Sequential Genicular Nerve Ablation Prior to Geniculate Artery Embolization in Knee Pain Management: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Reduction in Knee Pain
研究概览
简要总结
The goal of this clinical trial is to evaluate whether performing genicular nerve ablation (GNA) before geniculate artery embolization (GAE) improves pain relief and knee function in patients with chronic knee pain. The main questions it aims to answer are:
- Does performing GNA prior to GAE enhance pain relief, as measured by the Visual Analog Scale (VAS), at 3 months post-procedure?
- Does the sequential approach improve knee function as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)?
Study investigators will compare two groups to see if the sequential approach (GNA followed by GAE) provides better outcomes compared to GAE alone.
Participants will:
- Undergo either sequential GNA followed by GAE or GAE alone
- Have their knee pain and function assessed at baseline, 1 month, 3 months, and 6 months post-procedure
- Complete a structured patient satisfaction questionnaire (PSQ) at 3 months post-procedure
- Be monitored for procedure-related adverse events up to 6 months post-procedure,
详细描述
Background:
Chronic knee pain is a prevalent condition affecting a significant portion of the population, often leading to reduced quality of life and functional impairment. Current treatment options include genicular nerve ablation (GNA) and geniculate artery embolization (GAE). However, the optimal sequence of these interventions remains unclear.
Rationale:
The rationale for investigating the sequence of genicular nerve ablation (GNA) followed by geniculate artery embolization (GAE) lies in potentially optimizing pain relief and functional outcomes while ensuring patient safety and satisfaction. GNA aims to interrupt pain transmission from the genicular nerves to the central nervous system, while GAE targets the blood supply to the inflamed synovium, reducing inflammation and pain. Understanding whether performing GNA prior to GAE offers superior pain relief, functional improvement, and patient satisfaction compared to GAE alone is crucial for optimizing treatment protocols and guiding clinical practice.
Objectives:
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
- Single (Outcomes Assessor)
盲法说明
Given the specific nature of the interventions, it may not be possible to blind participants or operators; however, to minimize potential bias, outcome assessors will be blinded to the treatment assignments.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 80 years.
- •Diagnosed with chronic knee pain refractory to conservative treatment.
- •Able to provide informed consent.
- •Agree to follow the study procedures and attend follow-up visits.
排除标准
- •Contraindications to GNA or GAE procedures (e.g., allergy to local anesthetics, active infection at the procedure site).
- •Recent knee surgery within the last six months.
- •Severe comorbid conditions that may interfere with the study outcomes (e.g., rheumatoid arthritis, other severe autoimmune diseases).
- •Current participation in another clinical trial that could interfere with the outcomes of this study.
结局指标
主要结局
Reduction in Knee Pain
时间窗: 3 months post-procedure
This outcome measures the change in knee pain as reported by participants using the Visual Analog Scale (VAS). A lower score indicates less pain, signifying an improvement.
次要结局
- Incidence of Procedure-Related Adverse Events(From the time of procedure up to 6 months)
- Patient Satisfaction with the Procedure(3 months post-procedure)
- Improvement in Knee Function(Assessed at 1 month, 3 months, and 6 months post-procedure)
研究者
Ahmed Awad Bessar
Assistant Professor of Diagnostic and Interventional Radiology
Zagazig University