GREAT Knee Pain Reduction Trial, Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparison of pain score at rest
研究概览
简要总结
Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and functional status in non-surgical patients with knee osteoarthritis as well as the high prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA. Patients will be randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control group (RFA needles placed in proper location without effective neurotomy).
详细描述
Total knee arthroplasty (TKA) is a common and effective treatment for severe knee osteoarthritis. As the average age of the population increases in developed countries, the number of TKAs performed is projected to increase to 3.48 million procedures per year by 2030, a 673% increase from 2005. Although TKA is widely accepted as an efficacious form of treatment for severe knee osteoarthritis, the incidence of patient dissatisfaction and postoperative pain cannot be ignored. Genicular nerve RFA has been performed in non-surgical patients with chronic knee osteoarthritis with significant post procedure improvement in pain and functional status. This study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical candidate for total knee arthroplasty secondary to osteoarthritis
- •Radiologic tibiofemoral osteoarthritis (Kellgren-Lawrence grade 2-4)
排除标准
- •Worst knee pain score on day of evaluation <4/10
- •Already taking opioids >100 mg/day of morphine equivalent dose
- •Infectious etiology (over RFA insertion site or systemic)
- •Workers compensation
- •History of adverse reaction to local anesthetic or contrast
- •History of intraarticular injection in the last 6 weeks with steroids or hyaluronic acids
- •Prior total knee arthroplasty
- •Prior open knee surgery or ligament reconstruction
- •Prior RFA of knee joint
- •Connective tissue diseases affecting the knee
- •Sciatic pain
- •Pacemaker
- •Pregnancy
- •Severe medical disease
- •Serious neurological disorders
- •Serious psychiatric disorders
- •Suicidal or homicidal ideation
结局指标
主要结局
Comparison of pain score at rest
时间窗: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.
Pain score at rest using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
Comparison of pain score with ambulation
时间窗: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.
Pain score with ambulation using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
次要结局
- Comparison of PROMIS physical function score(On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52)
- Assessment of pain catastrophizing using Catastrophizing General Chronic Pain (CAT) Scale(Day of genicular RFA or sham procedure)
- Comparison of quadriceps strength(Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively)
- Comparison of Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR)(On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52)
- Comparison of Mobility using Timed Up and Go Test (TUG)(Day of genicular RFA or sham procedure, and postoperative day 1)
- Comparison of PROMIS global health score(On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52)
- Comparison of 7-point Patient Global Impression of Change (PGIC)(Preoperatively on the day of surgery, and at week 2, 6, 24, and 52)
- Comparison of Total opioid use in morphine equivalents(Day of genicular RFA or sham procedure, day of surgery, post op dy 1 and 2, and at weeks 2,6 postoperatively)
- Comparison of Depression assessment using Center for Epidemiologic Studies Depression Scale (CES-D)(Day of genicular RFA or sham procedure and at 6 weeks postoperatively)
- Assessment of pain location using Michigan Body Map(Day of genicular nerve RFA)
- Comparison Range of Motion - Knee(Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively)
研究者
Puneet Mishra
Assistant Professor of Anesthesiology and Pain Medicine, BH Robbins Scholar
Vanderbilt University Medical Center