"Comparison of the Effects of Genicular Radiofrequency Ablation and Pulsed Radiofrequency Applications on Pain Levels in Patients with Osteoarthritis, Guided by Ultrasound''
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Numeric rating scale (NRS) ,
研究概览
简要总结
This study investigates the effectiveness of two treatments-genicular nerve radiofrequency ablation and pulsed radiofrequency-in reducing pain and improving function in osteoarthritis patients. These techniques, used after diagnostic nerve blocks, aim to provide long-lasting pain relief. Despite both being found effective, no clear consensus exists on which method is superior. The study seeks to compare these techniques and contribute new insights to the existing literature.
详细描述
Chronic knee pain, especially in osteoarthritis patients, is a common condition that significantly affects mobility and quality of life. In individuals over the age of 60, the incidence is 9.6% in men and 18% in women. In patients with osteoarthritis, weight loss and appropriate exercises are recommended as the primary treatments. This is followed by medical therapy, injection treatments, and, if necessary, total knee arthroplasty. However, for patients with a body mass index (BMI) of 40 or higher, total knee arthroplasty is avoided due to the high surgical risk. In recent years, genicular nerve diagnostic block and radiofrequency ablation have been shown to reduce pain and improve function in these patients . Radiofrequency ablation works by blocking the transmission of sensory nerves, thereby improving function.
The innervation of the knee joint originates from the femoral nerve's articular branches, the common peroneal, saphenous, tibial, and obturator nerves. These articular branches are known as the genicular nerves, which are superficial and can be easily accessed using both fluoroscopy and ultrasound.
In osteoarthritis patients, superior medial, superior lateral, and inferior medial genicular nerve blocks are applied. After the diagnostic block, some clinics apply radiofrequency thermocoagulation to the genicular nerve branches for a lasting effect, while others use pulsed radiofrequency. Both techniques have been found to be effective, but there is no data in the literature regarding which technique is superior. The aim of this study is to determine which of the two techniques is more effective and share the findings with the literature.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Patient Blinding (Single Blind for Patients):
The patients will not be informed about which treatment group they have been assigned to.
They will only know that they are participating in a clinical trial, but not the specifics of the treatment or control group.
Investigator Blinding (Double Blind for Investigators):
The principal investigator and all clinical staff involved in the treatment administration and assessment of outcomes will also be blinded to the patients' group assignments.
The study medications or interventions will be labeled with codes, and the investigators will not have access to the key linking these codes to the specific treatments.
Randomization:
Random assignment will be used to allocate participants to one of the two groups (treatment group or control group) to ensure unbiased distribution of participants.
Randomization will be performed using a computerized random number generator.
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 the age of 18
- •osteoarthritis
- •Grade 2-4 gonarthrosis according to the Kellgren-Lawrence (KL) classification
- •Pain 6-10 on the Numeric Rating Scale (NRS)
排除标准
- •Patients with chronic knee pain due to another pathology (e.g., meniscopathy, trauma, rheumatoid arthritis) History of previous knee surgery History of intra-articular injection in the last 3 months Coagulopathy, use of antiplatelet or anticoagulant medications Infection Severe psychiatric disorders Patients with a cardiac pacemaker or defibrillator Renal or hepatic failure
结局指标
主要结局
Numeric rating scale (NRS) ,
时间窗: Baseline, 3 weeks, 3 months.
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable
次要结局
- Western Ontario and McMaster (WOMAC) Osteoarthritis Index(Baseline, 3 weeks, 3 months.)
研究者
Ülkü Sabuncu
Assoc. Prof.
Ankara City Hospital Bilkent