Use of Pulsed Electromagnetic Fields in Reducing Arm and Shoulder Complaints in Breast Cancer Patients After Lymph Node Dissection
In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two
hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already
designed a lightweight, disposable device that can be placed around the patient's arm and
taped in place. The patient would keep the device in place for two weeks, when they return
for a followup visit and receive a fresh device to wear for an additional two weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Pain Level on Visual Analog Scale
Pain will be the primary outcome measured by patient level of pain as quantified by a visual analog scale with written descriptions, and amount of pain medication used hourly until the patient is discharged (up to a maximum of six hours postop), then daily for a total of two weeks postop.
Christine Rohde, MD
United States: Institutional Review Board
|Columbia University Medical Center||New York, New York 10032|