Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty
Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty: A Double-Blind, Randomized, Sham-controlled Trial
研究概览
详细说明
Surgeons are continually looking for means to minimize postoperative pain following TKA in order to reduce or eliminate the need for opioid pain medications. Reductions in pain and edema along with improvements in range of motion encourage quicker recovery of joint function and normal activities. Pulsed radio frequency (PRF), a type of electromagnetic field treatment is proven to effectively modulate postoperative pain and edema in plastic surgery. Therefore, PRF has potential as an adjunct therapy for patients recovering from TKA.
The purpose of the current double-blind, randomized, sham-controlled clinical trial is to determine the effectiveness and safety of the Ivivi Torino II, a device that delivers pulsed radio frequency (PRF), a type of electromagnetic field treatment, in patients recovering from TKA for treatment of severe knee OA.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Virginia
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Alexandria、Virginia、美国、22306
- Anderson Orthopaedic Research Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 40 to 80 years
- Primary diagnosis of knee OA
- Appropriate candidate for TKA
- Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
- Consent to the study and willing to comply with study product and methods including follow-up
Exclusion Criteria:
- Body mass index > 40 kg/m2
- Scheduled for bilateral TKA
- Advanced hip, spine, or ankle osteoarthritis that significantly limits ambulation
- Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)
- Use of narcotic pain medication for any condition in the last 1 month prior to surgery
- Self-reported diagnosis of post-traumatic or inflammatory arthritis (e.g. rheumatoid or psoriatic)
- Pregnant or lactating female
- Participation in any clinical trial in the past 30 days
- Vulnerable populations including prisoners and nursing home residents
- Any medical condition that, in the opinion of the investigator, may compromise patient safety or confound the assessment of treatment effectiveness
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
假比较器:假
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Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
其他名称:
Sham treatment for 4 weeks post-surgery
其他名称:
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有源比较器:Targeted pulsed electromagnetic field
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Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
其他名称:
Sham treatment for 4 weeks post-surgery
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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The average daily morphine equivalent dose consumption at 2 weeks post-surgery.
大体时间:2-week follow-up period from surgery
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2-week follow-up period from surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Post-surgical opioid use during hospitalization and following discharge at 1 and 4 weeks post-surgery.
大体时间:1 and 4 weeks post-surgery
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1 and 4 weeks post-surgery
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Knee pain severity assessed on a 10 cm visual analogue scale (VAS)
大体时间:At intervals over the 4-week follow-up period
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Knee pain will be assessed for "current", pain at the time of data collection and "maximum", maximum pain experience at any point during the day of evaluation
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At intervals over the 4-week follow-up period
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The measurement of knee joint circumference
大体时间:Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit
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With patient in supine position, the circumference of the extended knee will be measured 1 cm proximal to the base of the patella using the same type of tape measure in all patients
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Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit
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Range of motion of the knee joint, assessed using the knee flexion technique
大体时间:Assessed preoperatively, on the first or second postoperative day, at the discharge dressing change (unless discharged within 2 days), and at the 4 week follow-up visit
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Range of motion will be assessed using the knee flexion technique, which allows the use of a goniometer with the trans-epicondylar axis of the knee joint as the fulcrum.
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Assessed preoperatively, on the first or second postoperative day, at the discharge dressing change (unless discharged within 2 days), and at the 4 week follow-up visit
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OA-related medication use including analgesics, anti-inflammatories, and other non-opioids
大体时间:4 weeks post-surgery
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Subjects will be required to track daily OA-related medication use including analgesics, anti-inflammatories, and other non-opioids using a daily diary.
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4 weeks post-surgery
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Adverse Events collected and analyzed for confirmation of device safety
大体时间:Randomization to 4 weeks post-surgery
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Subjects will be instructed by the research staff and in the instructions in the daily diary to contact the research staff and/or investigator with any adverse events (AEs).
Adverse events will be recorded daily.
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Randomization to 4 weeks post-surgery
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合作者和调查者
调查人员
- 首席研究员:Gerard A. Engh, M.D.、Anderson Orthopaedic Research Institute
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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骨关节炎,膝盖的临床试验
Ivivi Torino II的临床试验
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Sun Pharmaceutical Industries LimitedMoebius Medical Ltd.; Nordic Bioscience Clinical Development (NBCD)完全的
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Psychiatric Centre RigshospitaletUniversity of Copenhagen; IT University of Copenhagen完全的