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临床试验/NCT01762423
NCT01762423撤回4 期

PEMF Effects on Pain After Abdominal Body Contouring

University of Pittsburgh2 个研究点 分布在 1 个国家开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
4 期
状态
撤回
试验地点
2
主要终点
Postoperative Pain Reduction

研究概览

简要总结

Body contouring surgery has a higher potential for postoperative pain and wound healing complications. The purpose of this study is to determine if pulsed electromagnetic field (PEMF) devices can reduce the pain and complications associated with this type of surgery.

Pulsed electromagnetic field (PEMF) devices have been shown to be effective treatments to decrease healing time in nonunion fractures and pressure ulcers, and to reduce pain in whiplash injuries, persistent neck pain, and chronic lower back pain. These devices have been FDA approved for treatment of pain and edema (510(k) number: K070541). More recently, PEMF devices have been shown to decrease postoperative pain and narcotic use in breast augmentation patients. This study seeks to determine if PEMF will also cause similar effects in the more complex procedures performed on body contouring patients. The specific aims of this study are:

  1. Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain reduction in abdominal body contouring patients.
  2. Evaluate if adjunct PEMF therapy will decrease the postoperative use of narcotic pain relievers in abdominal body contouring patients.

PEMF devices have been shown to be effective in reduction of pain and pain medication use in breast augmentation patients. No literature has shown if PEMF is an effective adjunct to decrease pain or pain medication use in the abdominal body contouring patient. A decrease in pain would result in a better experience for patients and a reduction in pain medication may decrease complications associated with these medications. The PEMF therapy device being used in this study is a non-significant risk device because it is noninvasive and does not present a potential for serious risk to the health, safety, or welfare of a subject.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18 years and older and able to provide informed consent
  • Eligible for and have agreed to be scheduled for elective abdominal body contouring surgery
  • Willing and able to comply with all study procedures.

排除标准

  • Inability to provide informed consent
  • Patients having multiple procedures concurrently except liposuction.
  • Current use of oral steroids as determined through patient history and medical record review
  • Current narcotic use as determined through patient history or medical record review
  • Current nerve or pain disorder.
  • Recent (1 month) coronary stent or implanted medical device (e.g. pacemaker).
  • Pregnancy (demonstrated by a positive result of a urine pregnancy test)
  • Based upon surgeon judgement and the results of screening procedures, patient is not a suitable candidate for surgery.

结局指标

主要结局

Postoperative Pain Reduction

时间窗: Immediately postoperatively through 6 days postoperative

Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain reduction in abdominal body contouring patients.

次要结局

  • Postoperative Narcotic Use(Immediately postoperative through 6 day postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

J. Peter Rubin, MD

Principal Investigator

University of Pittsburgh

研究点 (2)

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