Efficacy of TNF-alpha Inhibition in Sciatica With Post-operative Lumbar Spinal Fibrosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Sciatica pain
研究概览
简要总结
TNF-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis. Inhibiting TNF-alpha could significantly decrease spinal fibrosis after lumbar discectomy.
详细描述
OBJECT:
Failed back surgery syndrome is still a challenging therapeutic problem. Clinical studies have demonstrated a significant association between lumbar spinal fibrosis after lumbar discectomy and the recurrence of radicular pain in 25% of cases. Forceful epidural infiltrations, radiotherapy, therapy with D-penicillamine or surgical procedures have had unfavourable results in terms of pain and cost. Magnetic resonance imaging reveals lumbar spinal fibrosis by a hyposignal in the T1 sequence and a hypersignal in T2 sequence around the spinal tissue. Tumor necrosis factor a (TNF-a) is the main cytokine implicated in the formation of tissue fibrosis. In animal models of fibrosis, TNF-a inhibition has been shown to prevent and treat tissue fibrosis.
HYPOTHESIS:
Inhibiting TNF-a could significantly decrease sciatica pain because of lumbar spinal fibrosis after lumbar discectomy by decreasing spinal fibrosis.
METHODS:
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
- Double (Participant, 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
- •age over 18 years old
- •sciatica post discectomy
- •Pain with VAS > 40 mm and impossibility to have his usual activity
- •Surgical discectomy (less than 2 years and more than 6 months)
- •Painless of more than one month and less than one year after the discectomy
- •MRI with gadolinium injection of less than 6 months and done more than 6 months after the discectomy
- •Presence of spinal fibrosis on MRI (hyposignal in T1 enhanced by gadolinium and hypersignal in T2)
- •failure of epidural injection treatment
- •absence of tuberculosis
- •contraception for woman
- •informed consent
排除标准
- •Chronic psychiatric pathologies not treated
- •Presence of conflict between nerve root and herniated disc or disc fragments or spinal stenosis
- •severe cognitives troubles
- •severe cardiac failure (class III or IV)
- •Tuberculosis (active or latent), severe infections
- •Allergy reactions to the drug studied
- •Difficulties to understand french
- •Patients enrolled in another clinical trial in the past three months
- •pregnancy, breastfeeding or no contraception
研究组 & 干预措施
TNF-alpha blocker
Treatment with TNF-alpha blocker
干预措施: TNF blocker (Drug)
Placebo
Treatment with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Sciatica pain
时间窗: 10 days after treatment
Visual analogue scale of lumbar pain
次要结局
- Functional assessments(At 10, 30, 90, 180 days)