Cutibacterium Acnes Colonization on Intervertebral Discs of Patients With Low Back Pain: Protocol for an Analytical Study With Microbiological, Phenotypic, Genotypic and Multiomics Techniques
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Incidence of C. acnes on intervertebral disc
研究概览
简要总结
The study aims to identify metabolites present in intervertebral discs colonized by C. acnes from patients with low back pain and degenerative disc disease, correlating them with their clinical, radiological and demographic profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Neither the patient nor the surgeons will have access to the results of microbiological cultures or molecular analysis. The radiologist who will review the exams will also be blinded to patient data and laboratory results. The researcher who will analyze the pain and function scores will also be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •low back pain lasting longer than 3 months;
- •MRI findings of degenerative lumbar discopathy (DDL) performed less than 6 months after inclusion in the study;
- •indication for open surgical treatment, with isolated microdiscectomy or associated with lumbar arthrodesis;
- •failure of conservative treatment for at least 6 weeks and/or progressive neurological deficit
排除标准
- •History of open lumbar spine surgery at any stage of life;
- •presence of chemotherapy or pulse therapy with corticoids;
- •patients with immune deficiency;
- •patients undergoing previous intradiscal therapies (nucleotomy or discography);
- •patients undergoing previous endoscopic surgery;
- •patients with a history of previous spinal infection treated with antibiotics in the 6 months prior to inclusion in the study;
- •use of antibiotics in the 2 months prior to the surgical procedure
结局指标
主要结局
Incidence of C. acnes on intervertebral disc
时间窗: Up to 5 months
Incidence of C. acnes on intervertebral disc in patients with chronic low back pain and DDL.
次要结局
未报告次要终点
研究者
Vinicius Magno da Rocha
Clinical Professor
Gaffree & Guinle Universitary Hospital