FDA Cleared Medical Device...
clinically proven to significantly speed the healing process and reduce the need for pain medications
Clinical Research Library
Post-Surgical Pain and Inflammation | Wound Healing | Orthopedic/Osteoarthritis
Basic Scientific Research / Other Applications / Review Articles
Over the past 10 years there have been numerous clinical trials and basic science papers published in peer-reviewed journals. After FDA clearance in December of 2008, clinical trials continue to be published. Additional studies are ongoing.
Post-Surgical Pain and Inflammation
87% decrease in post-surgery pain over control
Heden – “Effects of Pulsed Electromagnetic Fields on Post-Operative Pain: A Double-Blind Randomized Pilot Study in Breast Augmentation.” Aesthetic Plastic Surgery, 2008. / See Attached Study
57% decrease in pain at one-hour post-op and a 300% decrease at five hours and 2.2 less narcotics. 300% less IL-1B (inflammatory Marker)
Rhode – “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. / See Attached Study
50-62% Reductions in pain and narcotics use in bi-lateral mastectomy
Gabriel, Maxwell – “Effects of Pulsed Electromagnetic Field Therapy on Post-Surgical Pain: A Randomized Placebo Controlled Double Blind Study in Breast Reconstruction Patients.” The Plastic Surgeons of Loma Linda University, 2009. |
See Attached Study
300% decrease in pain and 66% reduction in edema
Johnson – “Carrageenan-Induced Inflammation in the Rat Hind Paw (Indiana State University) – provided to FDA to validate labeled indication for SofPulse.” Terre Haute, Indiana (submitted to FDA, 2007). | See Attached Study
57% reduction in pain at one-hour post-op, 55% less pain medication, 50% less inflammation (IL-1Beta)
Rhode – “Effects of Pulsed Electromagnetic Fields on Interleukin-1 Beta and Postoperative Pain: A Double-Blind, Placebo-Controlled, Pilot Study in Breast Reduction Patients, Plastic and Reconstructive Surgery.” Columbia University Medical Center, NYC, Plastic and Reconstructive Surgery, 2010. \ See Attached Study
tPEMF significantly reduced post-operative pain 400%, inflammation 400% (IL-1Beta), and narcotic use 200%-600% following TRAM flap breast reconstruction which may reduce length of in-patient hospital stays, reduced mortality
Rhode, et al, – “Pulsed Electromagnetic Fields Reduce Postoperative Interleukin-B, Pain, and Inflammation: A Double-Blind, Placebo-Controlled Study in Tram Flap Breast Reconstruction.” Plastic and Reconstructive Surgery. Columbia University Medical Center, NYC., Plastic and Reconstructive Surgery, 2015. | See Attached Study
Wound Healing
44% - 59% increased wound tensile strength
Strauch – “Pulsed Electromagnetic Fields Accelerate Cutaneous Wound Healing in Rats, Plastic and Reconstructive Surgery”. Albert Einstein College of Medicine and Montefiorre Medical Center, NYC. Plastic and Reconstructive Surgery, 2007.
100% skin flap success with PEMF vs 0% without use of PEMF at 8 weeks post op
Weber et al – “Pulsed Magnetic Fields Applied to a Transferred Arterial Loop Support the Rat Groin Composite Flap.” Albert Einstein College of Medicine NYC, Plastic and Reconstructive Surgery, 2004. | See Attached Study
350% increase in neovascularization
Roland – “Effects of Pulsed Magnetic Energy on a Microsurgically Transferred Vessel.” Albert Einstein College of Medicine, NYC, Plastic and Reconstructive Surgery, 2000 | See Attached Study
800% increase in number of pressure ulcer wounds in spinal cord injury patients at a VA Hospital healed.
Kloth – “Effect of Pulsed Radio Frequency Stimulation on Wound Healing: A Double-Blind Pilot Clinical Study.” Electricity and Magnetism in Biology and Medicine, 1999. | See Attached Study
29% increase in blood perfusion immediately following exposure to PEMF
Mayrovitz – “Effects of Pulsed Electromagnetic Fields on Skin Microvascular Blood Perfusion”, Wounds Journal - 2002
This book chapter reviews and validates the effectiveness of PEMF in suppressing pain and tissue healing
Kloth, Pilla – “Wound Healing – Evidence-Based Management” (Chapter 27 “Electromagnetic Stimulation for Wound Repair”) - 2010 | See Attached Study
Significant increase in microcirculation in legs of patients with diabetic and foot and toe ulcers attributed to either or both further arteriolar dilation or vasodilation of previously non-perfused vessels.
Mayrovitz, Larsen – “A Preliminary Study to Evaluate the Effect of Pulsed Radio Frequency Field Treatment of Lower Extremity Peri-Ulcer Skin Microcirculation of Diabetic Patients” – Wounds, 1995. | See Attached Study
65% reduction in use of pneumatic dressings, 33% reduction in healing time and reduced nursing time by adding SofPulse therapy to their wound-care protocol.
Hall – Advance for Providers of Post-Acute Care - 2005 | See Attached Study
70% of wound surface decreasing in 1 week, 60% reduction in wound care costs mostly from reduction in NPWT rentals.
Luu, Cher, Howard – “Integrating Electrotherapy into Everyday Complex Wound Care.” Continuum/The ALTHA Journal, 2008. | See Attached Study
Orthopedic / Osteoarthritis
700% decrease in edema in a prospective, randomized placebo-controlled study of 395 patients with Grade I and II Ankle Sprains at 10 University Sites.
Pilla – “State of The Art in Electromagnetic Therapeutics: Soft Tissue Applications: Electricity and Magnetism in Biology and Medicine.” 1999 | See Attached Study
Basic Scientific Research / Other Applications / Review Articles
PEMF therapy has been used successfully in the management of postsurgical pain and edema, the treatment of chronic wounds, and in facilitating vasodilatation and angiogenesis. This review article was co-authored by a multidisciplinary group of medical doctors and Ph. D researchers including Nobel Laureate in Medicine, Louis Ignarro, Ph.D. who elucidated nitric oxide’s role in the body’s anti-inflammatory response.
Strauch, Herman, Dabb, Ignarro, Pilla – “Evidence-Based Use of Pulsed Electromagnetic Field Therapy in Clinical Plastic Surgery.” Aesthetic Surgery Journal., 2009. | See Attached Study
Clinical effects in this group of “no option cardiac patients” showed steady improvement in clinical symptoms which persisted at two months after cessation of PEMF therapy. Clinical Improvement lasted for 25 months after cessation of treatment suggesting longer treatment regimen may be warranted – Cleveland Clinic.
Shen, Ignarro, Pilla, - “Use of Pulsed Electromagnetic Fields for Ischemic Cardiomyopathy Therapy (Effect Trial): A Randomized Double-Blind, Parallel, Placebo-Controlled Prospective Trial.” Poster, American College of Cardiology Meeting 2007. | See Attached Study
Review article of PEMF modalities and their published therapeutic benefits for bone and wound repair and chronic and acute pain relief.
Pilla, 2006 “Mechanisms and Therapeutic Applications of Time-Varying and Static Magnetic Fields.” Department of Orthopedics, Mount Sinai School of Medicine, NYC. | See Attached Study
Study presenting experimental evidence of PEMF acting as first messengers in calmodulin (CaM)-dependent signaling pathway. Calcium/CaM binding is thought to be the trigger for release of nitric oxide in the body, critical to the anti-inflammatory process.
Pilla, 2005 – “EMF as First Messengers in Biological Signaling.” Internal Company Research, not published |
See Attached Study