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临床试验/CTRI/2025/08/092943
CTRI/2025/08/092943尚未招募2/3 期

Comparative study to assess the analgesic efficacy of Cooled Radio Frequency Ablation of genicular nerve and Intra Articular CorticoSteroids, under ultrasound guidance for chronic knee pain from Osteoarthritis knee.

ESI medical college and hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To compare analgesic efficacy of cooled RFA of genicular nerve and Intra articular cortico steroids under ultrasound guidance for chronic knee pain in OA knee

研究概览

简要总结

Osteoarthritis (OA) is one of the most common degenerative disorders among the elderly population. Around 23.46 million individuals in India had OA in 1990; this increased to 62.35 million in 2019. DALY (Disability Adjusted Life Years) due to OA increased from 0.79 million to 2.12 million. OA was the 20th most common cause of YLDs ( Years Lived in Disability) in India in 2019, accounting for 1.48%  of all YLDs; increasing from 23rd most common cause in 1990 . Knee OA was the most common form of OA, followed by hand OA. The prevalence, incidence, and DALYs for OA and knee OA were consistently higher in females than male [1].

 The current treatment of OA knee consists of conservative management such as exercise, physical therapy, pharmacological agents such as NSAIDS. Intake of analgesics to alleviate pain will cause renal damage, gastritis, peptic ulcers etc. When the conservative management fails to relieve pain, non surgical procedures like Intra Articular Injection of Cortico Steroids[2], Hyaluronic Acid [3][4], Platelet Rich Plasma [5] is widely used.The definitive treatment for OA knee is total Knee replacement surgery.

   Intra Articular CorticoSteroids is one of the most commonly used minimally invasive OPD ( Out Patient Department) procedure where a corticosteroid drug is injected into intra articular space to alleviate pain. IACS decreases joint inflammation there by decreasing the pain for a short duration ( wks to months).           The radio frequency ablation is a new treatment methadology for chronic degenerative knee pain. The goal of cooled radio frequency ablation (CRFA) of genicular nerve is to alleviate the knee pain and improve the function and the quality of life of patients with OA knee. It is also a OPD procedure , done without any incision, recovery time is short and the patient can get back soon to their normal day to day activities. Under ultrasound guidance, RF needles will be inserted near the targeted nerves and a gentle electric current  ( cooled)  is passed through it to ablate the nerve. Cooled RFA is better than conventional RFA, as it targets a wider region and chance of ablating the nerve is high. As per previously published articles, the pain relief after RFA procedure may last for 6 month to 1 years duration. Nerves start to regenerate after 6 months and the procedure will provide control over pain long enough for rehabilitation.

 Both the procedures are well tolerated in office setting under local anaesthesia or done in operating room under conscious sedation using a low dose sedative such as midazolam for anxious patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
50.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with ACOR criteria with radiological evidence but not willing for surgery.

排除标准

  • Patient refusal, bleeding diathesis, previous Intra articular injection in last 3 months, previous knee surgeries, rheumatoid arthritis, ligament injuries.

结局指标

主要结局

To compare analgesic efficacy of cooled RFA of genicular nerve and Intra articular cortico steroids under ultrasound guidance for chronic knee pain in OA knee

时间窗: Time point of pain assessment pre procedure, immediately after procedure, 24 hrs, 1 week, 2 week and 4 week interval

次要结局

  • To assess improvement of knee function(Assessed using WOMAC score)

研究者

发起方
ESI medical college and hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

V Vaishnavi

Department of Anaesthesiology

研究点 (1)

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