Comparison of Denervation Techniques for the Treatment of Knee Osteoarthritis: a Randomized Clinical Trial of Continuous Ablative Radiofrequency Vs. Chemical Denervation with Absolute Alcohol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
研究概览
简要总结
This randomized clinical trial compares two minimally invasive treatments for knee osteoarthritis pain that has not responded to conventional therapies. The study evaluates the effectiveness and safety of continuous ablative radiofrequency, which uses heat energy to disrupt pain signals, and chemical denervation with absolute alcohol, which involves an injection to reduce pain transmission. Participants will be randomly assigned to one of the treatments, and their pain levels, mobility, and quality of life will be monitored over time to determine which method provides better pain relief.
详细描述
This randomized clinical trial compares continuous ablative radiofrequency and chemical denervation with absolute alcohol for pain relief in patients with knee osteoarthritis refractory to conventional treatments. Participants will be randomly assigned to one of the two procedures, with outcomes assessed based on pain reduction, functional improvement, quality of life, and safety. Follow-ups will be conducted for up to six months to evaluate the durability of pain relief, providing evidence to guide clinical management of chronic knee osteoarthritis pain.
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
- Single (Outcomes Assessor)
盲法说明
This study will use single-blind masking, where participants will be unaware of which treatment they receive. The physicians performing the procedures will not be blinded due to the nature of the interventions. However, the outcome assessors and data analysts will be blinded to the treatment allocation to minimize bias in pain assessments, functional evaluations, and overall study results.
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
- •Adults aged ≥ 18 years.
- •Knee pain for more than 3 months.
- •Clinical and imaging-confirmed diagnosis of knee osteoarthritis, based on X-ray, ultrasound, or magnetic resonance imaging (MRI).
排除标准
- •History of major joint interventions, such as previous knee surgery or arthroplasty.
- •Severe joint effusion.
- •Coagulation disorders or other clinical contraindications for the procedure.
- •Uncontrolled comorbidities that increase procedural risk.
- •Body mass index (BMI) >
- •Cognitive impairment that affects the ability to understand and respond to pain assessment instruments.
研究组 & 干预措施
Continuous Ablative Radiofrequency
Participants in this arm will undergo continuous ablative radiofrequency targeting the sensory genicular nerves responsible for knee pain. The procedure involves the percutaneous insertion of a radiofrequency probe near the targeted nerves under imaging guidance. Controlled thermal energy will be applied to create a lesion, disrupting pain signal transmission. The goal is to provide long-lasting pain relief and improve function in patients with knee osteoarthritis.
干预措施: Continuous Ablative Radiofrequency (Procedure)
Chemical Denervation with Absolute Alcohol
Participants in this arm will undergo chemical denervation with absolute alcohol, targeting the sensory genicular nerves responsible for knee pain. The procedure involves the percutaneous injection of absolute alcohol near the selected nerves under imaging guidance. The neurolytic effect of alcohol disrupts pain signal transmission, aiming to provide prolonged pain relief and functional improvement in patients with knee osteoarthritis.
干预措施: Chemical Denervation with Absolute Alcohol (Drug)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
时间窗: 6 months
a validated questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. It consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is rated on a Likert scale (0-4), with higher scores indicating greater pain, stiffness, and functional impairment. The total WOMAC score will be measured at baseline, 1 month, 3 months, and 6 months post-intervention to evaluate the effectiveness of the treatments in improving knee osteoarthritis symptoms.
次要结局
- Numerical Rating Scale (NRS) for Pain(6 months)
- Short Form-36 Health Survey (SF-36)(6 months)
研究者
Leonardo Henrique Cunha Ferraro
Associate Professor, MD, PhD
Federal University of São Paulo