NCT05202847撤回不适用
Pulsed Radiofrequency Ablation to the Modified Ablation Points for Chronic Knee Pain Due to Osteoarthritis: Preliminary Prospective Randomized Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The rate at which vascular uptake is confirmed when the first contrast agent is given after the needle is positioned at the target point
研究概览
简要总结
The goal of this study was to perform pulsed radiofrequency ablation with a modified target suggested in the cadaver study by Park et al. (The Knee 27 (2020) 1577-1584) on knee osteoarthritis patients, and to evaluate the effect of reducing the frequency of intravascular injection and reducing pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Medical staff performing patient care, including pain management, and investigators who investigate and record observations and evaluations, and participants are kept unaware of group assignments.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic knee pain that does not respond to conservative treatment (physiotherapy, oral analgesic, steroid intra-articular injection, Hyruan injection) for more than 6 months
- •A score of 6 or higher (out of 10) on the target knee's numerical rating scale
- •Knee osteoarthritis 1-4 confirmed in knee X ray within 6 months of study enrollment
排除标准
- •Systemic inflammatory diseases such as rheumatic diseases
- •uncontrolled diabetes
- •malignant tumor
- •If the target knee has a previous surgical history (arthroscopy, arthroscopy, autologous or allograft osteochondral transplantation and autologous cartilage cell transplantation, osteotomy, arthritis surgery)
- •Patients with lidocaine and contrast agent allergy
- •history of nerve block in the target knee within 2 weeks
- •Body mass index over 40 kg/m2
- •bleeding disorder
- •Pregnant/lactating women
- •Inability to understand informed consent and respond to research questionnaires due to cognitive impairment
- •Unable to read consent form (e.g. illiterate, foreigner, etc.)
结局指标
主要结局
The rate at which vascular uptake is confirmed when the first contrast agent is given after the needle is positioned at the target point
时间窗: during the ablation procedure
Whether vascular uptake is confirmed on the x-ray image is a binary response.
次要结局
- numeric rating score(Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation)
- functional status(Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation)
- quality of life(Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation)
- medication(Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation)
研究者
Ji Yeong Kim
Clinical Assistant Professor
Gangnam Severance Hospital
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