|89th Annual Meeting Abstracts
Pulsed Electromagnetic Fields Decrease IL-1β and Post-Operative Pain: A Double-Blind, Placebo-Controlled Study in Breast Reduction Patients
Christine Rohde, M.D.1, Austin Chiang, B.A.1, Omotinuwe Adipojou, M.D.1, Diana Casper, Ph.D.2, Arthur A. Pilla, Ph.D.3.
1Columbia University Medical Center, NewYork-Presbyterian Hospital, New York, NY, USA, 2Neurosurgery Laboratory, Montefiore Medical Center and the Albert Einstein College of Medicine, Bronx, NY, USA, 3Department of Biomedical Engineering, Columbia University; Department of Orthopedics, Mount Sinai School of Medicine, New York, NY, USA.
PURPOSE: Surgeons seek new methods of pain control to reduce side effects and speed post-operative recovery. Pulsed electromagnetic fields (PEMF) are effective for bone and wound repair, and pain and edema reduction. The mechanism of PEMF-mediated clinical effects is postulated to involve CaM-dependent activation of nitric oxide (NO) synthase to produce NO, and the subsequent stimulation of cGMP formation, which plays an orchestrating role in tissue repair. This study examined whether the use of PEMF reduced post-operative pain, and whether the effect of PEMF on post-operative pain was associated with differences in levels of cytokines and growth factors in the wound bed.
METHODS: In this double-blind, placebo-controlled, randomized study, 24 patients undergoing breast reduction for symptomatic macromastia were enrolled. Patients were randomly assigned either a disposable dual coil, active PEMF device (SofPulse Duo, Ivivi Technologies, Inc., Montvale, NJ), or a sham device. The PEMF signal, configured, a priori, to modulate Ca2+ binding to CaM, consisted of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The induced electric field was 32 ± 6 mV/cm in each breast. Breast reductions were performed by the same surgeon (CR) using standard breast reduction techniques with superomedial pedicles. Use of PEMF was the only addition to the standard of care. Pain levels were measured by a visual analog scale, and narcotic use was recorded. Wound exudates from Jackson-Pratt drains were analyzed for IL-1β, TNF-α, VEGF, and FGF-2.
RESULTS: PEMF produced a 57% decrease in mean pain scores at 1 hour (P < 0.01), and a 300% decrease at 5 hours (P < 0.001), persisting to 48 hours post-op in the active versus the control group. The mean pill count over the first 48 post-operative hours (using oxycodone/acetaminophen equivalents) in the active group was 5 ± 0.9 compared with 11 ± 1.2 in the sham group, demonstrating a significant, and concomitant, 2.2-fold reduction in narcotic use in patients treated with PEMF (P = 0.002). IL-1β varied from 350% lower in exudates from active group patients collected at 1 hour (P < 0.001), to 300% lower at 3 hours (P < 0.001), to 200% lower at 6 hours (P < 0.001), remaining at 200% lower at 15-24 (average = 18) hours post-op (P < 0.01), than the sham group at the equivalent post-op time. These results correlate well with the temporal reduction in mean VAS pain scores, and in the use of pain medication by patients in the active cohort. There were no significant differences in TNF-α, VEGF, and FGF-2 concentrations.
CONCLUSION: PEMF therapy significantly reduced post-operative pain and narcotic use in the immediate post-operative period after elective breast reduction surgery. The reduction of IL-1β in the wound exudate supports a mechanism that may involve manipulation of the dynamics of endogenous IL-1β in the wound bed via a PEMF effect on nitric oxide signaling, which could impact the speed and quality of wound repair.