Sham-controlled Randomized Trial of Intra-articular Pulsed Radiofrequency Neuromodulation Versus Intra-articular Steroids for Painful Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Visual Analogue Scale pain scores
研究概览
简要总结
To compare the efficacy of intra-articular pulsed radiofrequency to intra-articular steroids in patients with moderate-severe painful osteoarthritis of the knee.
详细描述
Patients Adult patients with intractable knee pain for more than 6 months and radiographic evidence of grade II, III or IV knee osteoarthritis. Must not have had a knee injection or other interventional procedure for knee pain within the past 12 weeks. Must be on stable medications for the past 12 weeks and willing to keep medications stable for the first 12 weeks of the study.
Study Design Pilot study will enroll 30 patients randomized 1:1:1.
- Active control - intra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency
- Placebo control - intra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency
- Treatment group - intra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency
Methods Two 18-gauge radiofrequency needle with 10 millimeter active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Pulsed Radiofrequency or sham-Pulsed Radiofrequency treatment will be administered. Subsequently, the injectate will be administered. Dexamethasone is selected as the corticosteroid as it is colorless and will be indistinguishable from the saline used in the Intra-articular Pulsed Radiofrequency and placebo groups.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of giving written informed consent
- •Patients aged 18 years or older
- •Patients with unilateral or bilateral knee pain for at least 3 months
- •Radiographic evidence of knee osteoarthritis
- •Appropriate candidate for steroid injection as determined by the investigator
排除标准
- •Chronic knee pain caused by infection, inflammation, tumors, and fractures
- •A history of acute knee pain, previous knee surgery, connective tissue diseases, progressive neurologic disease or uncontrolled psychiatric disorders
- •The administration of steroids or hyaluronic acids within the last three months
- •Coagulation disorders
- •Local infection at the site of intervention planned
- •Active litigation related to this pain complaint
结局指标
主要结局
Change in Visual Analogue Scale pain scores
时间窗: 1-week, 1-, 3-, 6-, and 12-months
Evaluates the level of pain. Minimum=0 Maximum=10, Larger number indicates worse outcome
次要结局
- Change in Analgesic use(1-week, 1-, 3-, 6-, and 12-months)
- Change in Timed Up and Go Test(1-week, 1-, 3-, 6-, and 12-months)
- Change in Progression to Surgery(1-week, 1-, 3-, 6-, and 12-months)
- Change in Patient-Reported Outcomes Measurement Information System-29 and Western Ontario and McMaster Universities Osteoarthritis (Index)(1-week, 1-, 3-, 6-, and 12-months)