Discal Sciatica Clinical Trial
Official title:
Open Randomized Study on the Efficacy of corticoïd Infiltration Versus Physiological Solution Infiltration Versus Feigning of Infiltration Via Sacro-coccygien Hiatus Versus Natural Evolution in Discal Sciatica
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02151045 -
Comparison of a Cortivazol (ALTIM®) Infiltration of Posterior Epidural Space at L3-L4 Stage Versus an Epidural Infiltration of Cortivazol (ALTIM®) on Contact With Disco Radicular Conflict in Discal Sciatica
|
Phase 3 |