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Pulsed Electromagnetic Fields Reduce Postoperative Interleukin-1β, Pain, and Inflammation: A Double-Blind, Placebo-Controlled Study in TRAM Flap Breast Reconstruction Patients

Rohde, Christine H. M.D., M.P.H.; Taylor, Erin M. M.D.; Alonso, Amanda B.S.; Ascherman, Jeffrey A. M.D.; Hardy, Krista L. B.S.; Pilla, Arthur A. Ph.D.

Plastic and Reconstructive Surgery: May 2015 - Volume 135 - Issue 5 - p 808e–817e
doi: 10.1097/PRS.0000000000001152
Breast: Original Articles
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Background: Pulsed electromagnetic fields have been shown to reduce postoperative pain, inflammation, and narcotic requirements after breast reduction and augmentation surgical procedures. This study examined whether pulsed electromagnetic field therapy could produce similar results in patients undergoing unilateral transverse rectus abdominis myocutaneous (TRAM) flap breast reconstruction, a significantly more complex and painful surgical procedure.

Methods: In this double-blind, placebo-controlled, randomized study, 32 patients undergoing unilateral TRAM flap breast reconstruction received active or sham pulsed electromagnetic field therapy. Pain levels were measured by using a visual analogue scale; narcotic use and wound exudate volume were recorded starting 1 hour postoperatively. Wound exudates were analyzed for interleukin-1β.

Results: Mean visual analogue scale pain scores were 2-fold higher in the sham cohort at 5 hours and 4-fold higher at 72 hours (p < 0.01), along with a concomitant 2-fold increase in narcotic use in sham patients (p < 0.01). Wound exudate volume was 2-fold higher in the sham cohort at 24 hours (p < 0.01), and mean interleukin-1β concentration in wound exudates of sham patients was 5-fold higher at 24 hours (p < 0.001).

Conclusions: Pulsed electromagnetic field therapy significantly reduced postoperative pain, inflammation, and narcotic use following TRAM flap breast reconstruction, paralleling its effect in breast reduction patients. Both studies also report a significant reduction of interleukin-1β in the wound exudate, supporting a mechanism involving a pulsed electromagnetic field effect on nitric oxide/cyclic guanosine monophosphate signaling, which modulates the body’s antiinflammatory pathways. Adjunctive pulsed electromagnetic field therapy could impact the speed and quality of wound repair in many surgical procedures.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

New York, N.Y.

From the Division of Plastic and Reconstructive Surgery, Columbia University Medical Center; the Department of Biomedical Engineering, Columbia University; and the Department of Orthopedics, Mount Sinai School of Medicine.

Received for publication October 8, 2014; accepted November 18, 2014.

This study is registered under the name “Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery,” ClinicalTrials.gov identification number NCT01262599 (http://clinicaltrials.gov/show/NCT01262599).

Preliminary results from this study were presented at the American Society of Plastic Surgeons Annual Meeting, in New Orleans, Louisiana, October 26 through 30, 2012; and the 31st Annual Meeting of the Northeastern Society of Plastic Surgeons, in Providence, Rhode Island, September 12 through 14, 2014.

Disclosure: Dr. Rohde received a research grant from Ivivi Health Sciences, LLC, for this study. Dr. Pilla receives compensation as a senior scientific advisor to Ivivi Health Sciences and had no contact with patients in this study. Drs. Taylor and Ascherman and Ms. Alonso and Ms. Hardy have no financial interest with Ivivi Health Sciences and no financial interests or sources of support to disclose.

Christine H. Rohde, M.D., M.P.H., Division of Plastic and Reconstructive Surgery, Columbia University Medical Center, 161 Fort Washington Avenue, Room 511, New York, N.Y. 10032, chr2111@cumc.columbia.edu

©2015American Society of Plastic Surgeons