Intra-discal Steroid Injection for MODIC I Discopathy (PREDID)
Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial
To assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on magnetic resonance imaging.
Hypothesis: delivering anti-inflammatory drugs in situ may decrease back pain in patients with inflammatory discopathy
研究概览
详细说明
Objective: to assess the efficacy on pain level of a steroid injection in the inter-vertebral disc for patients with chronic back pain and MODIC I discopathy on MRI
Methods: a multicenter double blind randomized control trial Setting: 3 tertiary care hospitals in France Patients: 134 patients with disabling chronic low back pain not relieved by usual recommended treatments and MODIC I (inflammatory) discopathy on MRI Intervention: Injection of 25 mg of methylprednisolone in the inter-vertebral disc during a discography (intervention group, 67 patients) or discography alone (control group, 67 patients) Outcome measures: The primary outcome measure is pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month. Secondary outcome measures are pain level at 12 months, Disability (Quebec questionnaire), quality of life (SF-12) at 1 and 12 months, anxiety and depression (HAD), analgesics and anti-inflammatories during the last week, return to work, assessment of the disabilities at 1 and 12 months and disc inflammation (on MRI) at 12 months. Tolerance and adverse effects will be recorded.
Trial duration: 36 months(24 months for inclusion and 12 months follow-up) Follow-up visits: at 1, 3, 6, and 12 months Statistical analysis: intention to treat
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Paris、法国、75014
- Hôpital Cochin
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria :
- More than 18 and less than 70 years old
- Low back pain
- Daily pain for at least 3 months
- Pain level during the last 48 hours > 40 on the numeric pain scale (0-100)
- Lack of efficacy of usual recommended treatments and of other spine steroid injections (epidural or facet joints injections)
- Modic I discopathy on MRI
- Intra-discal injection at least 6 months before inclusion
- Written informed consent
- Social security
- Medical examination
Non inclusion criteria :
- Pregnancy
- Hypersensitivity to methylprednisolone or contrast
- Local or general infection
- Previous disc surgery less than 6 months
- Steroid treatment
- Previous infectious spondylodiscitis
- Ankylosing spondylitis
- Sciatica with neurologic defects
- Uncontrolled psychiatric conditions
- Inability to read or understand French language
- Anti-vitamin K treatments
- Severe coagulation diseases
- Fever > 38 or sedimentation rate > 20
- Discopathy with MODIC 1 signal on several different lumbar stages
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Visipaque - Hydrocortancyl
Administration of two treatments for the experimental arm
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Visipaque 320 mg I/ml - 1 ml intra-discal route Hydrocortancyl 25 mg/ml - 1 ml intra-discal route
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安慰剂比较：Visipaque
Administration of only one treatment in intra discal of visipaque
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Visipaque - 320 mg I/ml - 1 ml in intra-discal route
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Back pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month
大体时间：1 month
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1 month
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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pain level at 12 months
大体时间：12 months
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12 months
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Disability (Quebec questionnaire)
大体时间：1 month and 12 months
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1 month and 12 months
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quality of life (SF-12) at 1 and 12 months
大体时间：1 month and 12 months
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1 month and 12 months
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anxiety and depression (HAD)
大体时间：1 month and 12 months
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1 month and 12 months
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disc inflammation (on MRI) at 12 month
大体时间：12 months
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12 months
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analgesics and anti-inflammatories during the last week
大体时间：1 month and 12 months
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1 month and 12 months
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return to work
大体时间：1 month and 12 months
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1 month and 12 months
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Assessment of the disabilities (scale of 6 classes)
大体时间：1 month and 12 months
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1 month and 12 months
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合作者和调查者
调查人员
- 首席研究员：Serge Poiraudeau, MD, PhD、Assistance Publique - Hôpitaux de Paris
出版物和有用的链接
一般刊物
- Nguyen C, Boutron I, Baron G, Sanchez K, Palazzo C, Benchimol R, Paris G, James-Belin E, Lefevre-Colau MM, Beaudreuil J, Laredo JD, Bera-Louville A, Cotten A, Drape JL, Feydy A, Ravaud P, Rannou F, Poiraudeau S. Intradiscal Glucocorticoid Injection for Patients With Chronic Low Back Pain Associated With Active Discopathy: A Randomized Trial. Ann Intern Med. 2017 Apr 18;166(8):547-556. doi: 10.7326/M16-1700. Epub 2017 Mar 21.
- Daste C, Abdoul H, Foissac F, Lefevre-Colau MM, Poiraudeau S, Rannou F, Nguyen C. Patient acceptable symptom state for patient-reported outcomes in people with non-specific chronic low back pain. Ann Phys Rehabil Med. 2022 Jan;65(1):101451. doi: 10.1016/j.rehab.2020.10.005. Epub 2020 Nov 26.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- P070157
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背痛 下背部慢性的临床试验
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Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)完全的
Visipaque - Hydrocortancyl的临床试验
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GE Healthcare完全的冠状动脉疾病 | ST段抬高型心肌梗死中国, 大韩民国