Sample tPEMF Studies: Details

Pain and Narcotic Use

Effects of Pulsed Electromagnetic Fields on Interleukin-1ß and Postoperative Pain: A Double-Blind, Placebo-Controlled, Pilot Study in Breast Reduction Patients

Study Design

Double-blind, placebo-controlled, randomized study
24 patients undergoing breast reduction surgery
Pain levels measured by VAS and narcotic use recorded
Wound exudates analyzed for interleukin (IL) 1ß, tumor
necrosis factor (TNF)-a, vascular endothelial growth factor
(VEGF), or fibroblast growth factor (FGF)-2 concentrations

Results

57% decrease in mean pain scores at one hour (p<0.01)
300% decrease in mean pain scores at 5 hours (p<0.001)
2.2-fold reduction in narcotic use in active patients (p=0.002)
Mean IL-1ß concentration in wound exudates of treated patients
was 275% lower (p<0.001)
No significant difference in TNF-a, VEGF, or FGF-2 concentrations

Conclusion

Pulsed electromagnetic field therapy significantly reduced postoperative pain and narcotic use in the immediate postoperative period. The reduction of IL-1ß in the wound exudate supports a mechanism that may involve manipulation of the dynamics of endogenous IL-1ß in the wound bed by means of a pulsed electromagnetic field effect on nitric oxide signaling, which could impact the speed and quality of wound repair.

Reference: 1Rhode – “Effects of Pulsed Electromagnetic Fields on Interleukin-1 and Postoperative Pain: A Double-Blind, Placebo-Controlled, Pilot Study in Breast Reduction Patients.” Plastic and Reconstructive Surgery, 2010

Pain1

Pain2

Effects of Pulsed Electromagnetic Fields on Postoperative Pain: A Double-Blind Randomized Pilot Study in Breast Augmentation Patients

Study Design

Double randomized study-blind, placebo-controlled,
randomized study
42 patients undergoing breast augmentation, separated into three cohorts
- Bilateral active
- Bilateral sham
- Unilateral active + unilateral sham’
Pain levels measured by VA and postoperative analgesic medication
use recorded

Results

Pain level in active cohort decreased by nearly a factor of 3,
compared to sham cohort (p<0.001)
Postoperative pain medication decreased nearly 3x faster in the active
versus sham cohort (p<0.001)

Conclusion

Pulsed electromagnetic field therapy, adjunctive to standard of care, can provide pain control with a noninvasive modality and reduce morbidity due to pain medication after breast augmentation surgery.

Reference: Heden P., Pilla A. Effects of Pulsed Electromagnetic Fields on Postoperative Pain: A Double-Blind Randomized Pilot Study in Breast Augmentation Patients. Aesth Plast Surg. 2008

Edema and Swelling

Effects of Pulsed Electromagnetic Field Therapy on Pain, Inflammation and Edema 10

Studies have also evaluated the effects of SofPulse on post-operative inflammation and rate of tissue repair. In this double-blinded, randomized, sham-controlled study, inflammation was evaluated and quantified by analyzing wound exudates and measuring the level of interleukin (IL)-1ß, which is an objective marker of inflammation.The results showed a 275% reduction in IL-1 ß at 18 hours post-op, compared to the sham cohort. 8

Targeted pulsed electromagnetic therapy (tPEMF) has also been studied
and validated in standard models for assessing edema and pain. A double
blinded, sham-controlled, randomized study was performed at the Indiana
University School of Medicine to evaluate the increase in edema after the
injection of an inflammatory agent. The results confirm that SofPulse has
a significant effect on edema in an animal model which is routinely employed
as an accurate predictor of the effect of anti-inflammatory drugs and
physical modalities on humans.

Study Design

Double-blind, placebo-controlled, randomized study
Validated model of inflammation 11, 12
32 male Sprague-Dawley rats (200-250g), separated into two cohorts:
SofPulse and Sham (originally referred to as Torino and Torino Sham).
Paw edema was induced by intraplantar injection of 0.1ml of 2%
carrageenan in saline 13
Edema was measured, after 225 minutes, with a water displacement
plethysmometer

Results

Non-significant decrease (8%) in mean pain threshold vs. baseline for
active cohort.
Significant decrease (26%) in mean pain threshold vs. baseline for
cohort (p<0.001)
Mean pain threshold was reduced by nearly 3x more in sham cohort
vs. active cohort
Mean edema increase in sham cohort was 1.7x greater than the active
cohort at 225 minutes
Pain threshold was reduced by approximately two-fold at 360 min, compared
with approximately three-fold for SofPulse at 225 minutes

Conclusion

The results show that the SofPulse had a significant effect on pain and edema in an animal model which is routinely employed as an accurate predictor of the effect of anti-inflammatory drugs and physical modalities on humans.

References:

8. Heden P., Pilla A. Effects of Pulsed Electromagnetic Fields on Postoperative Pain: A Double-Blind Randomized Pilot Study in Breast Augmentation Patients. Aesth Plast Surg. 2008

10. Johnson MT. Effect of Pulsed Electromagnetic Field Therapy on Pain, Inflammation, and Edema in the Rat Hind Paw. Indiana State University Scholl of Medicine, Department of Microbiology and Immunology. 2008.

11. Morris CJ (2003) Carrageenan-induced paw edema in the rat and mouse. Methods Mol Biol. 225:115-121.

12. Anseloni VC, Ennis M, Lidow MS (2003) Optimization of the mechanical nociceptive threshold testing with the Randall-Selitto assay. J Neurosci Methods. 131:93-97

13. al-Swayeh OA, Clifford RH, del Soldato P, Moore PK (2000). A comparison of the anti-inflammatory and anti-nociceptive activity of ntroaspririn and aspirin. Br J Pharmacol. 129:343-350.

Angiogenesis

Targeted electromagnetic field therapy (tPEMF) has been used successfully in various clinical applications for the treatment of post-surgical pain and edema, chronic wound care and to promote vasodilation and angiogenesis. 14

Studies on a transplanted arterial loop in the groin of a rat (Figure A - control) clearly demonstrate the angiogenesis
that occurs after 8 weeks of 30 minute pulsed electromagnetic field therapy, given twice daily (Figure B). Angiogenesis was
reported to be 500% greater in the treated animals (courtesy Roland et al15).

14. Strauch
15. Roland D, Ferder M, Kothuru R, Faierman T, Strauch B. Effects of pulsed magnetic energy on a microsurgically transferred vessel. Plast Reconstr Surg 2000; 105:1371-1374.