Prospective Observational Study of the Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU) of the Lumbar Medial Branch.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Verbal Numerical Rate Scale
研究概览
简要总结
High-intensity focused ultrasound (HIFU) is an emerging technology that allows for the targeted thermal ablation of deep tissues in a non-invasive manner, by concentrating acoustic energy on the target nerve, whilst preserving adjacent structures. Recently, open clinical studies have confirmed the feasibility, safety and efficacy of HIFU in patients with lumbar facet syndrome, with clinical response rates similar to those of RFA and no significant complications.
This observational, prospective, non-interventional study aims to evaluate the clinical efficacy of lumbar medial branch ablation using this technique at 1, 3 and 6 months, as well as to assess patient satisfaction with the procedure. Only clinical data from patients undergoing the procedure in routine clinical practice will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Over 18 years of age.
- •Signed informed consent for data collection.
- •Mechanical low back pain with a positive diagnostic block (>30% pain reduction) of the lumbar medial ramus with local anaesthetic.
排除标准
- •Presence of pain with mixed characteristics or suspected multiple aetiology of the low back pain (e.g. sacroiliac joint involvement).
- •Active systemic infection.
- •Pregnancy.
- •History of spinal surgery at the level of treatment.
- •Presence of tumours, metastatic disease or osteoporosis in the treatment area.
- •Pacemaker or implantable generator carriers.
- •Coagulation disorders or thrombocytopenia.
- •Vertebral fracture or compression at the treatment level.
- •Medical condition contraindicating sedation or the treatment position.
研究组 & 干预措施
Pacients with mechanical lumbalgia
Pacients with mechanical lumbalgia
干预措施: High-Intensity Focused Ultrasound of the medial lumbar branch (Procedure)
结局指标
主要结局
Verbal Numerical Rate Scale
时间窗: 1, 3, 6 months
0 - 10 Verbal Numerical Rate Scale
次要结局
- Catastrophisme scale(1, 3, 6 months)
- Brief Pain Inventory(1, 3, 6 months)
- Oswestry Scale(1, 3 and 6 months)
研究者
Carles Espinos Ramírez
Principal Investigator
Consorci Sanitari de Terrassa