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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- difference between the mean leg pain during the latest 24 hours preceding the infiltration and that preceding the visit S4
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult with age equal or above to
- •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
排除标准
- •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
- •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.
研究组 & 干预措施
feigning of peridural infiltration
feigning of peridural infiltration : anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with placement of empty syringe in peridural.
干预措施: sham procedure (Drug)
corticoïd
anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with corticoid (125mg in.5 ml)
干预措施: Prednisolone acetate (Drug)
结局指标
主要结局
difference between the mean leg pain during the latest 24 hours preceding the infiltration and that preceding the visit S4
时间窗: 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".
次要结局
- determine whether medical intervention improve status of patients
- 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 functional handicap