Prospective Randomized Trial Evaluating the Role of Genicular Artery Embolization in Treatment of Persistent Pain in Patients With Severe Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain evaluation post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate the role of genicular artery embolization (GAE) in treating persistent pain in patients with severe knee osteoarthritis who have failed conservative treatment and may be unable to undergo surgical treatment because of significant medical commodities. The main questions it aims to answer are:
Does genicular artery embolization reduce persistent knee pain in patients with severe knee osteoarthritis?
Researchers will compare patients who undergo genicular artery embolization with patients who continue conservative treatment, including NSAIDs, physiotherapy, weight reduction programs, and intra-articular injections, to evaluate differences in pain.
Participants will:
- Undergo assessment of knee pain and function using the Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score before treatment.
- Be randomly assigned to either genicular artery embolization or continued conservative treatment.
- Have pain and functional outcomes assessed before treatment and at 6 weeks, 3 months, and 6 months after the intervention.
详细描述
Randomized control trial were subjects will be chosen through envelop opaque technique, and all subjects will be included according to inclusion and exclusion criteria The intervention of interest is genicular artery embolization and our main outome is assessing pain post procedure The control group will be patients on conservative therapy such as (NSAIDS, physiotherapy, weight reduction programm, Intrarticular injections) This control group will be compared to the other two limbs of the study which are patinet who undergo embolization Assessing pain as primary objective and function as secondary objective will be through used tools such as WOMAC score, VAS, score.
Pain and funtion variables will be collected in the following manner:
- Pre procedure
- Six weeks after the procedure - 3 months after the procedure - 6 months after the procedure
The data will be entered to Microsoft Excel and then be analyzed on Statistical Package for the Social Sciences (SPSS) version 22.
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
- 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
- •Adults aged 18 years or older of either sex. Diagnosis of knee osteoarthritis with a Kellgren-Lawrence grade of 3 or higher. Persistent knee pain resistant to conservative treatment for at least 3 months. Conservative treatment includes NSAIDs, physiotherapy, weight reduction programs, and intra-articular injections.
- •Patients with multiple comorbidities who are indicated for operative treatment, such as total knee arthroplasty, for pain management but are unable to undergo surgery due to their medical status.
排除标准
- •Previous knee arthroplasty in the affected knee. Known malignancy. Local infection. Rheumatoid arthritis. Intra-articular injection in the affected knee within the previous 6 months. Body weight greater than 150 kg. Renal impairment. Irreversible coagulopathy. Peripheral vascular disease.
- •Study Population:
- •Patients will be recruited from King Abdulaziz Medical City, National Guard Hospital, Jeddah, Saudi Arabia.
研究组 & 干预措施
Control arm of conservative management
干预措施: Conservative treatment (Other)
Intervention Arm of genicular artery embolization
干预措施: embolization therapy (Procedure)
结局指标
主要结局
Pain evaluation post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: from enrollment until 6 months after the procedure is done
To evaluate the role of genicular artery embolization in treatment of persistent pain using Western Ontario and McMaster Universities Osteoarthritis Index in patients with severe knee osteoarthritis. For the Western Ontario and McMaster Universities Osteoarthritis Index score it includes 3 parameters which are pain, stiffness, and physical function and scored from 0 to 4 having 0 as None and 4 as the most extreme for each variable, and for the total score having 0 is the best response and 96 is the worst.
Pain evaluation post Genicular artery embolization using Visual Analogue Scale
时间窗: from enrollment until 6 months after the procedure is done
To evaluate the role of genicular artery embolization in treatment of persistent pain using Visual Analogue Scale in patients with severe knee osteoarthritis. For Visual Analogue Scale score it is used to assess the pain only from 0 to 10 having 0 is None and 10 is the most Extreme
次要结局
- Functional status post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index(from enrollment until 6 months after the procedure is done)