Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
研究概览
简要总结
To compare the effects of the following types of therapy on knee range of motion when given to patients with chronic knee pain:
- A standard steroid injection
- Peripheral nerve stimulation (PNS) therapy in combination with a standard steroid injection
- PNS therapy in combination with a placebo injection
Steroid injections are given directly into the knee joints and are considered to be the standard therapy for chronic knee pain. In this study, the injection will be made of the steroid drugs triamcinolone and bupivacaine.
详细描述
Primary Objectives:
- To compare the mean change in knee range of motion using goniometry from at 30 days (visit 2) from baseline among the three treatment arms.
Secondary Objectives:
- To compare the mean change in knee range of motion using goniometry at 60 days (visit 3) and 90 days (visit 4) from baseline among the three treatment arms.
- To compare changes in knee pain scores (NRS), WOMAC index, use of opioids (measured in morphine milliequivalent), and incidence of complications and adverse effects at 30 days, 60 days, and 90 days from baseline among the three treatment arms
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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
- Patients diagnosed with chronic knee pain (baseline pain score >=4), seen at Pain Management Center at MD Anderson Cancer Center; if patient has bilateral knee pain, the side with the more severe knee pain will be treated first and counted towards the primary and secondary endpoints
- Patients between ages 18-85 years old
- Patient signed informed consent
排除标准
- Patients with cognitive dysfunction or without capacity to consent
- Patient with recent history (<6 months) of drug or alcohol abuse
- Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection
- Patients with allergies to local anesthesia, steroids, or adhesives
- Patients who are on opioids for reasons other than knee pain
研究组 & 干预措施
Group 2 (PNS therapy plus 1 standard steroid injection).
Participants will receive PNS therapy plus 1 standard steroid injection.
干预措施: PNS therapy (Other)
Group 3 (PNS therapy plus 1 placebo injection)
Participants will receive PNS therapy plus 1 placebo injection.
干预措施: PNS therapy (Other)
Group 3 (PNS therapy plus 1 placebo injection)
Participants will receive PNS therapy plus 1 placebo injection.
干预措施: Placebo (Other)
Group 1 (standard steroid injection)
Participants will receive 1 standard steroid injection.
干预措施: Triamcinolone (Drug)
Group 1 (standard steroid injection)
Participants will receive 1 standard steroid injection.
干预措施: Bupivacaine (Drug)
Group 2 (PNS therapy plus 1 standard steroid injection).
Participants will receive PNS therapy plus 1 standard steroid injection.
干预措施: Triamcinolone (Drug)
Group 2 (PNS therapy plus 1 standard steroid injection).
Participants will receive PNS therapy plus 1 standard steroid injection.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
时间窗: through study completion; an average of 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
标识符
- NCT 编号
- NCT06004882
- 其他研究编号
- 2023-0041, NCI-2023-06513
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (4个月后)
- 研究完成日期
- (4个月后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否