Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
详细描述
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Visipaque - Hydrocortancyl
Administration of two treatments for the experimental arm
干预措施: Visipaque - Hydrocortancyl (Drug)
Visipaque
Administration of only one treatment in intra discal of visipaque
干预措施: Placebo comparator (Drug)
结局指标
主要结局
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
时间窗: 1 month
次要结局
- Assessment of the disabilities (scale of 6 classes)(1 month and 12 months)
- pain level at 12 months(12 months)
- Disability (Quebec questionnaire)(1 month and 12 months)
- quality of life (SF-12) at 1 and 12 months(1 month and 12 months)
- anxiety and depression (HAD)(1 month and 12 months)
- disc inflammation (on MRI) at 12 month(12 months)
- analgesics and anti-inflammatories during the last week(1 month and 12 months)
- return to work(1 month and 12 months)