PEMF Effects on Pain After Abdominal Body Contouring (PEMF)
Abdominal Body Contouring Surgery, Postoperative Pain
About this trial
This is an interventional treatment trial for Abdominal Body Contouring Surgery
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.
Sites / Locations
- UPMC Center for Innovation in Restorative Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active Device
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. 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 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.