Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain : a Interventional, Prospective, Multi-center, Open-label Study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- the mean change in pain intensity assessed by a verbal local rating scale (pain intensity numerical scale) between the pre-treatment measurement (inclusion visi) and the post-treatment measurement (Visit 2 at the 3 months)
研究概览
简要总结
The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.
详细描述
After being informed about the study and potential tisks, all patients giving written informed consent will undergo a inclusion visit (CT scan and X ray at least) for study entry. At Day 0, operation with Intradiscal Gelified Ethanol will be performed by the investigator. Follow visit will be performed at 3 months and 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 18 years or older;
- •Pain refractory to conservative treatments for more than 2 months, non-surgical patients
- •Cervicobrachialgia due to disc herniation
- •Chronic discogenic pain (1 or 2 cervical discs) with concordant MRI;
- •Patient agreeing to participate in the study and having given written consent;
- •Patient enrolled in a health insurance plan.
排除标准
- •Prior surgical treatment of the disc(s) studied;
- •Sick leave of more than 12 months secondary to painful symptoms;
- •Patient with Modic 1 score or more
- •History of cognitive-behavioral disorders that could affect the completion of self-questionnaires;
- •Local or systemic infection, or suspicion of infection;
- •Severe coagulation disorders;
- •Other inflammatory rheumatic disease;
- •Severe underlying pathology with life expectancy <1 year;
- •Women of childbearing age who are pregnant at the inclusion visit or who wish to become pregnant before the administration of the treatment (V0);
- •Known allergy to contrast material and/or local anesthetic substances;
- •Patients who cannot read or write Italian;
- •Major person benefiting from a legal protection regime (guardianship, curatorship, safeguard of justice);
结局指标
主要结局
the mean change in pain intensity assessed by a verbal local rating scale (pain intensity numerical scale) between the pre-treatment measurement (inclusion visi) and the post-treatment measurement (Visit 2 at the 3 months)
时间窗: 3 months
In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
次要结局
- Change in pain cervical intensity using the verbal local rating scale [(12 months)
- Change of consumption of painkillers(12 months)
- Change in ability to manage everyday-life activity (Neck Disability Index (NDI) scale) [Time Frame : inclusion, 3 and 12 months after treatment].(12 months)
- Incidence of complication and adverse event rates(12 months)
- Subjective evaluation MacNab(12 months after treatment)