joelle Glemarec, Doctor | CHU of Nantes | Principal Investigator |
| Grégoire CORMIER, Doctor | CHD of La Roche/Yon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitary Hospital | Nantes | Loire Atlantique | 44093 | France |
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| ID | Term |
|---|---|
| C009935 | prednisolone acetate |
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| sham procedure | Drug | feigning of peridural infiltration : anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with placement of empty syringe in peridural. |
|
| comparator : physiological solution | Drug | anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with physiological solution (20 ml) |
|
to determine wheter the improvement by the infiltration of corticoid is present at visit of 7 days after the infiltration and at visits of 3 and 6 months after the 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 |