Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 230
- 试验地点
- 5
- 主要终点
- Short-term efficacy profile
研究概览
简要总结
DISCOGEL® is on the market since 2007. About 20,000 kits were sold to date (October 2017). The device re-obtained its CE mark in 2017.
A clinical evaluation was performed by bibliographic route in 2016. Clinical data on more than 600 patients treated by DISCOGEL® were analyzed. These data should be confirmed by monitoring on the long term, with a large cohort of patients, over a two-year follow-up period.
As part of the post-CE surveillance, the manufacturer GELSCOM is responsible of this "Post-Market Clinical Follow-up" (PMCF) study in accordance with Directive 93/42/EEC and MEDDEV guide 2.12/2, to assess the efficacy and the long-term safety of DISCOGEL®.
The study is comparative. The results will evaluate the performance and safety of the CE-marked medical device used in "real life", in comparison with a steroid infiltration, used according to its indication and to the current standards. It will include economic data. Patients and evaluators will be blinded. Both DISCOGEL® and HYDROCORTANCYL 2,5 POUR CENT are authorized products used according to their intended use.
This is an interventional, prospective, national, multi-center, comparative, randomized, single-blind (patient and evaluator) post-market clinical study. The primary objective is to compare the short-term efficacy profile of DISCOGEL® versus intradiscal steroid.
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, Outcomes Assessor)
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
- •Patient 18 years of age or older;
- •2-month refractory pain to conservative treatment, non-surgical patients;
- •Chronic discogenic pain (1 or 2 lumbar discs) with concordant MR imaging;
- •Symptomatic for at least 8 weeks despite appropriate medical treatment;
- •Patient who agrees to participate in the study and who signed the informed consent form;
- •Patient with social protection.
排除标准
- •Previous surgical treatment of the studied disc(s);
- •Patient with pure radicular pain;
- •Sick leave of more than 12 months secondary to the symptoms;
- •Patients who cannot read or write French;
- •History of cognitive-behavioral disorders that could interact with assessment by self-questionnaire;
- •Local or general infection, or suspicion of infection;
- •Severe coagulation disorders;
- •Other rheumatic inflammatory disease;
- •Undercurrent serious pathology with life expectancy < 2 years;
- •Female of childbearing age that are known to be pregnant during inclusion visit or wishing to become pregnant before treatment;
- •Subject who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection
- •Patient participating in another interventional clinical trial or testing an experimental drug within 30 days of inclusion in the study.
研究组 & 干预措施
Ethanol gel
CE-marked medical device used according to its instructions for use: GELSCOM® Single injection in the selected disc(s) of 0.6 to 2.2 ml
干预措施: Ethanol gel (Device)
Steroid infiltration
Authorized drug used according to its summary product characteristics: HYDROCORTANCYL 2,5 POUR CENT Single injection in the selected disc(s) of 0.2 to 2.0 ml
干预措施: Prednisolone acetate (Drug)
结局指标
主要结局
Short-term efficacy profile
时间窗: Month 3
Compare the short-term efficacy profile of DISCOGEL® versus intradiscal steroid: percentage of patients with a pain relief defined by a Low Back Pain (LBP) intensity\<4 cm on a Local Verbal Rating Scale (0 = no pain to 10 = maximum imaginable pain)
次要结局
- Procedures costs(Day 0)
- Procedures durations(Day 0)
- Long-term efficacy profile(Month 24)
- Questionnaire OSWESTRY(Month 24)
- Questionnaire MacNab(Month 24)
- Radiography(Month 24)
- Magnetic Resonance Imaging(Month 3)
- Short-term safety profile(Month 3)
- Long-term safety profile(Month 24)