
Clinical Overview

Leading Edge Technology
SofPulse is an easy-to-place, non-invasive device that delivers targeted pulsed electromagnetic field therapy to enhance post-surgical recovery, naturally. tPEMF is an innovative process that uses proprietary technology to reduce pain, swelling and inflammation. The therapy is non-invasive and non-pharmacologic, with no known side effects and no potential for overdose or dependency. SofPulse has been
used effectively and studied extensively in soft tissue postoperative management.
Recommendations for Use
tPEMF therapy is recommended for a variety of health conditions, below are just a few of the uses for this innovative technology.
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Post-surgical and chronic pain
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Inflammation and edema
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Acute and chronic wounds
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Neuropathy
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Orthopedic conditions
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Osteoarthritis
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To promote vasodilation and angiogenesis
No Contraindications
SofPulse has no contraindications. The FDA label has indicated use, warnings and precautions (each is of a lesser concern down to precautions)
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Indications: Adjunctive use in the palliative treatment of postoperative pain and edema in the superficial soft tissue. SofPulse is not indicated as a substitute for treatment of deep tissues such as internal organs.
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Warnings: Be sure to ask the patient about possible implants before deciding to use SofPulse. If the patient has implanted leads or an implant containing lead, tPEMF therapy should not be used, even if the implant has been turned off. Examples of implanted systems that may contain lead include cardiac pacemakers and defibrillators, cochlear implants, bone growth stimulators, deep brain stimulators, spinal cord stimulators, and other nerve stimulators.
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Precautions: Should not be used during pregnancy or over the joints of skeletally immature patients. The long-term biological effects of pulsed electromagnetic energy are not known at this time.
Clinician Frequently Asked Questions
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 saline13
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:
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.
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.
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.
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.
