RESTORATION of NEUROLOGICAL and CELL SIGNALLING

Becker showed the importance of voltage and polarity in neurological function and regeneration. Most electrotherapy devices deliver low voltage with constant current and do not allow any control over voltage or polarity. DynaWave technology offers total clinical control over both voltage and polarity.

A rapid rise time of the high voltage pulse is critical for charging the cell’s lipid bilayer membrane, to efficiently modifying cell membrane voltage. Let’s look at the effects of just changing the membrane voltage in the post synaptic neuron:

• Hyperpolarizing the neuron acts similar to an inhibitory neurotransmitter; it makes the nerve less responsive and the generation of nerve impulses more difficult.
• Positive Polarity – acts like an inhibitory neurotransmitter, hyperpolarizes postsynaptic neuron

• Depolarizing the neuron acts similar to an excitatory neurotransmitter; it brings the membrane potential closer to threshold and makes it more responsive.
• Negative Polarity –acts like an excitatory neurotransmitter, depolarizes postsynaptic neuron

Gavrilov, showed that ultrasound is capable of activating both superficial and deep peripheral nerves in humans.  Using precisely modulated ultrasound produces transient changes in lipid bilayer tension, effecting mechanosensitive properties in voltage-gated ion channels, as well as neurotransmitter receptors; changing both gating kinetics to calcium and synaptic efficiency.  

 Hyperpolarizing or depolarizing cell membranes selectively opens or closes voltage-gated channels, adjusting cytosolic calcium. Since calcium and the electrical state of the cell play a major role in its reaction to signaling, these changes can modify the cell’s response to both electrical and chemical messengers.

Adjusting cytosolic calcium - new opportunities for therapeutic effects.

• Calcium acts as a primary messenger in cell signaling, and since it is an important secondary messenger in ligand-gated signaling, it even affects the cellular response to hormones.
• Calcium is critical for the release of bound ATP and upregulating cell function. It initiates cell functions as diverse as endocytosis (the removal of oxidized cross linked proteins in the cell which contribute to cellular aging and disrupt mitochondrial function) to apoptosis (or the naturally programmed cell death that protects cells from cancer). 
• Calcium plays a regulatory role in inducing NO nitric oxide (or endothelial relaxing factor); explaining the hours of vasodilation and blood flow from just minutes of pulsed voltage

McCaig and Rajnicek have shown that pulsed negative polarity stimulates nerve growth and neurological regeneration; while Muorad, demonstrated nerve regeneration with 2.25 MHz ultrasound. The ability to adjust membrane voltage, polarize or depolarize cell membranes, open or close voltage-gated channels and modify cytosolic calcium makes the SmartSound clinically effective for neuromodulation.

Bikson, showed that low energy pulses on isolated neurons can lead to significant changes in network dynamics through nonlinear amplification mechanisms. The induction of plastic changes in neurological signaling underlies the persistent effects observed after repeated treatment with pulsed ultrasound and pulsed voltage.

DECUBITUS ULCER

In nursing homes and residential care facilities nationwide, the incidence of bedsores is estimated to be up to 23%. The agency for Healthcare Research and Quality estimates the prevalence of pressure ulcer to be up to 28% in long-term care. Center Medicaid Services (CMS) estimates the cost of treating a pressure ulcer in acute care to be $43,180. Stage IV ulcer is particularly costly to treat; NIH estimates the cost of treating a Stage IV pressure ulcer to be up to $129,248. The overall annual cost for the treatment of  pressure ulcers has been estimated to be between 5 billion and 8.5 billion dollars. 

Since this is considered a preventable and treatable condition, the presence of an ulcer is considered evidence of substandard care. This can create significant financial and legal issues for hospitals and nursing homes. 

Felony charges of involuntary manslaughter and neglect were filed against a Missouri residential care facility when a resident died of bedsores. Court records show that in nearly 87% of the cases the jury awarded substantial compensation to the plaintiffs.

Even in states that limit monetary awards, punitive damages can be in the millions.

• ·        In California, a jury awarded in Ollison v. Eskaton, $3 million in damages against a nursing home for allowing an elderly woman to die of bedsores (Sacramento Superior Court).

• ·        In Texas, $324,000,000 was awarded with an additional $300 million in punitive damages for the death of elderly patient due to malnourishment and infected decubitus ulcers.

Specific risk factors for pressure ulcer development

• More than 70 years of age
• Poor nutritional status
• Prolonged periods of immobilization
• Incontinence
• Uncontrolled diabetes
• Circulatory problems
• Fractures

Mechanisms for Ulcer 

Today there seems to be a unifying hypothesis of chronic wound pathogenesis based on four main causative factors:

• ·        bacterial colonization of the wound

• ·        local tissue hypoxia

• ·        repetitive ischemia-reperfusion injury

• ·        altered cellular and systemic stress response in the aged patient

While the standard of care is to rotate patients every 2 hours, the unsafe restoration of blood flow to ischemic tissue can cause more damage. This ischemia-reperfusion injury is often encountered in surgical practice this can cause a pressure sore to occur, enlarge, or become chronic. 

This ischemia-reperfusion injury occurs, for example, when a paraplegic or quadriplegic patient is turned from one side to the other, in a well-intentioned attempt to combat prolonged pressure on a given side. 

The reperfusion of hypoxic ischemic tissues with oxygen rich blood results in the formation of toxic Reactive Oxygen Species (ROS), including:

• ·        superoxide anions (O²−),

• ·        hydroxyl radicals (OH−),

• ·        hydrogen peroxide (H²O²

• ·        peroxynitrite

These reactive oxygen species attack cell membrane lipids, proteins, and glycosaminoglycans, causing extensive damage to tissue. So, turning patients every 2 hours can create both local and remote tissue destruction and sometimes even death. Therefore the safe reperfusion of the ischemic area at risk remains the cornerstone of clinical care for decubitus ulcer.

SmartSound technology, in a placebo controlled trial healed Stage IV diabetic ulcer. It has been shown to be unmatched in wound care. The researchers proclaimed, "the total healing of chronic wounds" in less than 8 weeks. Demonstrating a 100% healing rate in Stage 1V ulcer.


Decubitus Ulcer

Strength of Evidence A 

Medical Necessity Mandates Use

This is the most researched and clinically effective form of electrotherapy; it has been given an (A) strength of evidence rating. Medical necessity mandates its use when an ulcer has not healed for thirty days. Kloth and others showed that you could promote healing and prevent amputation even in elderly diabetics with Stage 4, non-responsive ulcer.

Electrotherapy has been shown to control infection, stimulate fibroblast activity and heal Stage 4 diabetic ulcer. Also, therapeutic ultrasound has been shown to accelerate the early phase of wound healing, promote wound closure, and epithelialization. Recent clinical research has suggested the LED photon therapy can help prevent diabetic ulcer and stimulate healing.

The biotechnology and pharmaceutical industries have directed considerable effort toward developing novel therapeutic strategies to limit or prevent Ischemia-reperfusion injury through using NO (nitric oxide). Nitric oxide acts as a vasodilator and it  has been shown to have a protective effect on even the heart, kidney and brain, providing a safe treatment for ischemia.

• Properly modulated ultrasound induces endothelial cells to release nitric oxide, safely restoring circulation in ischemic limbs. 

• Pulsed voltage acts as a vasodilator by inducing nitric oxide and has been shown to be effective in treating both ischemic wounds and diabetic ulcer. In controlled studies, DynaWave pulsed voltage has been shown to provide a 100% healing of stage IV ulcer in less than 8 weeks and help control infection.

• The synergistic combining of pulsed voltage and pulsed ultrasound provides results that are unavailable when used separately. 

• Inducing Nitric Oxide Synthase helps to safely restore circulation to ischemic tissue to prevent and heal ulcer.

The CRISIS of DIABETES

Diabetes is one of the fastest growing health crises. According to a recent JAMA article, “for individuals born after 1999 the estimated lifetime risk for developing diabetes is now up to 32.8% for males and 38.5% for females”. With the highest estimated lifetime risk for diabetes (up to 52.5%) in Black, American Indian, Indian and Hispanic females.

The direct and indirect cost of diabetes places an enormous burden on the health care system.

• Regarding institutional care, diabetics represent 22% of all hospital inpatient days.
• According to ADA, diabetic outpatient care represented 14% of physician office visits.

The American Diabetes Association estimates in the United States almost 50% of the cost of care is spent on hospitalization to treat diabetic complications.

Researchers estimate that the nation could easily save $2.5 billion a year by preventing diabetes complications. Complications like neuropathy and foot ulcer are common in diabetics. Foot ulcer is less common, yet still effects up to 15% of diabetics.

Also, the rate of foot ulcers have been increasing. Data from NHDS (National Hospital Discharge Surveys) showed that the rate of foot ulcers increased almost 50% between 1983 and 1990. 

Center Medicaid Services (CMS) estimates the cost of treating a pressure ulcer in acute care to be $43,180. Stage IV ulcer is particularly costly to treat; NIH estimates the cost of treating a Stage IV pressure ulcer to be up to $129,248. 

SmartSound technology, in a placebo controlled trial, healed Stage IV diabetic ulcers. It has been shown to be unmatched in "wound care". The researchers proved, "the total healing of chronic wounds" in less than 8 weeks. Demonstrating a 100% healing rate in Stage 1V ulcer.

Diabetic and Decubitus Ulcer

Strength of Evidence A 

Medical Necessity Mandates Use

Electrotherapy has been shown to promote healing and to prevent amputation even in patients with a Stage 4, non-responsive diabetic ulcer. Medical necessity mandates the use of high volt pulsed current (HVPC) when a diabetic ulcer has not healed for thirty days. This is the most researched and clinically effective form of electrotherapy and it has been given an (A) strength of evidence rating. It has been shown to control infection, stimulate fibroblast activity and heal Stage 4 diabetic ulcers. Also, therapeutic ultrasound has been shown to accelerate the early phase of wound healing, promote wound closure, and epithelialization. Recent clinical research has suggested the LED photon therapy can help prevent diabetic ulcers and stimulate healing.

Decision Memo for Electrostimulation for Wounds (CAG-00068N)

"Based on all of the evidence that we have reviewed in this matter, it is our intention to issue a positive coverage decision only on the use of electrical stimulation for chronic Stage III and Stage IV pressure ulcers, arterial ulcers, diabetic ulcers and venous stasis ulcers. Chronic ulcers are defined as ulcers that have not healed within 30 days of occurrence. The use of electrical stimulation will be covered as adjunctive therapy only after there are no measurable signs of healing for at least 30-days of treatment with standard wound therapy and must be used in addition to standard wound care."

Diabetic Neuropathy

Strength of Evidence B

Medical Groups Mandates Use In

Electrotherapy has a long history of use in controlling pain and has been shown to be effective in relieving the pain of diabetic neuropathy. In a controlled study of electrotherapy and amitriptyline published in Diabetes Care:

•             Medication reduced pain 26% 

•             Electrotherapy reduced pain 56%.

•             Electrotherapy seemed to control pain 215% better, even in patients unresponsive to medication 

Also, therapeutic ultrasound has been shown to reduce pain and promote healing in neurological conditions. It has also been shown to stimulate: nerve sprouting, regeneration, myelination, increased Schwann cell nuclei, and neural tube repair. Muorad, used a 2.25 MHz ultrasound and demonstrated regeneration of the sciatic nerve in compression injury. And ultrasound has been shown to be beneficial in treating carpal tunnel syndrome. Recent research has suggested that LED photon therapy may help to treat diabetic neuropathy and reverse sensory loss. 

Poor circulation contributes to neuropathy to foot ulcers and other complications in diabetics. Clinical research has shown that pulsed voltage can enhance blood flow and oxygen delivery to diabetic wounds; even in patients with poor circulation. 

Simultaneously pulsing ultrasound and voltage together acts as a potent vasodilator, due to the release of Nitric Oxide. Diabetics seem to have some loss of Nitric Oxide induced vasodilation. Pulsed ultrasound stimulates endothelial cells to induce Nitric Oxide and release intracellular Ca². The pulsed voltage opens inward Ca² voltage gated channels to increase Nitric Oxide Synthase expression. 

CONTRAINDICATIONS, PRECAUTIONS, and WARNINGS

Electrical and ultrasound stimulation can mask pain, impairing detection and diagnosis of disease.  Careful evaluation by a physician and/or therapist should precede the use of any electrical stimulation or ultrasound device. 

1. The safety of electrical stimulation has not been established for use during menstruation or during pregnancy, labor and delivery. Ultrasound should never be used on the pelvis, abdomen and lumbar (lower back) region in pregnant or potentially pregnant females.
2. Do not use around the heart, particularly patients who have demand type cardiac pacemaker. Adequate protection should be taken in the care of a person with suspected heart problems. Patients suffering from cardiac disease should not receive treatment over the cervical ganglia, the stellate ganglion, the thorax in the region of the heart, or the vagus nerve, as a reflex coronary vasospasm might result. Only low intensities and short treatment times should be used if these patients are treated in other areas since the stimulation of practically any afferent autonomic nerve (especially the vagus nerve) in the body may cause a change in cardiac rate. Do not use ultrasound over blood vessels in poor condition as the vessel walls may rupture as a result of the exposure.
3. Do not stimulate over the carotid sinus nerves, especially in patients with a known sensitivity to the carotid sinus reflex. Severe spasm of the laryngeal and pharyngeal muscles may occur when electrodes are positioned over the throat or the mouth.  The contractions may be strong enough to close airways or cause difficulty in breathing. Do not use ultrasound on the front of the upper neck (thyroid region)
4. Do not use electrical stimulation transcerebrally, along regions of the phrenic nerve or over laryngeal muscle. Do not use ultrasound over highly ultrasound-sensitive organs eyes and ears or over mucous membranes (mouth, nose, rectum/anus, vagina)
5. Do not use electrical stimulation over infection (osteomyelitis etc.) or wound with hemorrhage. Do not use ultrasound over areas suspected to be cancerous or pre-cancerous. Ultrasound treatment of acute infection of bone or tissue could force areas of pus into surrounding tissue, thereby spreading infection.
6. Do not use ultrasound on patients with spina bifida or surgical laminectomies of the spine or de-sensitized areas of the skin (eg. diabetic neuropathy) or over cortisone injections within 30 days.
7.  Do not use ultrasound over sensitive organs such as ovaries, testicles, brain, spinal cord, heart, or kidneys
8. Do not use ultrasound on patients with phlebitis, deep venous thrombosis or hemophilia. Patients with thrombophlebitis or other potentially thromboembolic diseases should not be treated since a partially disintegrated clot could result in an obstruction of the arterial supply to the brain, heart or lungs.
9. Adequate protection should be taken in the care of a person with suspected or diagnosed epilepsy.
10. Always turn the stimulation device off before applying or removing electrodes. If irritation develops at electrodes sites, discontinue use of those sites.

Operator Safety – The operator of ultrasound therapy devices should minimize exposure to themselves as follows:

The applicator face must not be touched by the operator when the device is emitting ultrasound. The operator should hold it firmly by the rubberized grip. 

Patient Safety

Ultrasound therapy devices should only be turned on when the operator is holding the soundhead by the handle.

Since ultrasound is almost totally reflected at an air-tissue interface, coupling media must always be used between the applicator surface and the patient. Never use ultrasound unit for treatment without using the conductive gel.  The face of the applicator must be in acceptable acoustic contact with the patient.

The transducer should be kept moving slowly, angled at 90° to the treatment area, during the course of treatment to minimize the risk of causing hot spots and tissue damage. Another reason to avoid the use of a stationary transducer, prolonged standing waves might result in blood flow arrest and cause possible damage to the endothelial cells in the blood vessel walls. This could also lead to the formation of blood clots.

To minimize potential adverse health effects, the operator should use the minimum patient exposure required to achieve the desired benefit.

Records should be kept of each patient, noting the exposure levels, times, and couplant used. Maintaining well documented, reproducible records help to minimize unnecessary exposure.

Thermal Applications - If any pain or uncomfortable "prickly" sensation is felt by the patient, this may be an indication that the bones or nerve endings in the vicinity of the ultrasonic beam are becoming, or are already, overheated. In this case the ultrasound power or intensity must be immediately reduced.