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临床试验/CTRI/2025/10/096137
CTRI/2025/10/096137
尚未招募
不适用

Comparison of the efficacy of 3 point versus 5 point genicular nerve radiofrequency ablation in patients with chronic knee osteoarthritis: A randomized control study

lady hardinge medical college1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月26日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To compare the efficacy of 3-point versus 5-point genicular nerve radiofrequency ablation in terms of functional improvement by Oxford Knee Score in patients with chronic knee osteoarthritis at three months post-procedure.

概览

简要总结

Knee osteoarthritis is a prevalent cause of chronic pain and disability, and many patients are unsuitable or unwilling for total knee arthroplasty. Radiofrequency ablation of genicular nerves offers a minimally invasive alternative for pain relief. However, the optimal number of target nerves remains unclear. The conventional 3-point RFA may not capture all pain-transmitting genicular branches, whereas the newer 5-point approach could potentially improve efficacy by addressing additional nerve targets. This study aims to provide high-quality comparative evidence on the functional and analgesic outcomes of both techniques, helping define a more effective and standardized RFA protocol for knee osteoarthritis management.

This randomized controlled study will be conducted at the Department of Anaesthesiology, Lady Hardinge Medical College, New Delhi, from August 2025 to November 2026. Sixty patients aged 40–75 years with chronic knee osteoarthritis (Kellgren-Lawrence grade II–IV) unresponsive to conservative therapy and showing more than 50 percent pain relief after diagnostic genicular nerve block will be enrolled. Participants will be randomly allocated (block randomization) into two groups:

  • Group T: 3-point genicular nerve radiofrequency ablation (RFA)
  • Group F: 5-point genicular nerve RFA

All procedures will be performed under ultrasound guidance using standard monitoring. Each target nerve will be confirmed by sensory and motor stimulation before lesioning at 80°C for 90 seconds. Patients will be followed at 1 week, 1 month, and 3 months post-procedure to assess pain (Numerical Rating Scale) and function (Oxford Knee Score). Data will be analyzed using SPSS v23, with statistical significance set at p less than 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Age group of 40 to 75 years
  • Knee osteoarthritis confirmed by X ray (Kellgren-Lawrence grade 2-4) with pain for at least 3 months and pain intensity of 4 on Numerical Rating Scale (NRS) despite conservative management 3.Patients refusing surgery
  • Positive response to diagnostic genicular nerve block (more than 50 percent pain reduction).

排除标准

  • Previous knee surgery or knee joint replacement or traumatic knee injury
  • Inflammatory arthritis such as rheumatoid arthritis, gout and psoriatic arthritis
  • Patellofemoral osteoarthritis
  • Patients receiving any other invasive treatment for knee osteoarthritis during the study period 5, Prior radiofrequency treatment of the target knee.

结局指标

主要结局

To compare the efficacy of 3-point versus 5-point genicular nerve radiofrequency ablation in terms of functional improvement by Oxford Knee Score in patients with chronic knee osteoarthritis at three months post-procedure.

时间窗: 1 week, 1 month and 3 months, months post-procedure

次要结局

  • Pain reduction by Numerical Rating Scale at 1 week, 1 month, and 3 months post-procedure(2. Procedure-related adverse events and complications)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ganesh S Nath

lady Hardinge Medical college

研究点 (1)

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