Interviews / Case reports

Excerpt of an Interview with Pain Management Specialist Dr. Erin Troy
 Muller Veterinary Hospital and The Canine Rehabilitation Center, California

“If I have a patient with a diagnosis of something more than pain – osteoarthritis, non-healed fracture, post-op cruciate ligament, post-op hip replacement, IVDD – I recommend the Loop. I talk to families very frankly, letting them know that it’s non-invasive and that there are no side effects – two things I cannot say about drugs. There’s a good amount of human literature that supports the technology behind it. I talk with them about the convenience, because you can’t get any more convenient than something you can do in your own home. I think every pet owner should have one, provided they can learn how and where to use it.”

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Excerpt from an Interview with Dr. Laurie McCauley
DVM, DACVSMR, CCRT, CVA, CVC, American Holistic Veterinary Medicine Association

“We commonly use the Assisi Loop for acute pain with patients that have had back or neck injuries. We also use it for post-op orthopedic patients – for example post-cruciate injury or surgery. The Assisi Loop® is a great tool for people who travel a distance to see us. It’s something we can send home with them to use as needed. My own personal dachshund had severe neck pain when he was 11 years old. We were considering surgery as he hates acupuncture and would struggle when we attempted to insert needles. We were also unable to perform chiropractic therapy with him. It was just too painful for him. We switched to a more hands-off approach—we used the Assisi Loop, essential oils, and laser. Within 24 hours of switching, he was significantly better. Surgery was never performed and he is doing great.”

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Case Presented by Dr. Aurelio Chaux
Cedar Sinai Hospital, Los Angeles

A colt, Retorno de Maria, was out to pasture when he was kicked in the leg, opening a large wound. The decision was made not to suture the skin and instead to wash the wound thoroughly, cover it with antiseptic ointment and wrap the leg. Treatment with the Loop was started immediately. The leg was wrapped for the first two days of treatment only and the colt received no other treatment or medications. “To my surprise, the wound had healed completely and the remaining scar is small, there is no residual pain and movement in the leg is normal. One month later, there is no swelling or lameness.”

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Case Presented by Dr. Eric Lewis
Bell Road Animal Medical Center, Montgomery

The dog Petey was abandoned on a hot summer day in Montgomery, Alabama. Someone found him and brought him to the Bell Road Animal Medical Center. Dr. Eric Lewis began treating Petey’s wounds immediately. Even with newer technology like the therapy laser, the extent of Petey’s wounds warranted a delayed healing process, but Dr. Lewis was shocked at the speed of healing using the Assisi Loop®. “It’s taken at least 30% less time to heal than I thought it would. I expected it to go fast because I’ve certainly seen the laser make a difference, but it went faster because the Assisi Loop was involved.”

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Case Presented by Lis Conarton

LVT, CCRP, Veterinary Medical Center, New York

“Autumn is a spirited 18-year old Maine Coon who was suffering from long-term effects of osteoarthritis and chronic inflammation, which decreased her quality of life. Shortly after beginning a physical rehabilitation program we added on the Assisi Loop®. This addition allowed Autumn’s owner to provide therapy at home which was otherwise not possible. Autumn’s owner noticed a change almost immediately. Autumn never tolerated massage or grooming, but seemed to enjoy Loop treatments. The ability for owners to continue treatment at home is essential and Assisi Loop therapy provides this for Autumn and her family.”

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Case Presented by Dr. Erin Troy

Muller Veterinary Hospital and The Canine Rehabilitation Center, California

Millie is a 7-year-old Labrador Retriever. She had a sudden flare of her multi-limb osteoarthritis and was suffering from a lot of pain. It was nearly impossible for her to stand or walk by herself. She has permanent Inflammatory Bowel Disease. As a result, she has dietary and medication restrictions and minimal treatment options. Dr. Troy initiated treatment with the Assisi Loop® and within 10 days, Millie was not only walking and climbing stairs again but able to get in a few short runs in the back yard. After she regained full mobility, her protocol was reduced from daily treatments to occasional treatments as needed for pain.

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Case Presented by Pet Owner Dr. Sean Hagberg

Rio Grande Neurosciences

“Ginger, a German Shepherd, tore her ACL while playing and needed surgery. Her orthopedic surgeon loved the idea of using an Assisi Loop® post-surgically. In fact, he had the unit taped to her right after surgery. Ginger was acting like her old self within 3 days and you wouldn’t have known she’d had surgery, except for the “cone of shame.” Our vet stated that she healed in half the usual time, and she did this without any pain medication.  We were really lucky to have access to the Assisi Loops.” 

Case Presented by Pet Owner David Mazzoni

Veterinary Specialty Center, Delaware

“I treat post-op recovery patients daily and can honestly say your product made a significant difference in the amount of comfort and speed in which Bob recovered.”

Bob is a 3-year-old long-haired Chihuahua. In October 2013, he had bilateral Medial Patella Luxation (MPL) surgery – a surgery on both knee caps simultaneously to prevent them from “popping” out of place. Recovery may have seemed daunting for a little dog with two bum knees, but Bob was up and moving one day after his surgery with Dr. Scott Roberts of the Veterinary Specialty Center of Delaware (VSCD).“

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Case Presented by Dr. Tim Crowe

DVM, Lake Chatuge Animal Hospital, Young Harris

Rayne, a 15-month-old Great Dane, presented all the clinical signs of a cervical malformation – myelopathy, unable to rise without assistance, diminished proprioception and a typical “Wobbler” disease gait. The Loop was placed over her head and positioned over the affected portion of the neck. The first treatment improved coordination and she was able to rise on her own with difficulty. Her gait continued to improve with daily treatments. Rayne continues to do well at six months later. She still shows slight ataxia. Otherwise, deficits are not detectable and she runs and plays with no or very little compromise.

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Excerpt from an Interview with Dr. Stephanie Medcroft

 Small animal integrative practitioner, Maryland

“I have found the Loop to be very useful for inflammatory conditions – internal as well as external – and for wound healing. It is also a common tool in many of my chronic osteoarthritis treatment plans, especially cats, when we have so little else that can be used safely and in dogs with lumbosacral disease and pain. Because it reduces inflammation, I started using it with cats who had pancreatitis and early stages of cystitis. My own cat has had two episodes of cystitis and was blocked twice as an older cat.  This year I think I warded off an impending blockage with the Assisi Loop®.”

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Pilla, A., et al. 1996. Effect of pulsed radiofrequency therapy on edema from grades I and II ankle sprains: a placebo controlled, randomized, multi-site, double-blind clinical study. J Athl Train S31:53.

Abstract

Purpose: To determine the effect of PEMF therapy on edema volume in a ankle sprain injury. PEMF therapy was provided in a double-blind, placebo-controlled fashion, in addition to standard treatment (rest, elevation, compression, cryotherapy), for Grades I and II lateral ankle sprains. This prospective study was conducted at 14 clinical sites within the U.S.

Methods: Patients who experienced a lateral ankle sprain (Grade I or II) and could receive the first PEMF treatment within 48 hours were eligible for participation in this study. Patients enrolled were randomly divided into treatment (PEMF) and sham treatment (control) groups. Patients received a single 30 minute treatment on Day 1 and Day 2 after study entry. Swelling was measured before and after each treatment session and on Day 3. Edema volume of the injured ankle (ml) was measured by the water displacement method both before and after treatment.

Results: This study recruited 439 subjects at fourteen centers. Of this total, 395 patients completed the protocol, 193 in the control and 202 in the active groups, respectively. The difference of Day 3 to Day 1 edema volume measurements, as well as the rate of edema volume change over the same period, were evaluated for all patients, and the means for the active and control groups were compared. Edema decrease in the PEMF treated group (�]12.0±4.1 ml) was approximately 7x greater than that in the control (sham treated) group (�]1.6±3.6 ml), P=.03 (see figure 2, left). These results suggest edema was basically unchanged in the control group, whereas a significant reduction of edema volume was observed for the group exposed to PEMF therapy over the treatment and observation period. The mean rate of edema decrease (indicative of time in inflammatory phase) for this period in the PEMF treated group (�]5.8±2.1 ml/day) was nearly 5x that in the sham treated group (�]1.2±1.8 ml/day), P<0.05 (see figure 2, right). This again suggests the rate of edema change was not significantly different from zero in the control group, while a large edema decrease could be expected in the active group.

Conclusions: PEMF has a significant, additive effect on edema in ankle injury.

Kloth, et al. 1999. Effect of pulsed radio frequency stimulation on wound healing: A double-blind pilot clinical study. In: Electricity and Magnetism in Biology and Medicine, F Bersani, ed. Plenum, NY, 1999, pp. 875-878.

Abstract

Purpose: This double-blind, placebo-controlled, prospective clinical pilot study was aimed at determining the effect of pulsed radio frequency (PEMF) stimulation on the healing of chronic wounds in spinal cord injured patients. Based on other reports that invasively applied electric currents accelerate wound healing4-6, it was hypothesized that an electric current having similar parameters induced non-invasively into wound tissues by a radio frequency electromagnetic field would have a similar effect.

Methods: In this double-blind, placebo-controlled pilot study the goal was to determine the effect of PEMF treatment on healing of pressure ulcers in spinal cord injured patients. Two groups of five male patients with pressure ulcers were enrolled in the study. The ulcers of one group were treated with an active PEMF device for 30 minutes, Monday through Friday for four consecutive weeks. Ulcers of the second group were treated with a sham PEMF device for 20 days over the same time period. Both groups received a standard saline moist gauze dressing to their wounds between daily treatments. A baseline tracing of each patient’s wound opening was made and four subsequent tracings were made at weekly intervals. Tracings were digitized by computer to determine wound area dimensions in cm2.

Results: Comparison of the wound area prior to the start of PEMF treatment revealed that initial mean wound opening area was not significantly different for the PEMF sham and active groups. In contrast, after 4 weeks of PEMF therapy, wounds treated with PEMF were 64 ± 15% healed (wound closure) vs -8 ± 24%, or no change i.e., wound progression was identical to that prior to study entry, in the sham treated group, P = 0.016.

The results from this study substantiate those from a double-blind study using a similar PEMF signal on pressure ulcers in the same patient population8. Although the number of patients treated with PEMF was small, the results obtained in this pilot study suggest that RF therapy may be beneficial as an adjunct treatment for chronic wounds. Certainly the results are similar to those obtained with high voltage pulsed current4-6, with the added clinical advantage of a non-contact application and dosimetry relatively independent of the wound state.

Roland, et al. 2000. Pulsed Magnetic Energy on a Microsurgically Transferred Vessel. Plast. Reconstr. Surg 105:1371.

Abstract

This article reports the findings of a study that attempted to elucidate whether pulsed magnetic energy stimulates neovascularization in vivo, using a microsurgically created arterial loop model in a prospective randomized trial of 108 rats (n = 12/group). Pulsed magnetic energies of 0.1 and 2.0 gauss were applied immediately postoperatively and for 4, 8, and 12 weeks, respectively, with a statistically significant increase in neovascularization among the treated animals (500% increase compared with control rats. The study provides a starting point for future study and evaluation of the stimulation of angiogenesis with the use of pulsed magnetic energy and suggests a possible use of this modality to increase the quality of revascularized tissue.

Weber, et al. 2004. Experimental Pulsed Magnetic Fields Applied to a Transferred Arterial Loop Support the Rat Groin Composite Flap. (Plast. Reconstr.Surg. 114: 1185)

Abstract

Pulsed magnetic fields have been shown to stimulate neovascularization in the authors’ laboratory. The rat groin composite flap was used to create a prospective randomized trial to test the effectiveness of these pulsed magnetic fields. The skin paddle to this flap is highly consistent, and the authors proposed using the flap to study how pulsed magnetic fields affect composite flap survival when the dominant vessel to the flap is divided and flap survival becomes dependent on a transferred vessel loop. Forty-three rats had the tail artery microsurgically anastomosed to the femoral artery and placed between the groin musculature and the abdominal skin. Pulsed magnetic energy of 1 gauss was applied for 8 (n = 14) or 12 (n = 8) weeks to the experimental groups.Control groups were treated in a comparable manner for 8 (n = 16) or 12 (n = 5) weeks. After the 8 or 12 weeks, all groups had an 8 x 4-cm skin flap raised, and the superficial epigastric artery, the main feeding vessel, was ligated. After 5 days, the total area of the flap and the area of necrosis were traced onto velum paper for each rat. The percent survival was calculated per rat, and a mean survival percentage was calculated per group. The experimental animals treated with pulsed magnetic fields for 8 weeks had statistically significant improved flap survival over the control animals. The study provides evidence that pulsed magnetic energy stimulates angiogenesis and suggests a possible use of this modality to create island vascular flaps in otherwise random vascular vascular territories

Strauch, et al. Pulsed Magnetic Field Therapy Increases Tensile Strength in a Rat Achilles’ Tendon Repair Model. J Hand Surg 2006;31:1131–1135

Abstract

Purpose: To examine the effect of pulsing electromagnetic fields on the biomechanic strength of rat Achilles’ tendons at 3 weeks after transection and repair.

Methods: This noninvasive modality was tested in a prospective, randomized, double blinded, placebo-controlled study to evaluate the effect of a specific noninvasive radiofrequency pulsed electromagnetic field signal on tendon tensile strength at 21 days post transection in a rat model.

Results: In the animals receiving PMF exposure, an increase in tensile strength of up to 69% was noted at the repair site of the rat Achilles’ tendon at 3 weeks after transection and repair compared with nonstimulated control animals.

Conclusions: The application of electromagnetic fields, configured to enhance Ca2_ binding in the growth factor cascades involved in tissue healing, achieved a marked increase of tensile strength at the repair site in this animal model. If similar effects occur in humans, rehabilitation could begin earlier and the risk of developing adhesions or rupturing the tendon in the early postoperative period could be reduced.

Patel, M. el al. 2006. Limited Myocardial Muscle Necrosis Model Allowing for Evaluation of Angiogenic Treatment Modalities. Journal of Reconstructive Microsurgery, 22, 611

Abstract

The currently accepted model for creating infarcted cardiac tissue in a rat model involves ligation of the left anterior descending artery (LAD), either proximally or at the bifurcation level. This procedure requires significant technical expertise and, even in skilled hands, commonly results in a 30 percent to 60 percent animal mortality. The authors propose a new model for creating a limited area of myocardial muscle necrosis that can be effectively studied. It involves a distal electrocautery occlusion of the LAD terminal branches and coagulation of the surrounding muscle. The model is consistently reproducible and decreases the morbidity of the study animals. It provides a cardiac muscle necrosis model not dependent on survival, while allowing study of the post injured state of the muscle and surrounding scar. This allows researchers to evaluate neovascularization and healing of the scar and peri-necrotic muscle, to assess improving blood flow with treatment by techniques designed to improve and stimulate angiogenesis, and to measure the outcome of stem-cell transplants for potential clinical use.

Strauch, et al. 2007. Pulsed Magnetic Fields Accelerate Cutaneous Wound Healing in Rats. Plast. Reconstr. Surg. 120: 425.

Abstract

Background: Previous studies of pulsed magnetic fields have reported enhanced fracture and chronic wound healing, endothelial cell growth, and angiogenesis. This study characterizes the biomechanical changes that occur when standard cutaneous wounds are exposed to radiofrequency pulsed magnetic fields with specific dosage parameters, in an attempt to determine whether return to functional tensile strength could be accelerated in wound healing.

Methods: There were two study phases and a total of 100 rats. In phase 1, wounds were exposed to a 1.0-G pulsed magnetic field signal in clinical use for wound repair for 30 minutes twice daily for 21 or 60 days. Phase 2 was a prospective, placebo-controlled, double-blind trial in which rats were treated for 30 minutes twice daily with three different low-amplitude signals (0.02 to 0.05 G), configured assuming a Ca2_ binding transduction pathway, for 21 days. A midline, 8-cm, linear skin incision was made on the rat dorsum. Tensile strength was determined by measuring the point of rupture of the wound on a standard tensiometer loaded at 0.45 mm/second. Results: The mean tensile strength of treated groups in phase 1 was 48 percent (p = .001) greater than that of controls at 21 days; there was no significant difference at 60 days. In phase 2, the treated groups showed 18 percent (not significant), 44 percent, and 59 percent (p_0.001) increases in tensile strength over controls at 21 days.

Conclusion: The authors successfully demonstrated that exposing wounds to pulsed magnetic fields of very specific configurations accelerated early wound healing in this animal model, as evidenced by significantly increased wound tensile strength

Casper, D, et al. 2008. Pulsed Electromagnetic Fields Modulate cyclic GMP via a Nitric Oxide-Dependent manner in a Dopaminergic Neuronal Cell Line. Society for Neuroscience.

Abstract

There is currently no neuroprotective treatment for Parkinson’s disease, where dopaminergic neurons in the substantia nigra degenerate. Experimental evidence provides several mechanisms by which neuronal survival might be increased that include; neurotrophic factor induction, calcium ion/protein interactions, and signal cascades initiated or regulated by nitric oxide (NO). Because these mechanisms of neuro-protection overlap with known actions of pulsed electromagnetic fields (PEMF), we are currently testing the potential of PEMF signals to influence neuroprotective pathways. Using a cell line of rodent dopaminergic neurons, we tested the effects of specific PEMF signals that were configured to enhance Ca2+ binding to calmodulin (Ca/CaM). We predicted this would activate Ca/CaM-dependent nitric oxide synthase (NOS), which in turn would modulate NO-sensitive guanylate cyclase (GC) to increase levels of cyclic GMP (cGMP). Experiments were performed using the dopaminergic MN9D cell line. Medium containing DMEM and 10% serum was changed to DMEM alone prior to PEMF treatment. Inhibitors of Ca/CaM (W-7), NOS (L-NAME), GC (ODQ), and PDE1 (8MM-IBMX) and vehicles were added when the medium was changed. PEMF signals consisting of 5 msec bursts of 27.12 MHz sinusoidal waves repeating at 5 bursts/sec, at 0.05 Gauss peak amplitude,configured a priori to modulate calcium binding to calmodulin were administered over 30 minutes. Control cultures were subjected to “null” signals under identical conditions. Conditioned media and cell lysates were collected at various times after PEMF treatment. NO was quantified indirectly by measuring NO2 with the Griess assay. Cyclic GMP was quantified by ELISA. NO2 concentrations in conditioned media increased from 0 to 1 micromolar over 5 hours. Cultures exposed to PEMF exhibited an accelerated increase in NO2 concentrations within the first 2 hours after treatment. Cyclic GMP synthesis increased up to 3-fold after PEMF treatment over the course of 5 hours. This effect was blocked by L-NAME, indicating that PEMF-induced cGMP production was dependent on NO synthesis. The PDE1 inhibitor 8MM-IBMX increased cGMP levels in both control and PEMF-treated cultures. Taken together, resultssuggest that PEMF signals can exert biological effects within neurons via Ca/CaM-dependent enzyme activation. Because alterations in both NO and cGMP levels can influence neuronal survival, future experiments will address more downstream events in the PEMF signal transduction cascade.

Casper, D. 2008. PEMF potentiates the Induction of Nitric Oxide by Glutamate and 6-Hydroxydopamine in a Neuronal Cell Line. Bioelectomagnetic Society Meetings June, Davos, Switzerland.

Abstract

Introduction: Nitric oxide (NO) is essential for neuronal viability, but it can also be toxic in high concentrations. Generally, neuronal nitric oxide synthase (nNOS) produces NO that participates in survival signaling pathways. During inflammation, inducible NOS (iNOS) produces 10-fold greater amounts, resulting in toxicity. Using a cell line of rodent dopaminergic neurons, we used glutamic acid, a neurotransmitter and excitotoxin, and 6-hydroxydopamine (6-OHDA), an oxidative stressor, to model the initiating events of the neurodegenerative process. Both of these insults cause a transient increase in cytosolic free Ca2+, which activates resting calmodulin (CaM), a calcium binding protein. This is known to rapidly activate the Ca2+-dependent NO cascade as the body attempts to control inflammation. In this study we tested the effects of specific PEMF signals configured to enhance Ca2+ binding to calmodulin (Ca/CaM) to activate the synthesis of NO in the presence of both neurotoxins.

Materials And Methods: N9D, a rodent dopaminergic hybrid cell line, was provided by Dr. Alfred Heller at the University of Chicago. Cells were dissociated, plated in 35 mm culture dishes, and allowed to attach for at least 24 hours before treatment. For experiments, cultures were equilibrated in Krebs buffer for 10 minutes, after which 30 μM 6-OHDA, 100 μM glutamic acid, or buffer alone were added. A PEMF signal, configured a priori to accelerate the kinetics of Ca2+ binding to CaM, and consisting of 5 msec bursts of 27.12 MHz sinusoidal waves at 5 bursts/sec and 0.05 Gauss peak amplitude, was administered beginning two minutes prior to the addition of toxin. Control cultures were subjected to “null” signals under identical conditions. NO levels were measured by an electrochemical detection system (WPI) in real time from equilibration in Krebs buffer until the effects of the added toxins or buffer were no longer detectible. NOS inhibitors were added at least 30 minutes prior to toxins and PEMF signals. NO levels were calculated from the maximum change in current induced by toxin ± PEMF treatment minus the values obtained by adding buffer alone. Data were compared by ANOVA and Fischer’s PLSD post-hoc tests. Results: The selective dopaminergic neurotoxin 6-OHDA produced a rapid 500 nM increase in NO within 10 seconds. NO production decayed over 2 minutes, returning to baseline levels. When PEMF signals were applied to culture dishes prior to and during the addition of toxin, this increase was potentiated more than 200%, with measured NO concentrations of 900 nM. To confirm that this increase was due to NO synthesis, treatments were repeated in the presence of 3.3 mM L-NAME, a non-selective NOS inhibitor. Results indicate that LNAME diminished NO levels to 33% of cultures treated with 6-OHDA alone, and to 24% of NO levels induced by 6-OHDA + PEMF. Similar results were obtained in the presence of glutamate, an established endogenous neurotransmitter that acts on dopaminergic neurons through both ionotropic and metabotropic receptors. With this stimulant, the increase in NO production was lower in magnitude, increasing NO levels less than 100 nM. PEMF signals potentiated this increase by133%. Neither 6-OHDA nor glutamate were toxic over this time course. Conclusions: Our results demonstrate very rapid and transient effects of PEMF signals on NO synthesis in a neuronal cell line in two models of dopaminergic cells death. While higher concentrations of toxins and longer incubations may result in toxicity, the effects observed here are immediate early events in response to toxic challenge. While 6-OHDA causes oxidative stress, there is also an inflammatory response to this compound in vivo and in vitro that may be inherent to dopaminergic neurons themselves even in the absence of other cell types. In contrast, glutamate-mediated cell death involves the influx of calcium ions through receptor ion channels. Importantly, relatively low-level increases in NO production have been shown to initiate neuroprotective signaling cascades that could increase resistance to both of these insults. Experiments to distinguish the role of inflammatory events and calcium influx in the mechanism by which PEMF affects NO signaling are in progress.