Cryoneurolysis Versus Radiofrequency in Knee Osteoarthritis: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in visual analogue scale after intervention
研究概览
简要总结
The project will evaluate the effectiveness of Cryoneurolysis versus radiofrequency procedures in adult patients who are resistant to traditional treatment for knee pain. They are a drug-free pain management procedure.
详细描述
The main approach to OA management is pain control. Cryoneurolysis versus radiofrequency in decreasing knee pain.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
This is a prospective, randomised study. The closed envelop randomization method will be used for the randomization of the patients who will be also blinded to group allocation.
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
- •Adults with a clinical diagnosis of refractory knee OA who suffered from refractory knee pain (patients who had failed conservative medical and physical therapy for 6 months .
排除标准
- •Patients with OA show improvement in pain after conservative medical and physical therapy.
- •Patients evaluated by an orthopedic surgeon and deemed to be surgical candidates due to knee pathologies other than OA.
- •Patients with allergies to local anesthetics.
- •patients on anticoagulation therapy, who were not permitted to stop anticoagulation.
- •Patients with knee tumors.
- •Patients with acute infections.
- •Patients with implanted cardiac devices.
- •Pregnant patients.
研究组 & 干预措施
Group III will be treated with cooled radiofrequency (RF)
uses cooled radiofrequency energy to deactivate pain-causing nerves
干预措施: cooled radiofrequency (Device)
Group I will be treated with Cryoneurolysis
Cryoneurolysis freezes nerves
干预措施: Cryoneurolysis (Device)
Group II will be treated with pulsed radiofrequency (RF)
radiofrequency (RF) uses electric pulses
干预措施: pulsed radiofrequency (RF) (Device)
结局指标
主要结局
Change in visual analogue scale after intervention
时间窗: immediately after intervention
Decrement (clinical improvement) in visual analogue scale (VAS) immediately after intervention. The participant's knee discomfort was measured using a VAS. Participants were asked to score their level of pain on a 100-mm horizontal line, ranging from 0 to 100.
次要结局
未报告次要终点
研究者
Aliaa Mamdouh Abdelaziz Farag
Lecturer
Tanta University