Clinical trial NCT01762423: PEMF Effects on Pain After Abdominal Body Contouring
Official title: PEMF Effects on Pain After Abdominal Body Contouring
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Abdominal Body Contouring Surgery
Postoperative Pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Postoperative Pain Reduction
timeFrame: Immediately postoperatively through 6 days postoperative
Secondary outcomes:
measure: Postoperative Narcotic Use
timeFrame: Immediately postoperative through 6 day postoperative
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Center for Innovation in Restorative Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: J. Peter Rubin, MD
role: PRINCIPAL_INVESTIGATOR
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