PEMF Effects on Pain After Abdominal Body Contouring (PEMF)

February 19, 2013 updated by: J. Peter Rubin, MD, University of Pittsburgh

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Center for Innovation in Restorative Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Device

Device Placement:

Upon completion of the subjects' standard of care body contouring surgery, the device will be placed directly on the operative dressings within an unobtrusive binder with Velcro strips and will be activated before the subject leaves the OR. Subjects will then be educated on the functionality and interpretation of the user interface of the device. They will be educated on the application, removal, and return of the device.

Active Devices The device will be activated at the time of placement. The active devices are programmed to automatically deliver treatment. Each treatment duration is 15 minutes. The active device delivers treatment every 2 hours. A light will flash on the device when the PEMF begins and will continue to flash every second until the end of the treatment. Between treatments the device will be in "sleep mode" and the light will flash every 5 seconds.
Device: Active Device (IVIVI SofPulse)
Other Names:
  • IVIVI SofPulse
Sham Comparator: Sham Device

Device Placement:

Upon completion of the subjects' standard of care body contouring surgery, the device will be placed directly on the operative dressings within an unobtrusive binder with velcro strips and will be activated before the subject leaves the OR. Subjects will then be educated on the functionality and interpretation of the user interface of the device. They will be educated on the application, removal, and return of the device.

Sham Devices The sham devices mirror the active device with the exception of the delivery of the PEMF. The sham device will be "activated" at the time of placement. A light will flash on the device when the SHAM PEMF begins and will continue to flash every second until the end each treatment interval. While in "sleep mode" the device will not deliver treatment and the light will flash every 5 seconds.
Device: Sham Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Reduction
Time Frame: Immediately postoperatively through 6 days postoperative
Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain reduction in abdominal body contouring patients.
Immediately postoperatively through 6 days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Narcotic Use
Time Frame: Immediately postoperative through 6 day postoperative
Evaluate if adjunct PEMF therapy will decrease the postoperative use of narcotic pain relievers in abdominal body contouring patients.
Immediately postoperative through 6 day postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

January 4, 2013

First Posted (Estimate)

January 7, 2013

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 19, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO12070504

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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