Radiofrequency For The Treatment Of Chronic Knee Pain Following Total Knee Arthroplasty: A Double-Blind Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Mean difference in knee pain intensities as indicated on the Visual Analog Scale
研究概览
简要总结
Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.
The purpose of this study is to evaluate whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain.
详细描述
Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.
As the prevalence of knee arthroplasty increases, so does the frequency of revisions. It has been found that 20% of patients reporting painful knee arthroplasties were not able to be diagnosed with a specific cause and were therefore referred to a pain specialist. Pharmacologic therapy and non-surgical interventions are often employed with minimal benefit to the patient's level of disability as indicated by clinical evidence.
Genicular radiofrequency ablation seems to be a safe, effective and minimally invasive therapy for chronic knee OA patients who have had a positive diagnostic block. No study has determined whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain. The investigators propose to examine the effect of genicular radiofrequency ablation in chronic post-arthroplasty knee pain in patients who respond positively to diagnostic nerve blocks.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study candidate must provide written informed consent.
- •Must be ≥ 50 years of age at the time of consent
- •Chronic knee pain despite total knee arthroplasty at least 6 months prior to consent
- •Orthopedic evaluation indicating no further surgery is warranted
- •Stable pain medication regimen for 30 days prior to baseline visit
- •Knee pain is primary pain complaint
排除标准
- •Acute knee pain
- •Connective tissue disorders affecting the knee
- •Serious neurologic or psychiatric disorders that would affect the outcome of the study as determined by the Principal Investigator
- •Steroid or hyaluronic acid injections into the affected knee in the past 3 months
- •Confounding pain conditions of the index leg that may affect medication requirements or study outcomes
结局指标
主要结局
Mean difference in knee pain intensities as indicated on the Visual Analog Scale
时间窗: Baseline and 6 weeks post-radiofrequency ablation
次要结局
- Change in Visual Analog Score of average knee pain(Baseline to 1 week, 6 weeks, and 12 weeks)
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline to 1 week, 6 weeks, and 12 weeks)
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline to 1 week, 6 weeks, and 12 weeks)
- Change of Patient Global Assessment(Baseline to 1 week, 6 weeks, and 12 weeks)
- Satisfaction with Radiofrequency Procedure(Baseline to 1 week, 6 weeks, and 12 weeks)
- Rate of procedure-related Adverse Events(From informed consent through study completion, up to 20 weeks)
- Rate of Serious Adverse Events(From informed consent through study completion, up to 20 weeks)
研究者
Randall Brewer, MD, CPI
Medical Director, Principal Investigator
Willis-Knighton River Cities Clinical Research Center