Efficacy of Ultrasound vs Fluoroscopy Guided Genicular Nerve Radiofrequency Ablation for Chronic Knee Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- Effectiveness of Block
研究概览
简要总结
The goal of this prospective randomized control trial is to provide continued pain relief, classically long-lasting 3 to12 months, and enhanced function in patients following: both gender; male and female, age group; >50yr, healthy volunteers along with Radiographic diagnosis of knee OA with KL grade 3 and 4 in addition of Chronic knee pain ≥ 6 months and patients with ≥50% decrease in pain strength after diagnostic genicular nerve block. The main question it aims to answer is:
Is ultrasound-guided genicular nerve RFA more efficient in lowering pain intensity at six months contrasted with fluoroscopic guided method in patients with chronic knee osteoarthritis? Researchers will compare Group A (Fluoroscopic) to Group B (Ultrasound) to see comparison in efficiency of ultrasound guided against fluoroscopic guided genicular nerves block for decrease in pain intensity and functional improvement.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both gender patients of age more than 50 years.
- •Radiographic diagnosis of knee OA with KL level 3 and
- •Chronic knee pain for more than 6 months
- •Patients with more than 50% reduction in pain intensity after diagnostic genicular nerve block
排除标准
- •Lack of consent
- •surgery of knee
- •Patient with BMI more than 40kg/m2
- •Intra-articular steroid injection or hyaluronic acid in last 3 months
- •Localized infection at procedure site or knee.
- •Patient unable to communicate properly (Severe psychiatric illness, severe dementia and cognitive impairment).
- •Patients have moderate to severe low back pain (NRS ≥5)
研究组 & 干预措施
Group B
Intervention group in which genicular nerves radiofrequency ablation will be done with the help ultrasound guidance.
干预措施: Ultrasound Guided (Procedure)
Group A
Control group in which genicular nerves radiofrequency ablation will be done with the help of fluoroscopic guidance.
干预措施: Fluoroscope Guided (Procedure)
结局指标
主要结局
Effectiveness of Block
时间窗: Post procedure 2 weeks, then follow up after 2, 4 and 6 months.
Block will be considered effective if decrease in pain score from baseline is \>50% at six months. And this will measure by using the 11-point Numeric Rating Scale (NRS) where 0 = no pain and 10 = worst imaginable pain.
次要结局
- Functional Improvement after block(6 months)
研究者
Ali Sarfraz Siddiqui
Associate Professor
Aga Khan University