SofPulse® Electroceutical™ Therapy

SofPulse® uses targeted microcurrents to transmit gentle pulses to the tissue to help reduce swelling and speed up the natural recovery process. The low levels of microcurrent are completely safe and in fact, are 1000 times lower than those emitted by a mobile phone.

Treatment with SofPulse allows you to better manage pain without the adverse side effects of narcotics and anti-inflammatory medication.  SofPulse reduces edema, the resulting pain level and thereby decreases the requirement for medication.  With less pain and less medication, you can move around sooner, which stimulates the body’s natural response to healing. For more information please visit: www.sofpulse.com

[SofPulse® Electroceutical™ Therapy]

Breast Reconstruction

Breast reconstruction is a surgical procedure that attempts to bring the breast to normal size and shape following mastectomy for Breast Cancer.

You may have a flap reconstruction in which the surgeon will use your own muscle, fat, and skin. You will have a linear incision across your belly similar to a tummy tuck. While both the new breast and belly will have pain, most will come from the belly. This type of reconstructions can be referred to as Free Flap (DIEP, SGAP) or Pedicle TRAM Flap. Another reconstruction option is to have tissue expanders or implants placed to create the new breast. In this case there is no surgery on the belly and pain will come from pressure on the chest wall. You should talk over with your surgeon which procedure is best for you.

The most common method of controlling post-operative pain is through the use of narcotic medication.  This can be taken by mouth or from a PCA pump which administers narcotics through an I/V.  Some hospitals or surgeons may use a pain pump to provide numbing medicine to the surgical site from a catheter placed in the body.  In either situation you will still potentially be faced with side effects of the narcotics which may include nausea, dizziness, drowsiness, vomiting, dehydration, etc.

With SofPulse, there is an improved way to manage the pain and help you recover from reconstruction faster.

  • Less Pain
  • Less pain medication and associated side effects
  • Faster and more comfortable surgical recovery

 

This is accomplished with a device placed over bandages and perhaps even outside your surgical gown.

Cosmetic Surgery

Cosmetic surgery includes surgical and nonsurgical procedures that reshape structures of the body and face in order to improve appearance and self-esteem. SofPulse has been used in cosmetic surgery performed in the surgeon’s office, in hospitals, in outpatient surgery centers or even in ambulatory surgery centers and medical spas. SofPulse is becoming standard of care for reducing discomfort, pain and swelling.

SofPulse Decreases Pain

Patients who use SofPulse therapy report half as much post-procedure discomfort as patients who do not use the therapy.5,6

SofPulse Reduces Swelling

SofPulse enhances the release of the signaling molecule nitric oxide, which is involved in the anti-inflammatory process and therefore helps to reduce pain..

SofPulse Reduces the Need for Prescription Medications

Because patients experience far less pain when using SofPulse, they also require far less prescription medications. Studies have shown a greater than 2.2-fold reduction in narcotic use over the first 48 hours post-procedure.

Although inflammation is a natural and necessary part of the healing process, the pain that accompanies the inflammation can be debilitating.  The most common method of controlling pain is through the use of narcotic and anti-inflammatory medication.  Narcotics have many side effects including nausea, dizziness, drowsiness, vomiting, lower limb weakness, dehydration, etc.   Some types of anti-inflammatory medication actually slow the body’s natural process of healing.7

 
5Heden 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.
6Rhode C, Chiang A, Adipoju O, Casper D, Pilla A.  Effects of Pulsed Electromagnetic Fields on Interleukin-1β and Postoperative Pain:  A Double-Blind, Placebo-Controlled, Pilot Study in Breast Reduction Patients.  Plast. Reconstr. Surg. 2010; 125: 1.
7Stadelmann WK, Digenis AG, Tobin, GR. (1998). “Impediments to Wound Healing”.  The American Journal of Surgery.  176(2: Supp1); 39S-47S

Pain Reduction in Early Knee Osteoarthritis

Non-invasive electromagnetic field therapy produces rapid and substantial pain reduction in early knee osteoarthritis: a randomized double-blind pilot study

Nelson FR, Zvirbulis R, Pilla AA

Published 2013 in Rheumatology International – DOI: 10.1016/j.joca.2012.02.265

Abstract

This study examined whether a non-thermal, non-invasive, pulsed electromagnetic field (PEMF), known to modulate the calmodulin (CaM)-dependent nitric oxide (NO)/cyclic guanosine monophosphate (cGMP) signaling pathway, could reduce pain in early knee OA. This randomized, placebo-controlled, double-blind pilot clinical study enrolled 34 patients. Patient selection required initial VAS ≥4, 2 h of standing activity per day, and no recent interventions such as cortisone injections or surgery. Results showed VAS pain score decreased in the active cohort by 50 ± 11% versus baseline starting at day 1 and persisting to day 42 (P < 0.001). There was no significant decrease in VAS versus baseline at any time point in the sham cohort (P = 0.227). The overall decrease in mean VAS score for the active cohort was nearly threefold that of the sham cohort (P < 0.001). The results suggest that non-thermal, non-invasive PEMF therapy can have a significant and rapid impact on pain from early knee OA and that larger clinical trials are warranted.

[Mean Visual Analogue Scale (VAS)]


SofPulse® Economics

A survey conducted by the American Hospital Association reports that 7 out of 10 hospitals have seen a decline in their financial health over the recent years. Demand and hospital expense is increasing but reimbursement is declining and there are fewer donations/investments being made. In order for a hospital to maintain viability, they must focus on improving patient care and reducing operating expense.

Management of pain is a central issue in the delivery of high quality patient care. Intravenous patient-controlled analgesia (IV PCA) with opioids is common; however it carries significant risks and costs. The cost of IV PCA errors was $388 million in 200416. A product that allows for accelerated post-surgical recovery and a decrease in post-op pain and narcotic use may reduce the risk of these IV PCA errors and may also reduce hospital length of stay and save the hospital an average of $1,000/day.17,18,19

SofPulse provides a solution that will improve patient outcomes and provide operational and financial benefits to the hospital. SofPulse facilitates the natural recovery process with improved outcomes and reduced cost.

If you would like additional information, please contact us at info@sofpulse.com.

16.Meissner, Nelson & Hicks, 2009
17.Taheri PA, Butz DA, Greenfield LJ. Length of stay has minimal impact on the cost of hospital admission. J Am Coll Surg. 2000;191:123�130.
18.Rothberg MB, Abraham I, Lindenauer PK, Rose DN. Improving Nurse-to-Patient Staffing Ratios as a Cost-Effective Safety Intervention. Med Care 2005;43: 785�791
19.Whelan C. The New Economics of Healthcare: Evaluating Medical Technologies Based on Actual Value as a Growth Strategy for Healthcare Providers. Frost & Sullivan whitepaper. 2010.

Pain, Edema and Narcotic Use

Studies have been performed to evaluate the impact of SofPulse on pain and narcotic use after breast reduction and breast augmentation procedures. Double blinded, sham-controlled studies were performed where patients were randomized to either SofPulse or sham. Pain levels were measured using a visual analog scale (VAS) and narcotic use was recorded as amount of pills consumed. These studies showed that SofPulse significantly reduced postoperative pain and narcotic use after breast reduction and augmentation procedures.

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

Rohde C, Chiang A, Adipoju O, Casper D, Pilla A.

Published 2010 in Plastic Reconstruction Surgery – DOI: 10.1097/PRS.0b013e3181c9f6d3

Study Design

  • Double-blind, placebo-controlled, randomized study
  • 24 patients undergoing breast reconstruction surgery
  • Pain levels measured by VAS and narcotics use recorded
  • Wound exudates analyzed for Interleukin (IL) 1β, tumor necrosis factor (TNF)-α, vascular endothelial growth factor (VEGF), and 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<0.01)
  • 2.2-fold reduction in narcotic use in active patients (p=0.002)
  • Mean IL-1β concentration in wound exudates of treated patients was 275% lower (p<0.001)
  • No significant difference in TNF-α, VEGF, or FGF-2 concentrations

 

Conclusions

Pulsed electromagnetic field therapy significantly reduced postoperative pain and narcotic use in the immediate postoperative period. 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 by means of a pulsed electromagnetic field effect on nitric oxide signaling, which could impact the speed and quality of wound repair.

Reduced Narcotic Use

Reduced Interleukin-1β in Wound Exudates

Additional Publications

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.

Note: Endonovo Therapeutics, Inc. is not responsible for the content presented in the following articles and website links

A Double-Blind, Placebo-Controlled, Pilot Study in Breast Reduction Patients.
Effects of Pulsed Electromagnetic Fields on Interleukin-1β and Postoperative Pain.
Rohde C, Chiang A, Adipoju O, Casper D, Pilla A.  Plast. Reconstr. Surg. 2010; 125: 1.

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

Johnson MG, Ramanathan M, Owegi R, Pilla AA.
“Modulation of Carrageenan-Induced Paw Edema and Hyperalgesia in the Rat with Pulsed Magnetic Field Therapy.,”
BEMS Annual Meeting, June 2008

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

A Review of Scientific Breakthroughs and Current Understanding of PEMF Therapy.
Evidence-Based Use of Pulsed Eletromagnetic Field Therapy in Clinical Plastic Surgery.
Strauch B, Herman C, Dabb R, Ignarro L, Pilla A.  Aesthetic Surg. 2009;29:135-143.

Pulsed Magnetic Field Therapy Increases Tensile Strength in a Rat Achilles’ Tendon Repair Model.
In-vivo Study Demonstrating Significant acceleration in Tendon Repair in the Rat Animal Model.
Strauch B, Patel M, Rosen D, Mahadevia S, Brindzei N, Pilla A. J Hand Surg 2006.

Pulsed Magnetic Fields Accelerate Cutaneous Wound Healing in Rats
In-vivo Assessment in the Rat Animal Model.
Strauch B, Patel M, Navarro J, Berdichevsky M, Yu H, Pilla A.  Plast. Reconstr. Surg 2007.

Pulsed Magnetic Fields Applied to a Transferred Arterial Loop Support the Rat Groin Composite Flap.
In-Vivo Study Demonstrating Significant Improvement in Flap Survival in a Standard Model.
Weber R, Navarro A, Wu J, Yu H, Strauch B. Plast. Reconstr. Surg. 2004.

Effects of Pulsed Magnetic Energy on a Microsurgically Transferred Vessel.
In-Vivo Study Demonstrating that Pulsed Magnetic Energy increases neovascularization in a Standard Model.
Roland D, Ferder M, Kothuru R, Faierman T, Strauch B. Plast. Reconstr. Surg. 105:1371, 2000.

A Double Blind Pilot Clinical Study on Spinal Cord Injured Patients with Pressure Ulcers.
In-Vivo Study Demonstrating that Pulsed Magnetic Energy Enhances Healing of Chronic Wounds and Reduces Pain and Suffering.
Kloth LC, Berman JE, Jeutter DC, Pilla AA, Epner ME.  Electricity and Magnetism in Biology and Medicine.  F Bersani ed.  Plenum, NY. 1999. pp 875-878.

Order SofPulse® Today

SofPulse® is a prescription device and cannot be sold directly to patients. If you’re a patient, click here for more info about How To Get the SofPulse®.

To place an order for SofPulse® or SofPulse® Duo, please contact our customer service department at orders@sofpulse.com.

 Product #  Product Name
Quantity
Packaging
 1IVSP7.5  SofPulse 7.5″ Single Patient Use
5
Box
 1IVSPDUOWHT  SofPulse Duo Single Patient Use
5
Box

 

SofPulse
6320 Canoga Ave. 15th Floor
Woodland Hills, CA 91367

Phone 800-701-1223 Ext 108
Email: info@sofpulse.com