Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain assessment: VAS
研究概览
简要总结
The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. In this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a Modic I discopathy.
详细描述
This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •Signed Informed consent
- •Low back pain for more than 6 months associated with Modic I discopathy (diagnosed by MRI)
排除标准
- •Past history of lumbar surgery
- •Patient under anticoagulant or antisludge treatment, or with coagulation troubles
- •Patient with unbalanced diabetes mellitus (blood glucose > 1.30 g/l)
- •Patient with unstabilized high blood pressure (> 160/95 mmHg)
- •Patient with evolving infection
- •Patient with iodine allergy or one of the Hydrocortancyl® or Lidocaine components
- •Porphyria, hypersensitivity to local anaesthetic
- •Patient with sphincter troubles showing a cauda equine syndrome
- •Untreated psychotic state
- •Pregnant women or of childbearing age without effective contraception means
- •Impossible 6 months follow-up
- •Participation to another trial
- •Vulnerable persons protected by the law
- •Persons under guardianship
- •Persons unable to express their consent
研究组 & 干预措施
Corticoids
A group of patients will receive an intradiscal injection of Hydrocortancyl.
干预措施: Hydrocortancyl. (Drug)
Local anaesthetic
A group of patients will receive an intradiscal injection of Lidocaine.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Pain assessment: VAS
时间窗: 1 month
The pain will be assessed by the visual analog scale (VAS).
次要结局
- Pain assessment: VAS(1 week, 2 weeks, 3 weeks, 3 months, 6 months)
- Specific low back pain parameters assessment(1 month, 3 months,6 months)
- Employment status(1 month, 3 months,6 months)
- Quality of life assessment: SF-36(1 month, 3 months, 6 months)
- Consumption of analgesics and NSAIDs assessment(1 month, 3 months,6 months)