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Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty

2012年7月6日 更新者:Amp Orthopedics, Inc.

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

The purpose of this study is to determine the effectiveness of pulsed radio frequency (PRF), a type of electromagnetic field treatment with the Ivivi Torino II for reducing post-operative narcotic use in patients recovering from Total Knee Arthroplasty.

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

介入性

注册 (实际的)

23

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Virginia
      • Alexandria、Virginia、美国、22306
        • Anderson Orthopaedic Research Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
其他名称:
  • Electromagnetic Field Therapy
Sham treatment for 4 weeks post-surgery
其他名称:
  • Electromagnetic Field Therapy
有源比较器:Targeted pulsed electromagnetic field
Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
其他名称:
  • Electromagnetic Field Therapy
Sham treatment for 4 weeks post-surgery
其他名称:
  • Electromagnetic Field Therapy

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The average daily morphine equivalent dose consumption at 2 weeks post-surgery.
大体时间:2-week follow-up period from surgery
2-week follow-up period from surgery

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
1 and 4 weeks post-surgery
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
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
At intervals over the 4-week follow-up period
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
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
Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit
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
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.
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
OA-related medication use including analgesics, anti-inflammatories, and other non-opioids
大体时间:4 weeks post-surgery
Subjects will be required to track daily OA-related medication use including analgesics, anti-inflammatories, and other non-opioids using a daily diary.
4 weeks post-surgery
Adverse Events collected and analyzed for confirmation of device safety
大体时间:Randomization to 4 weeks post-surgery
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.
Randomization to 4 weeks post-surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Gerard A. Engh, M.D.、Anderson Orthopaedic Research Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年11月1日

初级完成 (实际的)

2012年7月1日

研究完成 (实际的)

2012年7月1日

研究注册日期

首次提交

2011年11月17日

首先提交符合 QC 标准的

2011年11月17日

首次发布 (估计)

2011年11月21日

研究记录更新

最后更新发布 (估计)

2012年7月10日

上次提交的符合 QC 标准的更新

2012年7月6日

最后验证

2012年7月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

骨关节炎,膝盖的临床试验

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3
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