Comparative Effectiveness of Genicular Nerve Radiofrequency Thermocoagulation and Intra-Articular Pulsed Radiofrequency in the Management of Knee Osteoarthritis Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- NRS
研究概览
简要总结
Osteoarthritis (OA) is a degenerative disease characterized by progressive cartilage deterioration, osteophyte formation, subchondral sclerosis, and a number of biochemical and morphological changes in weight-bearing joints that are affected by genetic, mechanical, and biochemical factors. The prevalence of secondary chronic knee pain in OA is more than 12% in individuals over the age of 60. It is one of the most common musculoskeletal disorders in elderly patients and has become a global health problem. Standard treatments for OA include physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol, opioids, intra-articular hyaluronic acid, or steroids. In more severe cases, surgical knee arthroplasty should be considered. But long-term use of NSAIDs is associated with stomach bleeding, adverse cardiovascular events, and kidney failure. Opioids are often used, but a large number of side effects are encountered, especially in the elderly. Knee surgery is not always possible and can cause complications such as hematomas, infections, and damage to the surrounding tissue.
Radiofrequency (RF) application (pulsed or continuous) is a neuromodulatory or neurolytic technique that represents an alternative in pain due to osteoarthritis. RF therapy is one of the conservative treatments that has many advantages, such as minimal invasiveness, rapid recovery, and less negative response. Radiofrequency thermocoagulation (RFT) destroys the integrity of peripheral nerves using hyperthermia and thereby blocks the transmission of pain signals, while pulsed radiofrequency (PRF) regulates neurological functions or inhibits the production of immunoinflammatory factors (e.g., IL-1β, TNF-α, IL-6) by using electric fields to affect their production, thereby relieving pain in patients.
Genicular nerve radiofrequency thermocoagulation application and knee intra-articular pulsed radiofrequency application are the two radiofrequency methods routinely applied in the treatment of gonarthrosis-induced pain in our clinic. In this study, it is aimed to evaluate the effectiveness of these two methods and compare their outcomes.
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
- None
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
- •Patients over 18 years of age;
- •Patients who have pain due to knee osteoarthritis
- •Patients who agree to undergo knee geniculate nerve thermocoagulation or knee intra-articular pulsed radiofrequency therapy and follow-up.
排除标准
- •Patients using anticoagulants and those with coagulation disorders,
- •Patients with psychomotor disorders,
- •Patients who have undergone intra-articular injections, interventional procedures, or surgery for knee osteoarthritis in the last year,
- •Patients with bacterial infection or infectious discharge in the area to be treated,
- •Patients with allergies to local anesthetics, and pregnant and breastfeeding patients
研究组 & 干预措施
GNRFT - Genicular Nerve Radiofrequency Ablation
Patients in this group will undergo ultrasound-guided genicular nerve radiofrequency ablation.
干预措施: GNRFT- genicular nerve radiofrequency ablation (Procedure)
IAPRF - Intra-articular pulsed radiofrequency
KNEE INTRAARTICULAR PULSED RADIOFREQUENCY WILL BE APPLIED TO PATIENTS IN THIS GROUP
干预措施: IAPRF- Intraarticular pulsed radiofrequency (Procedure)
结局指标
主要结局
NRS
时间窗: baseline, at the 3rd month
Pain intensity was measured using an 11-point Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. Patients rated their pain intensity based on their average pain during the defined time frame. Changes in NRS scores over time were used to evaluate treatment response.
次要结局
- GPE(baseline, 3rd month)
- WOMAC(baseline; 3rd month)
研究者
Ali ÇOŞTU
Principal investigator
Ankara City Hospital Bilkent
