Involvement of Transverso-sacral- Neo- Articulations or of Transverso-iliac Articulations in Chronic Lumbago: Prospective Multicentric , Double-Blinded, Randomized of the Efficacy of corticoïd Infiltration Versus Physiological Solution Infiltration
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- To determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)
研究概览
简要总结
The specific aim of this study is to determine whether, when treated with corticoid infiltration, certain chronic lumbagos could be explained by the presence of a neo-articulation.The primary criteria is to determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)
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)
- •Lateralized lumbago on side of the neo-articulation evolving since more than 3 months
- •Mechanical pain, lumbar low level or gluteal without sciatic irradiation (pain above the knee)
- •Mean pain during the latest 24 hours above 4 on an analogic visual scale (from 0 to 10)- 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 clinical proof for a discal origin : inducing factor, impulsiveness, spinal syndrome, true Lasègue
- •transverse-sacral abnormality of IIb, IIIa, IIIc or IV type with neo-articulation lateralized on side of pain
- •Informed consent form signed
排除标准
- •Age below 18
- •Clinical arguments in favour of a discal origin
- •Pregnant women or women that could become pregnant the day of the infiltration
- •Diabetic patient
- •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, suspiscion of infection
- •Severe troubles of coagulation, anti-coagulant treatment taken
- •Bilateral lumbago with bilateral neo-articulation
研究组 & 干预措施
corticoid
Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml)
干预措施: corticoid (altim® 1.5 ml) (Drug)
physiological solution
Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml)
干预措施: physiological solution (1.5 ml) (Drug)
结局指标
主要结局
To determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)
时间窗: week 4
To determine whether, when treated with corticoid infiltration, certain chronic lumbagos could be explained by the presence of a neo-articulation.The primary criteria is to determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)
次要结局
- To determine whether the improvement by the infiltration of corticoid is present at visit J7 (visit 7 days after the infiltration) and at visit S12 (visit 12 weeks after the infiltration)
- To determine whether an anesthetic positif bloc (decrease of the pain of more than 75 % during the hour that follows the infiltration) is a predictive factor of the final result
- To determine whether corticoïd infiltration can decrease the intake of drugs et decrease the functional handicap