PEMF Effects on Pain After Abdominal Body Contouring

This study has been withdrawn prior to enrollment.
(Funding issues.)
Sponsor:
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01762423
First received: January 3, 2013
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Abdominal Body Contouring Surgery
Postoperative Pain
Device: Active Device (IVIVI SofPulse)
Device: Sham Device
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PEMF Effects on Pain After Abdominal Body Contouring

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Postoperative Pain Reduction [ Time Frame: Immediately postoperatively through 6 days postoperative ] [ Designated as safety issue: No ]
    Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain reduction in abdominal body contouring patients.


Secondary Outcome Measures:
  • Postoperative Narcotic Use [ Time Frame: Immediately postoperative through 6 day postoperative ] [ Designated as safety issue: No ]
    Evaluate if adjunct PEMF therapy will decrease the postoperative use of narcotic pain relievers in abdominal body contouring patients.


Enrollment: 0
Study Start Date: December 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762423

Locations
United States, Pennsylvania
UPMC Center for Innovation in Restorative Medicine
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: J. Peter Rubin, MD University of Pittsburgh
  More Information

Publications:

Responsible Party: J. Peter Rubin, MD, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01762423     History of Changes
Other Study ID Numbers: PRO12070504
Study First Received: January 3, 2013
Last Updated: February 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014