Document:

BioElectronics Corporation: Exhibit 10.14 - Prepared by TNT Filings Inc.

 

Exhibit 10.14 

The Physics and 

Clinical Research 

Behind ActiPatchTM 

 

 

 

 

BioElectronics Corporation 

401 Rosemont Avenue, Rosenstock Hall, 3rd Floor, Frederick, Maryland
21701 

Phone: 301-644-3609     Fax: 301-644-3939    
Email: info@bioelectronicscorp.com 

Website: bioelectronicscorp.com     OTC: BBPK BIEL 

	 	 
	
    Table of Contents

	 	 
	Summary	4
	 	 
	History of Pulsed Electromagnetic Therapy	4
	 	 
	Effective Low Cost Therapy	6
	 	 
	Technological and Clinical Evidence of
    Effectiveness	7
	 	 
	How ActiPatch Works	7
	 	 
	Superior Extended Dosage	8
	 	 
	Confirming Low Power and Extended
    Treatment Duration Clinical Studies	11
	 	 
	Wound Studies	12
	
    Direct Comparison of Standard PEMF Device and a
    Low Power Prototype ActiPatch,
	12
	
    Effect of a 15-Watt Pulsed 27.12 MHz and a 2mW
    pulsed 3 MHz device on the tensile strength of rat
	 
	
    abdominal wounds,
	12
	
    Human Experimental Wounds, Bentall, RHC 1981
	15
	
    A Portable Pulsed EMF (PEMF) Device To Enhance
    Healing Of Recalcitrant Venous Ulcers: A Double- Blind, Placebo-Controlled
    Clinical Trial.
	16
	
    Effect of low frequency pulsing
    EMFs on skin ulcers of venous origin in humans: a double-blind study.
	17
	
    The treatment of pressure sores using pulsed
    electromagnet energy (PEME)
	17
	
    Photographic Evidence of Clinical Effectiveness –
	18
	
    Sacral Decubitus Ulcer
	18
	
    Low Pulsed Electromagnetic Therapy (ActiPatchTM)
    as a Useful and Effective Adjunct for the Healing of Recalcitrant Wounds,
    Tracey C. Vlahovic, DPM
	19
	Plastic Surgery Clinical Studies	24
	
    Blepharoplasty Pilot Study, Bentall, RHC 1982
	24
	
    1984/5 Blepharoplasty Study (Bentall, Bentall and
    Nicolle, 1985)
	25
	
    Analysis of Blepharoplasty Results
	33
	Published Plastic Surgery Articles	34
	
    Pulsed Electromagnetic Field Therapy In Plastic
    Surgery, Brian M. Kinney, MD, FACS, MSME Aesthetic Plastic Surgery,
    January/February 2005 • Volume 25 • Number 1
	40
	
    ActiPatch Therapy Following Cosmetic Surgery of
    the Face and Neck: A Valuable Adjunct to the Postoperative Management, Casas,
    Laurie A., MD FACS
	45

2

	 	 
	
    The Effects of Actipatch Therapy Following
    Cosmetic Face and Neck Procedures: An Observational Study, Casas, Laurie A.,
    MD FACS
	46
	
    ActiPatch Pain Control Device, Kimberley B.C. Goh,
    M.D.
	51
	Podiatric Clinical
    Studies	52
	
    Achilles Tendon Pain Management with ActiPatch,
    James C. Ricketti, D.P.M.
	53
	
    Plantar Fasciitis Pain Management with ActiPatch,
    James C. Ricketti, D.P.M.
	54
	
    Acute Gout Pain Management with ActiPatch
    Therapy, John Franceschini, D. P. M.
	55
	Orthopedics	56
	
    Professional Sports Teams Using ActiPatch
	56
	
    Pulsed High Frequency (27 MHz) Electromagnetic
    Therapy For Persistent Neck Pain, A Double Blind, Placebo-Controlled Study
    Of 20 Patients
	56
	
    Low Energy High Frequency Pulsed Electromagnetic
    Therapy For Acute Whiplash Injuries. A Double Blind Randomized Controlled
    Study
	56
	
    Treatment of Supraspinatus Tendonitis and Lateral
    Epicondylitis
	57
	
    with ActiPatch Therapy, Dr. Michael Brady, D.C
	57
	Dermatology	57
	
    Therapeutic Effect Of A Very Low Powered Herzian
    Wave Transmissions,
	57
	Conclusion	58
	 	 
	Clinical
    References: Low Power 27 MHz Clinical Studies	58
	 	 
	Clinical
    References: Other Pulsed Electromagnetic Therapy Studies	58

3

Summary 

ActiPatchTM is a drug-free, anti inflammatory patch that is proven safe,
low-cost and easy to use by doctors and patients alike. ActiPatch uses an
imbedded microchip and battery that delivers an effective dosage of energy from
a low-power pulsed electromagnetic field [PEMF]. The result is a significant
acceleration in the recovery of the body's injured soft tissue. The medical
literature documents that PEMF has been used extensively for decades by
physicians around the world to for a wide variety of tissue injuries including
sports injuries [sprains and strains], bone fractures, post-surgical care and
chronic wounds. 

This paper describes the physics of ActiPatch and a sampling of the clinical
data in support of its applications. We will cover the following topics: 

  1. Review the history and the evidence for the efficacy of pulsed
  electromagnetic field therapy. 

  2. Substantiate how the miniaturized, low-power ActiPatch
  delivers: 

  
    a. Equivalent instantaneous therapy to predicate, high-power
    PEMF machines, 

    b. Superior extended duration dosage; and 

    c. A therapeutic dosage, 6 to 9 orders of magnitude greater
    than required to achieve a biological effect. 

  

  3. Describe specific clinical studies demonstrating the
  efficacy of extended duration, low-power PEMF therapy. 

  4. Provide photo documentation of PEMF on soft tissue
  injuries. 

  5. Review Clinical Studies by medical specialty. 

History of Pulsed Electromagnetic Therapy 

The studies of the electric current in the body and the
potential of using various forms of electrical current to promote healing are
centuries old. In 1791, Luigi Galvani demonstrated that he could cause a frog's
leg muscle to contract by applying an electric current. It was more than 170
years ago that Carlos Matteucci proved that injured tissues generate an electric
current. i Dubois-Reymond, 1843, measured 1 microampere of current in
a wound of human skin. 

1934 – Ginsberg pulsed the transmission of a medical diathermy
to elicit a non-thermal biological effect. Since this pioneering work, PEMF
therapeutic applications have been reported for the reduction of post-traumatic
and post-operative pain and edema in soft tissues, wound healing, burn
treatment, and nerve regeneration. 

There has been a considerable acceleration of research activity
over the past 25 years. Interest was stimulated following reports of bioelectric
fields being associated with amphibian limb regeneration and bone mechanics. 

Much of the initial work, particularly in the orthopedic
applications, was performed using direct current, pulsed direct current or
alternative current. More recently, similar effects on bone healing have been
demonstrated using pulsed electromagnetic fields. 

4

1960 – Dr. Reinhold Voll, of Germany invented Dermatron a device for
outputting micro current electrical stimulation of human tissue. It was noted by
Cameron (1961) that pulsed radio frequency treatment of a surgical incision in
the dog resulted in less severe edema then in the untreated controls. If pulsed
electromagnetic energy reduces edema and so accelerates the acute inflammatory
phase of wound healing, it should also enhance the second and third phases. 

1969 – Wolcott, et al. applied electrical stimulation in the range of 200-800
microamps to a variety of wounds. Treated wounds showed 200-500% faster healing
rates with stronger tensile strength of scar tissue and antibacterial effects on
infected wounds than the control group. 

1975-1976 – Gault and Gatens used a similar procedure on a range of disease
states and showed a 50% improvement in healing rates over the control groups.

Pulsed electromagnetic therapy is approved by the US FDA and to date, has
been used on 500,000 patients in the United States for non-fusion bone growth
stimulation. 

1982 – Dr. Bentall, a surgeon, and Timothy Cox, D. Phil., an electrical
engineer, developed the Portic Electronic Bandage, the first miniaturized pulsed
electromagnetic device. The device and subsequent clinical studies on over 2000
subjects established the clinical effectiveness of low power pulsed
electromagnetic energy using a 3-volt lithium battery. 

1991- The existence and importance of small electrical charges in the
membrane of all cells was firmly established in 1991 when the Nobel Prize in
Physiology or Medicine was awarded to two German cell physiologists, Erwin Neher
and Bert Sakmann, for their discoveries concerning "the function of
single ion channels in cells." Neher and Sakmann measured the incredibly small
electrical charge of the cell membrane. The membrane separates the world within
the cell from its exterior and surrounds each living cell. In this membrane
there are channels through which the cell communicates with its surroundings.
These channels consist of single molecules or complexes of molecules and have
the ability to allow passage of ions. The regulation of ion channels influences
the life of the cell and its functions under normal and pathological conditions.

2000 - The New Technology Committee of the American Society
of Aesthetic Plastic Surgeons evaluated and approved PEMF treatments for edema
reduction, accelerated healing and post operative surgical pain. 

2002 – U.S. FDA approves low dose, extended duration ActiPatch Therapy for
the treatment of edema following blepharoplasty. 

2004 – European Common Market approves low dose ActiPatch
Therapy as a Class II medical device, allowing sales without a prescription, for
all pulsed electromagnetic therapy indications and retail sales. 

2004 - US Medicare and Medicaid agree to reimburse for electromagnetic
treatment of chronic Stage III and IV wounds. 

5

2005 – Dr. Debra Niehoff publishes "The Language of Life, How Cells
Communicate in Health and Disease" explaining cellular communication and
supporting a low dose therapy mechanism of operation. 

2005 – Health Canada approves ActiPatch Therapy for "relief of pain in
musculoskeletal complaints." 

Additional ongoing research on the therapeutic benefits of pulsed
electromagnetic therapy is being conducted at the Bioelectromagnetics
Laboratories, New York State University, Temple, Northwestern University,
Wisconsin University, Stanford, MIT, Yale and other distinguished research
centers. 

Effective Low Cost Therapy 

It is now widely accepted within orthopedics, sports and physical medicine,
plastic surgery, and chronic wound care that weak, non-ionizing electromagnetic
fields exert a wide range of beneficial effects. With the advent of inexpensive,
self-administered micro-technology, other branches of medicine are recognizing
and utilizing the curative benefits of PEMF therapy. Many of the athermal
bio-responses, at the cellular and sub-cellular levels, have been identified and
found appropriate to correct or modify the pathologic processes for which pulsed
electromagnetic therapy ("PEMF") is now being used. 

The unique product distinction and deliverability of PEMF is accelerated
healing, that is:

	Easy to use;
	Inexpensive;
	Drug free and;
	Therapeutically beneficial, unlike TENS units or pain patches that only
  mask the pain.

The following is a list of diagnoses which clinicians have had success in
reducing edema and treating pain to accelerate healing with pulsed
electromagnetic energy: 

	Post -Surgical	Orthopedic
    Conditions
	Post Operative Knee
    Repair	Ankle Sprains
	Repair of Ankle
    Fracture	Lower Back Pain
	Abdominoplasty	Tennis elbow
	Rhytidectomy	Carpal Tunnel
	Breast Augmentation	Frozen Shoulder
	Liposculpture	Tendonitis
	Blepharoplasty	Heel Pain
	Rhinoplasty	 
	 	Podiatric
    Conditions
	Chronic Wounds	Plantar Fasciitis
	Diabetic Foot Ulcers	Achilles Tendonitis
	Decubitus Ulcers	Tarsal Tunnel Syndrome
	Venous Leg Ulcers	Gout

There is no "competitive technology" to ActiPatch for effective, low-cost,
adjunctive wound care. 

6

Technological and Clinical Evidence of Effectiveness 

When the body receives an injury during surgery, or from trauma such as a
sprain, the danger of infection is low. Nevertheless, the body will react to the
injury to prevent an infection. This response is known as the "inflammatory
process" and consists of a rapid onset tissue destruction phase followed by a
longer duration tissue repair phase. The initial destruction phase is evidenced
by redness, heat, swelling and pain in the tissue. To enhance the healing of
non-infected injuries, the therapeutic goal of the ActiPatch Therapy products is
to induce the tissue to rapidly pass through, or by-pass, the tissue-damaging
phase of the inflammatory process and move to the tissue repair phase. 

    Inflamed Injured-Tissue 

	
    Normal cells manage the
    functions of the body by acting in groups at the system or population level.
    The actions of those cell populations are very dependent on the
    communication channels among the cells to create synchronization. 
    
	
    
    
    

	
    
    
    
	
    Wounded Skin Cells With Edema
    -- You can see how the cells have been pushed apart into a chaotic pattern
    with interstitial fluid interrupting the normal synchronized cellular
    communication. 

How ActiPatch Works 

ActiPatch facilitates the healing of injured tissue by this effective
delivery of pulsed electromagnetic energy directly into the site of injury
following surgery or other trauma.

	Electromagnetic pulsed therapy causes demonstrated reduction in the
  swelling ("edema") and inflammation that occur during acute and chronic injury
  to tissue.
	The treatment provides improved microvascular perfusion of the damaged
  tissue. The result is faster clearing of edema fluid, and faster elimination
  of many of the noxious agents that are released into tissue following an
  injury.
	These mechanisms safely provide an environment in which there is a well
  demonstrated and significant improvement in the overall healing process.
	As a result, a decrease in the pain associated with tissue injury may
  occur.

7

Superior Extended Dosage 

By placing the ActiPatch directly onto the injured tissue the
microchip can deliver an equivalent dosage of a full size pulsed diathermy
device. 

Intermittent Sprayed Therapy Compared to Continual Focused
Cellular Therapy 

The Bioelectromagnetics Research Laboratory, State University of New York has
established that ActiPatch Therapy is providing an equivalent and adequate
dosage of electromagnetic energy for the treatment of soft tissue. ."ActiPatch
Therapy emits a pulsed 1000 Hz signal that is propelled into the body on a 27
MHz frequency wave. These waves introduce an electromagnetic field into the
affected tissue and creates a low frequency electrical current in the damaged
tissue. Each pulse is 100 μsec in duration at a duty cycle of 10% (turned off
for 900 μsec,). The induced electrical current affects the cells which have been
traumatized and physically separated by intercellular fluids, precluding the
individual cells in the tissue from communicating with one another.
Electrotherapy's induced electrical signal serves as a synchronization signal,
allowing cells to reestablish communication and begin working as a tissue again
and terminating the inflammatory response. Exposures in the extremely low
frequency range (less than 3000 Hz) induced electric field levels of less than
10 microvolts/centimeter, corresponding to induced power levels less than 10-12
W/cm3, are sufficient to produce significant biological effects. 

While much smaller energy levels are required to achieve a biological
stimulation, the field intensities utilized by ActiPatch devices are still well
above the threshold levels established by the NIH Working Group. Based on recent
work focusing on establishing thresholds for continuous cell exposure, ActiPatch
devices induce electric fields which are at least 10 times the threshold levels
required to achieve a biological response. 

8

Key points of evaluation: 

	Cumulative absorbed energy at the skin level is equivalent to traditional
  high power devices.
	Effect of continuous delivery provides greater therapeutic benefit.
	The BioElectronics therapy power level is 6 to 9 orders of magnitude
  higher than that which is required to show a biological effect.

Two key questions arise: 

	is the reduced power of the ActiPatch compensated by the close proximity
  to the tissue and the longer treatment durations, and
	is the device delivering an efficacious therapeutic dose of
  electromagnetic energy to the tissues?

The answer to both of these questions is yes. While the ActiPatch field
intensity is 150 times less than the traditional devices, ActiPatch is used
continuously, as compared to the relatively short treatments. An antibiotic
analogy would possibly be that of a time released patch: a timed release
distributes therapy throughout the day instead of in one or two doses. Total
dose to the tissues is similar. In the same manner, therapeutic, efficacious
PEMFs are induced in the tissues by the ActiPatch, resulting in increased
capillary flow, edema reduction, and the other effects discussed. 

The literature on PEMF effects shows that the ActiPatch power level is 6-9
orders of magnitude above the threshold for demonstrated cell and tissue effects
in vitro. Required power density levels to achieve field-induced tissue
effects are shown in the table below. PEMFs have been shown to influence cell
behavior in in vitro models wound healing, of morphological adaptation
(cellular alignment in the induced electric field), and in vitro models
of differentiation. 

The ActiPatch affixes onto patient for a convenient 24-hour treatment, with
an "overnight" suggested minimum treatment time. Therapeutic efficacy requires
consideration of the treatment time difference factor. ActiPatch Therapy Device
produces a 24 hour absorbed energy of 630 mJ/cc compared to traditional pulsed
electromagnetic devices which produce a 15 minute absorbed energy in the range
of 110 mJ/cc at the 1.5 watt power setting This suggests that a 6 to 8
hour ActiPatch Therapy treatment is well within the range of efficacy for soft
tissue injuries. 

ActiPatchTM Therapy power density at the skin surface is between 14 and 73 uW/cm2.
It is reasonable to assume that 10% of the incident energy is absorbed in the
first centimeter of tissue depth, or maximum energy absorption of up to 7.3uW/cm3
in skin. While that absorbed power appears to be a very low exposure level, in
fact, this level is well above the threshold levels necessary to ensure
non-thermal biological responses from electromagnetic field exposures. To
understand this statement it is important to note that non-thermal effects of
electromagnetic field exposure are due to the induced electric field in the
tissue and not the magnetic field. ActiPatch produces an induced electric field
of typically 10 milliVolt/cm. 

In a fibroblast/collagen wound healing model, field intensities as low as 30
uV/cm rms were sufficient to significantly reduce protein excretion by cells
(consistent with a reduction in edema and scarring) for exposure durations of 12
hours (McLeod, et al. 1987). This field intensity corresponds to an induced
power level of 10-11 Watts/cm3. More recently,
investigations on other aspects of cell phenotypic expression related to the
healing process, including differentiation, cell morphologic adaptation, and
cell motility, suggest that even this very low exposure level can be further
reduced by extending the exposure time. In a study on morphologic adaptation of
cells to induced electromagnetic fields, 3.5 uV/cm rms electric fields were
found to be sufficient to induce significant morphologic changes if the exposure
times were extended to 24 hours, corresponding to induced power levels of 10-13
Watts/cm3 (Lee & McLeod, 2000). Moreover, a study on regulation of
differentiation in mesenchymal cells, utilizing exposure durations of up to 64
hours, showed that cells were capable of responding to induced field intensities
as low as 0.7 uV/cm rms, corresponding to induced power densities of 5x10-15
Watts/cm3 (McLeod & Collazo, 2000). 

9

It is clear, therefore, that use of ActiPatchTM Therapy, resulting in adsorbed
power levels in the range of 7.3 uW/cm3, provides field exposure
levels at the target tissue that are five to nine orders of magnitude above the
thresholds which have been established for non-thermal electromagnetically
induced biological effects at the cell and tissue level. 

Second, these studies clearly demonstrate that progressively longer treatment
durations are associated with progressively lower required field levels to
obtain significant biological effects. That is, it is not the power level, per
se, that is relevant, but the product of duration of exposure and power
delivered to the tissue. 

	In vitro wound
    healing (McLeod, 1987)	10-11
    W/cm3
	In vitro
    morphological adaptation (Lee and McLeod, 2000)	10-13
    W/cm3
	In vitro
    differentiation (McLeod and Collazo, 2000)	10-15
    W/cm3

 

 

10

Confirming Low Power and Extended Treatment Duration Clinical Studies 

The following are published clinical studies conducted at 27 MHz at a power
at or below the traditional pulse electromagnetic short field therapy levels.
The studies explored each of the key stages of healing inflammation,
regeneration and remodeling in various medical specialties. Those studies
demonstrated that ActiPatch Therapy accelerated healing, reduced swelling and
bruising, and increase the tensile strength of the wounds. 

The Company is conducting additional clinical studies to expand the formal
indications for ActiPatch Therapy in the United States. The most promising areas
are: sprains and strains, heel pain, chronics wounds, oral surgery, and
abdominal surgery. 

11

Wound Studies 

Direct Comparison of Standard PEMF Device and a Low Power Prototype ActiPatch,
Effect of a 15-Watt Pulsed 27.12 MHz and a 2mW pulsed 3 MHz device on the
tensile strength of rat abdominal wounds,
Bentall, RHC, (1981). p23. In: Proceedings of the 1st annual
meeting of the Bioelectrical Repair and Growth Society, November 9-11,
Philadelphia, USA, 

These results clearly show that pulsed radio frequency energy from a
prototype ActiPatch Therapy device and a DiaPulse device both have a significant
effect on the tensile strength of rat abdominal wounds. Despite the gross
differences in the physical size and power output of the two devices (15 Watt
and 2 milliWatt), they showed a very similar profile of activity in enhancing
the development of tensile strength. This confirms that the effect of pulsed
radio frequency energy on wound healing is not thermal in origin. 

Richard Bentall, MD 

The tensile strength of a post-operative wound is of paramount importance. In
this laboratory study treatment with pulsed radiofrequency energy was found to
have a significant effect upon tensile strength. 

Aim 

The purpose of this study was to compare, at two time
intervals following surgery (2 days and 8 days), the tensile strength of rat
abdominal wounds treated with one of two pulsed radiofrequency devices (1.5 Watt
or 2 milliWatt nominal output) compared with a placebo equivalent (1.5 Watt
light bulb). 

Method 

150 Wistar rats (200 grams) were used in this study. Under
ether anaesthesia a 2.5 cm transverse incision was made in the abdominal wall
through the peritoneal cavity of each rat. The wounds were closed with five
interrupted silk sutures through all layers and the rats were randomly assigned
to one of three treatment groups: 1.5 Watt, 2 milliWatt or placebo. 

The daily treatment regimen for each of the groups respectively was three
episodes of 20 minute exposure to the 1.5 Watt device, overnight exposure to the
2 milliWatt device, or three episodes of 20 minute exposure to the 1.5 Watt
light bulb. Treatment continued until the randomised sacrifice of each animal at
two or eight days post-operatively. 

Prior to sacrifice each rat was anaesthetised, a plastic bag was inserted
into its peritoneal cavity and its sutures were removed. The bag was
progressively inflated with water at a constant rate until the wound ruptured.
The pressure of water in the bag was recorded continuously to determine the
resistance of the wound to increasing intra-abdominal pressure. 

12

Device Specifications 

	
    i. Placebo Device - 15 Watt light bulb
	 
	
    ii. 1.5 Watt Pulsed RF Device:
	 
	
     
	Nominal Power
	
    Output
	1.5 Watts
	
    Carrier Frequency
	27 MHz
	
    Pulse Width
	65 microsecs
	
    Pulse Repetition Frequency
	200Hz
	
     
	 
	
    ill. 2 mWatt Pulsed RF Device:
	 
	
    Nominal Power Output
	: 2 mW
	
    Carrier Frequency
	: 3 MHz
	
    Pulse Width
	: 100 microsecs
	
    Pulse Repetition Frequency
	: KHz

Results 

The profiIes of the tracings of pressure against time were
different at the two different time intervals. Two days after incision the:
wounds were still quite weak and there was a single point at which each wound
completely broke down. Eight days after incision there was a biphasic response.
A first pressure peak was reached when the fascia ruptured, allowing the bag to
spread out and the water pressure to drop. A second peak was then reached when
the: skin itself paned. 

Three separate methods were used to quantify the tensile
strength of the wounds: 

  I. end volume - the total volume of water infused into the bag
  when the wound burst. This value extremely variable at eight days and is not
  reported. 

  
    a. area under the graph - this integrates the time period
    (sees) over which pressure or water 

    b. (mmHg) was withstood and hence allows for different sized
    peritoneal cavities and for differences in the extent to which the bags
    spread out. 

  

  II. wound index (8 day groups only) - this is the sum of the
  two pressure peaks multiplied by the time difference (in sees) between them.
  Tests were used to compare the experimental groups with the placebo groups and
  the results are shown in Table 1. 

TABLE 1: Tensile Strength or Rat Abdominal Wounds at Two and
Eight Days 

Following Transverse Surgical Incision. 

	 	 	2 DAY	 	 	8 DAY	 
	 	value	% Increase	'p' Value	value	% Increase	'p' value
	PLACEBO GROUPS	 	 	 	 	 	 
	n ... 2.S	 	 	 	 	 	 
	End volume	97.7	 	 	 	 	 
	Area under graph	1777.2	-	-	13116.4	 	 
	Wound index	N/A	-	-	10563.4	 	 
	15 WATT' GROUPS	 	 	 	 	 	 
	n=2.S	 	 	 	 	 	 
	End volume	112.7	15.4	0.025	 	 	 
	Area under graph	2252.2	26.7	0.025	20642.5	57.4	0.025
	Wound index	N/A	-	-	17563.4	66.3	0.01
	2milliWATT GROUPS	 	 	 	 	 	 
	n = 5	 	 	 	 	 	 
	End volume	113.6	16.5	0.025	 	 	 
	Area under graph	3256.6	83.2	0.01	13910.0	1.1	NS
	Wound index	N/A	-	-	15287.0	44.7	0.01

13

Conclusions 

a)    
These results clearly show that pulsed radio frequency energy from both these
devices does have a significant effect on the tensile Strength of rat abdominal
wounds. 

b)    
Despite the gross differences in the physical size and power output of the two
devices (15 Watt and 2 milliWatt), they showed a very similar profile of
activity in enhancing the development of tensile strength. This confirms that
the effect of pulsed radio frequency energy on wound healing is not thermal in
origin. 

Montandon D, D'Andiran G & Gabbiani G (1977) The Mechanism of
Wound Contraction and Epithelialization. Clinics in Plastic Surgery, 4,
325-346. 

Nadasdi M (1960) Inhibition of Experimental Arthritis by
Athermic Pulsating Short Waves In Rats. American Journal of Orthopedics, 2,
105-107. ". 

Newcombe JF (1972) Wound Healing. In: Scientific Basis of
Surgery, Ed. Irvine WT, Pub. Churchill Livingstone, Le. London, pp 433-456. 

Nicolle FV and Bentall RHC (1982) Use of Radiofrequency
Pulsed Energy in the Control of Postoperative Reaction in Blepharoplasty. 
Aesthetic Plastic Surgery, 6, 169-171. 

Peacock EE & Van Winkle W (1976) Wound Repair. Pub.
Saunders, Loc. Philadelphia, pp 1.21. 145.203, 215-231. 

Pullar P (1973) The Histopathology of Wounds. In: Modern
Trends in Forensic Medicine, Vol3, Ed. Mant AK, Pub. Butterworths, Loc. London,
ISBN 0-407-29202'{), pp 64-92. 

Rains AJH & Ritchie HD (1977) Bailey and Love's Short
Practice of Surgery. Pub. HK Lewis, Loc. London, ISBN 0-7186-0431-8. 

Remensnyder JP (1972) Topography of Tissue Oxygen Tension
Changes in Acute Burn Edema. Archives of Surgery, lOS, 477-482. 

Ryan DB & Majno G (1977) Acute Inflammation - A
Review. American Journal of Pathology. 86, 185-276 

Sevitt, S. (1949) Local Blood Flow Changes in Experimental
Burns. Journal of Pathology and Bacteriology, 61, 427-441. 

Sevitt S (1958) Early and Delayed Edema and Increase in
Capillary Permeability After Burns of the Skin. Journal of Pathology and
Bacteriology, 7S, 27-37. 

Shields MA & Dudley HAF (1971)' Oedema at the Site of
Small-Bowel Anastomoses. British Journal of Surgery, 58, 598-600. 

Speer DP (1979) The Influence of Suture- Technique on Early
Wound Healing. Journal of Surgical Research, 27, 385-391. 

Walter JB & Israel MS (1972) Wound Healing.' In: General
Pathology, 3rd Edition, Churchill Livingstone. ISBN 0-7000-1453-5, pp 167-189.

Watson J (1979) The Electrical Stimulation of Bone Healing.
Proceedings of the IEEE, 67. 1339-1352 . 

Watson J & Downes EM (1979) Clinical Aspects of the
Stimulation 01 Bone Healing Using Electrical Phenomena. Medicine & Biology,
Engineering & Computing, 17, 161-169. 

14

Human Experimental Wounds, 
Bentall, RHC 1981 

A key parameter of wound healing is the migration
of cells into the wounded area to repair theinjured tissue. In this double-blind
study, treatment with pulsed RF energy was found to affect the rate at which
full-thickness skin wounds healed, and on the histological appearance of
biopsies performed on the healed tissue. 

First Series 

  a) Aim 

  The aim of this double-blind experiment was to
  determine the effect of treatment using pulsed RF energy on the histological
  appearance of human full-thickness skin wounds of the lower limbs. 

  b) Method 

  A full-thickness disc of skin (2cm diameter)
  was removed from each inner calf of a human volunteer. Each wound was
  allocated an identical treatment device, one active and the other placebo. The
  identity of the devices was revealed only when the wounds had completely
  healed. The devices were worn for 16 hours a day until that time. Biopsies of
  both wounds were performed nine months after healing. The tissue was sectioned
  and stained with either Haematoxylin & Eosin or Van Gieson. The sections were
  examined by a histopathologist who was not aware which wound had been actively
  treated. 

  c) Results 

  
    PLACEBO SIDE 

  

  This showed the features of normal secondary
  wound healing: 

  
    i. thin epidermal layer 

    ii. basal epidermal layer pleomorphism 

    iii. lack of pallisading 

    iv. endarteritis 

  

  The placebo treated wound took 54 days to heal.
  

  
    ACTIVE SIDE 

  

  This showed some advantageous features not
  usually associated with secondary wound healing: 

  
    i. almost normal depth of epidermal layer 

    ii. no pleomorphism 

    iii. basal cell pallisading 

    iv. no endarteritis, but developed endothelium 

  

  The actively treated wound took 39 days to
  heal. 

  Second Series 

  a)     Aim 

  
    The purpose of this second series of wounds
    was to establish when the thickened epithelium observed in the first study
    developed, and to obtain histological evidence confirming earlier cell
    migration into the defect. 

  

  b)     Method 

15

  In this double-blind experiment, a series of twenty (3mm
  diameter) full thickness wounds were made on the upper aspect of the thighs of
  a human volunteer. Ten wounds received placebo treatment, the other ten
  received active treatment. The pulsed RF devices were similar to the lower
  power devices used in the rat tensile strength experiment and were worn
  continuously. Biopsies of the wounds were performed during the initial period
  of healing, at 1, 2, 3, 5, 7, and 14 days. The results shown below are a
  summary of all of time groups. 

c)     Device Specifications 

	
    Power Source. . . . . . . . . . . . . . . . .. .
    . . . . . . . . . . . . . . . . . . . . . . . . . . . ..: 3.5 Volt battery

	
    Carrier Frequency. . . . . . . . . . . . . . . .
    .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 MHz Pulse

	
    Width. .. . . . . . .. . . . . . . . . . . . . .
    . . . . . . .. . . .. . . . . . . . . .. ... . . . . . .. 100 rnicrosecs

	
    Pulse Repetition Frequency. . . . . . . . . . . .
    .. . . . . . . . . . . . . . . . . . . .. . . . . . . . . .: 1 KHz

d)     Results 

PLACEBO GROUP 

As with the first series these wounds showed the typical
features of secondary wound healing: 

  i. thin epidermis 

  ii. basal layer pleomorphism 

TREATED GROUP 

These wounds showed: 

  i. earlier epidermal budding, 

  ii. earlier migration into the wound, 

  iii. earlier appearance of rate ridges, and 

  iv. almost normal depth of final epidermis. 

Conclusions (First and Second Series) 

  Treatment of skin wounds with pulsed radio frequency energy
  influenced the processes of acute secondary wound healing. The rate of healing
  was accelerated and the histological appearance of the actively treated wounds
  showed that the healed epidermis was more like normal skin than the scar
  tissue typical of secondary wound healing. The effect demonstrated in these
  studies indicates that low-level pulsed radio frequency energy has therapeutic
  potential. 

A Portable Pulsed EMF (PEMF) Device To Enhance Healing Of
Recalcitrant Venous Ulcers: A Double-Blind, Placebo-Controlled Clinical Trial.
Br J Dermatol Aug; 127(2): 147-154. Ronald O. Perelman Dept of Dermatology, New
York Univ Med Ctr, New York. PELUT system (Geomed, Inc.) 

A prospective, randomized, double-blind, placebo-controlled,
multicentre study assessed the clinical efficacy and safety of pulsed EM limb
ulcer therapy (PELUT) in the healing of recalcitrant, predominantly venous leg
ulcers. The portable device was used at home for 3 h daily during this 8-wk
clinical trial as an adjunct to a wound dressing. Wound surface area, ulcer
depth and pain intensity were assessed at wk 0, 4 and 8. At wk 8, the active
group had a 47.7% decrease in wound surface area vs. a 42.3% increase for
placebo (p<0002). 50% of the ulcers in the active group healed or markedly
improved vs. 0% in the placebo group and 0% of the active group worsened vs. 54%
of the placebo group (p<. 001) significant decreases in wound depth (p<. 04) and
pain intensity (p<. 04) favoring the active group were seen. Patients whose
ulcers improved significantly after 8 wk were permitted to continue double-blind
therapy for an additional 4 wk. 11 active and 1 placebo patient continued
therapy until wk 12, with the active treatment group continuing to show
improvement. There were no reports of adverse events attributable to this
device. The PELUT device was a safe and effective adjunct to non-surgical
therapy for recalcitrant venous leg ulcers.

16

Electromagnetic transducer (attached to signal generator 9 V battery)
containing coils for magnetic focusing strapped over wound dressing with
elasticized Velcro strap; induces low level, nonthermal electrical field of
approx. 0.06 mV/cm; has 3 part pulse of 3.5 ms total width, 25% duty cycle, 22
Gauss; applied (at home) 3 hrs/day on top of dressing for 8 to 12 weeks (or
healing) 

Effect of low frequency pulsing EMFs on skin ulcers of venous origin in
humans: a double-blind study. J Orthop Res Mar; 8(2): 276-282. Dept of Med
Angiology, Arcispedale S. Maria Nuova, Reggio Emilia, Italy. 

The effect of an EMF on the healing of skin ulcers of venous origin in humans
has been investigated in a double-blind study. 44 patients have been admitted to
the study; one-half were exposed to active stimulators (experimental group) and
the remaining to dummy stimulators (control group). The stimulation was
scheduled to last a maximum of 90 d. The success rate was significantly higher
in the experimental group both at d 90 (p<. 02) and in the follow-up period (p<.
005). The effect of the EMF may last even when the stimulation is over. No
ulcers worsened in the experimental group, while 4 worsened in the control
group. 25% of the patients in the experimental group and 50% in the control
group experienced recurrence of the ulcer. Stimulation with an EMF is a useful
adjunctive therapy in the management of these patients. 

The treatment of pressure sores using pulsed electromagnet energy (PEME)
Seaborne D., Quirion-De Giradi C., Rosseau M., Rivest M., Lambert J., (1996),
Physiotherapy (Canada), 48, 131-7 

This study evaluated the effectiveness field strengths insufficient to create
noticeable heat. The mean power densities delivered to the tissues were 5.6 W at
20 pps (power density 0.036 to 0042 W/cm2) and at 30.8 W at 110 pps (power
density of 0.199 to 0.230 W/cm2). PSWD is not an experimental treatment for
pressure at the Hospital Ste-Anne-de-Bellevue, Montreal, Canada. This study
confirmed that PSWD at the low power densities are an effective treatment
modality for pressure sores. 

Stimulators supplied electromagnetic coils with a single pulse of electrical
current generating magnetic field of 2.8 mT @ 75 Hz and 1.3 ms pulse width;
patients instructed to use stimulators at home 3-4 hrs. /day for 90 days or
until healed. 

17

Photographic Evidence of Clinical Effectiveness – 

Superficial Gangrene 

Dr. Bentall effectively treated patients with superficial gangrene and
decubitus ulcers using only the ActiPatch Therapy prototypes for treatment. The
treatments provided dramatic turnarounds in situations where other therapy had
failed to improve the patient's condition. 

Sacral Decubitus Ulcer 

18

Low Pulsed Electromagnetic Therapy (ActiPatchTM) as a Useful and Effective
Adjunct for the Healing of Recalcitrant Wounds, Tracey C. Vlahovic, DPM
Temple University School of Podiatric Medicine 8th and Race Street,
Philadelphia, PA 19107 

Introduction: Lower extremity ulcers, such as diabetic and venous stasis,
are constant challenges for practitioners and patients alike. Physicians are in
a continuous battle with the chronic wound's ever changing environment. Patients
battle with frequent doctor visits and wound dressing changes at home which may
be complicated and confusing. Overall, lower extremity ulcers are challenging
and costly. This said, the goal for chronic wound care therapy is a regimen that
is easy to use for both the practitioner and the patient; aids wound healing,
and is cost effective. This report describes a new product that facilitates this
regimen. 

Electro-therapy has been used for years to aid wound care, decrease swelling,
and reduce pain. Plastic surgeons have recently begun using low pulsed
radiofrequency (RF) electromagnetic field in the form of a small, wearable,
FDA-approved patch to decrease healing time post-blepharoplasty. The small
moldable device increases blood flow to the area without heating surrounding
tissues, thus avoiding tissue damage and it expedites the wound healing process,
which is ideal for any post-operative facial procedure. 

Extrapolation of these impressive results in the plastic surgery field led to
a logical extension of this therapy in the care of chronic wounds of the lower
extremity. Diabetic and venous stasis ulcers both have an underlying impairment
in the natural wound healing process. Increased intercellular edema, which is
almost invariably present both in diabetic neuropathic and stasis ulcers,
impairs oxygen delivery to cells. Without oxygen, cellular metabolic processes
are delayed or even impeded. This aspect is just one of the many roadblocks to
wound healing in diabetic and venous stasis ulcers. 

In the diabetic population alone, increased risk of ulceration is seen in
those with peripheral neuropathy and microvascular damage from constant
repetitive trauma. The recurrence rate of patients with a history of successful
ulcer healing is 66%, with the amputation rate of 12 percent. Unfortunately, the
5-year risk that some level of amputation required on the opposite limb is 50%.
Also, the patient may not seek medical treatment until the wound is
significantly advanced. Sensory loss leads to loss of skin integrity. This can
over time allow a gateway for bacterial invasion. The most common causal pathway
to diabetic ulceration does not happen spontaneously, but can be identified as a
combination of factors: neuropathy, deformity and chronic repetitive trauma. 

Management of diabetic foot ulcers is constantly evolving via various
dressings and growth factor developments. The foundation of comprehensive care
for diabetic foot ulcers is removal of all nonviable tissue, including bone and
soft tissue. Debridement of the ulcer is the first and foremost important step
in healing 2. This is followed by an appropriate dressing that aids
the wound environment to move further in the wound healing phase. 

Combining technology from the plastic surgery field and the ever changing
wound care field, this pilot study utilized a low pulsed electromagnetic field
patch on recalcitrant diabetic and venous stasis ulcers. 

19

Materials and Methods: At the Temple University Foot and Ankle Institute,
four adult African American diabetic males between the ages of 40 to 75 with
ulcers present for longer than three months were admitted into the pilot study.
All patients had at least one palpable pedal pulse and an ulcer of Wagner Grade
II or higher. Three patients had diabetic neuropathic ulcers and one had a
venous stasis ulcer. 

All ulcers had previously been treated with a variety of methods, without
appreciable healing. After informed consent, patients discontinued the prior
methods and utilized the low pulsed electromagnetic field device (ActiPatchTM)
for six to eight hours per day. The size of the wound determined device size:
either 500F or 1000F. The wound was covered with moist saline gauze, ActiPatchTM,
and a dry sterile dressing. When the ActiPatchTM was not in use, the ulcer was
covered with moist saline gauze and dry sterile dressing. Patients kept a
journal of their ActiPatchTM use and brought the log in during their weekly
visits. 

Weekly visits consisted of sharp debridement and surgical scrub followed by
measurement and photographic documentation. Wounds were evaluated for any signs
of infection and new changes such as increased depth or drainage. The ActiPatchTM
device was also evaluated for proper functioning at each visit. Patients were
educated on their daily wound dressing changes. The wounds were evaluated with
the ActiPatchTM once weekly for six weeks total. 

Data: 

Table 1 

	Patient	Age	Location	Week 0	Week 1	Week 2	Week 3	Week 4	Week 5	Week 6
	 	 	 	 	4 x 2.5	 	 	 	 	 	0.7 x
	 	1	66	right leg	cm	4 x 2.3	4 x 2	3 x 1.5	2 x 1.5	1 x 0.7	0.5
	 	 	 	right	0.5 x	 	0.2 x	 	 	 	 
	 	2	60	foot	0.5	0.3 x0.3	0.1	ulcer
    healed	 	 
	 	3	43	left heel	4 x 1	2 x 0.5	1 x 0.3	ulcer
    healed	 	 
	 	 	 	right	2.5 x	 	 	1.7 X	 	 	 
	 	4	74	heel	1.75	2 X 2	2 X 1.5	0.7	1 X 1	1 X 0.5	1 X 0.5

 

20

Pictures: 

Patient 2 at Week 0 and Week 3 respectively 

21

Patient 3 at Week 0 and Week 3 respectively: 

Conclusion/Discussion: The ActiPatchTM has promise in augmentation of wound
healing in recalcitrant ulcers. The ulcers had a steady decrease in side to side
closure and in visible peri-wound edema. The patient with the venous stasis
ulcer also had significant pain relief after two weeks of use. Wounds still
needed to be sharply debrided on a weekly basis, but patients were pleased with
the therapy and its ease of use at home. 

22

ActiPatchTM is a disposable, inexpensive, and highly effective device that
delivers proven therapeutic doses of pulsed electromagnetic field energy to
injured or diseased tissues. The mechanisms involved in its therapeutic
effectiveness include a rapid reduction in edema and inflammation secondary to
improved microvascular perfusion in the areas adjacent to application of the
patch. Edematous tissue impairs the normal communication between cells and is a
repository of noxious agents that accumulate in the soft tissue. The low pulsed
electromagnetic field used in ActiPatchTM decreases this edema which, in turn,
restores normal cell communication. This allows the wound to move through the
wound healing phases more efficiently by creating a better intercellular
environment3. Although this study did not evaluate the biochemical or
histological aspect of this device, the clinical results showed that the device
helped these chronic wounds get through their plateau and begin the healing
process again. 

Future variations in the ActiPatchTM design will allow the patient to wear the
device 24 hours a day thus improving these already impressive results.
Incorporation of the device into an insole or diabetic shoe should provide an
ideal use for ambulatory patients. At this point, the ActiPatchTM design
incorporates a battery that lasts approximately 720 hours. A replaceable battery
pack could prolong the use of the device if the patient has further need. In
addition, a double blind randomized controlled study with a greater patient
number would enhance the results of this pilot study. 

Overall, ActiPatchTM, in my opinion, is an extremely useful adjunct in
improving the healing of recalcitrant chronic foot wounds. In this pilot study,
it facilitated the wound healing process in both diabetic and venous stasis
lower extremity ulcers, and was easy to use from the physician's and patient's
standpoint. 

References:

	Roland D, Ferder M, and Kothuru R et al. Effects of pulsed magnetic energy
  on a microsurgically transferred vessel. Plast Reconstr Surg. 2000;
  105(4): 1371-1374.
	Moss SE, Klein R, Klein BE, Wong TY. Arch Int Med 2003;163:
  2505-2510.

Wachtel H. Firing pattern changes and transmembrane currents produced by
extremely low frequency fields in pacemaker neurons. Hanford Life Sciences
Symposium, 18th, Richland, Wash. Tech. Info. Center. US Dept of
Energy 1979. 

23

Plastic Surgery Clinical Studies 

Blepharoplasty Pilot Study, Bentall, RHC 1982 

A pilot study, conducted by Dr. Bentall with 21 patients,
established clinically meaningful success criteria, such as the effects of
pulsed RF energy on postoperative edema and bruising. The enlarged second study,
with 61 patients, aimed at obtaining numerical estimates of edema and bruising
thus confirming the results of the earlier study as well as quantifying edema
and bruising. During the eighties quantifying edema and bruising was mostly
subjective and the use of more than one assessor to evaluate and measure the
affected area was used. The clinically meaningful 

The surgical procedure of blepharoplasty may be performed under
general or local anaesthesia and involves removal of excess skin and fat from
tl)e upper and/or lower eyelids. The low tension in the skin of the peri-orbital
region means that post-Operative oedema and bruising are inevitable. It is an
ideal clinical model for double-blind evaluation of pulsed RF treatment because
it provides asymptomatic patients who each undergo a bilateral procedure
performed by a single surgeon; the patient acts as his, or her own control. A
double-blind pilot study and a recently completed study are described. 

Pilot Study: (Nicolle and Bentall, 1982) 

a)     Aim 

The purpose of this study was to
determine the effects of pulsed RF energy on the postoperative course of oedema
and bruising following blepharoplasty surgery. 

b)     Method 

The pilot study involved 21 patients who
had surgery performed under local or general anaesthesia. Active and placebo
antennae were manipulated to form a spectacle shape that was held in place on
top of wound dressings. The spectacles were applied immediately postoperatively
and removed after 24 hours. Photographic colour transparencies were taken of the
patient on the first day (when the dressings were removed), and on the third day
(when the sutures were removed), and at six days at the follow-up visit.
Assessment of these slides was made by an independent clinician. 

c)     Device Specifications 

	
    Power Source. . . . . . . . . . . . . . . . . . .
    . . . . . .. . . . . . . . . . . . 3.5 Volt battery

	
    Carrier Frequency. . . . . . . . . . . . . . . .
    . . . . . . . . . . . . . . . . : 27 MHz

	
    Pulse Width. . . . . . . . . . . . . . . . . . .
    . . . . . . . . .. . . . . . .. . .: 100 microsecs

	
    Pulse Repetition Frequency . . . . . . . . . . .
    . . . . . . . . . . . . .1 KHz

Results 

The independent clinician assessed the slides and
determined which of the peri-orbital regions showed clinical evidence of an
improvement - a reduction in oedema, bruising and scleral haemorrhage. Two
patients were excluded due to technical difficulties with the devices. Of the
remaining 19 patients, 11 had visible reduction of the post-operative signs on
the actively treated side, this improvement was still discernable at the sixth
day follow-up visit. In six patients, oedema and bruising was so slight that no
difference was visible. Two patients appeared to have a reduction in the
severity of signs on the placebo treated side. 

24

1984/5 Blepharoplasty Study (Bentall, Bentall and Nicolle, 1985) 

Aim 

In the pilot study no attempt was made
to obtain any numerical estimates of oedema and bruising on which to perform an
analysis. The purpose of the present study is to attempt to replicate the
clinical effect observed in the pilot study and to quantify that effect using a
larger sample of patients. 

Method 

The subjects of this clinical study were
the patients of a plastic surgeon (Mr F V Nicolle) practising in London,
England. All patients attending for bilateral blepharoplasty who gave their
informed consent to participation were entered into the study; there were no
specific exclusion criteria. Patients receiving surgery to the upper lids and/or
the lower lids were included. Patients were randomly assigned a pair of lensless
spectacles to provide treatment to the lids of one eye but not the other. Active
and placebo antennae were fitted into the lightweight spectacle frames and
electrical components were housed in one leg of the frames. The placebo antenna
was electrically shielded to prevent re-radiation from the active antenna which
emitted pulsed RF. energy of the following specifications: 

	
    Nominal Power Output. . . . . . . .. . . . . . .
    . . . . . . . . . . . . : 73 microW

	
    Carrier Frequency. . . . . . . .. . . . . . . . .
    . . . . . . . . . . . . . . : 26 MHz

	
    Pulse Width. . . . . . . . . .. . . . . . . . . .
    . . . . . . . . . . . . . : 73 microsecs

	
    Pulse Repetition Frequency . . . . . . . . . . .
    . . . . . . . . . . .: 900 Hz

Patients therefore acted as their own
control and they were not aware which eye received treatment. Treatment
commenced immecijate1y following surgery and the patients were instructed to
wear the spectacles for 16 hours per day for the following three days. Apart
from this no modifications were made to the normal post-operative care of the
patients. Patients were asked to keep a log, on a small card provided, of the
hours for which they wore the spectacles. 

At each post-operative visit, that is at
one day (a few cases only) and at three, four or five days after surgery, the
nurse took a clinical photograph which was developed into a colour slide. The
clinical logistics of the study precluded the taking of absolutely standard
photographs. Therefore, in order to be able to make a correction to the
measurements for the absolute size of each photograph, it was decided to place a
centimetre scale reference sticker on the forehead of each patient prior to the
clinical photograph being taken. Unfortunately this decision was not taken until
after the first twelve patients had been entered into the study. 

Measurements 

The slides were used to obtain
measurements of bruising and the amount each eye was open and they were also
clinically assessed by a panel of three judges (one surgeon, one nurse and one
lay person). 

The bruising beneath each eye was
recorded by projecting the slide onto a piece of acetate film and then drawing a
planimetric trace of the bruised regions below the median palpebral fissure on
each side. Only the areas of clearly defined red or purple bruising were
included, not the rather diffuse areas of yellow. A System III Image Analysis
Machine (AMS Limited) was then used to measure the area (in square centimetres)
of the planimetric trace beneath each eye. 

The slides were then projected onto a
white piece of paper on which two thin black "+" signs had been drawn. The
height of the palpebral fissure of each eye (at the point of bisection of the
pupil - see Figure 1) and the size of the centimetre scale reference sticker
(when present) were marked off on the "+" to signs with a thin pencil. The paper
was then laid flat to enable the amount each eye was open and the length of the
scale reference sticker to be. measured with a ruler. 

25

To obtain ratings of the extent of oedema, bruising and scleral
haemorrhage the three assessors examined the projected slides and recorded a
rating of each clinical sign on a specially prepared form. The eyes were rated
on the following scale for each sign: 

2.R - The patient's RIGHT eye shows
"significantly less" ____________ than the patient's LEFT eye. 

l. R - The patient's RIGHT eye shows
less ________ than the patient's LEFT eye but this is of "little clinical
significance." 

0 - There is no discernable difference
between the patient's LEFT and RIGHT eyes with respect to __________. 

lL - The patient's LEFT eye shows......etc cf lR above 

2L - The patient's LEFT eye shows......etc cf 2R above 

All of the Day 3 (4 or 5) photographs
were assessed before any of the Day 1 photographs and the three assessors were
blind as to the side of treatment of each patient. 

Analyses 

Bruising and eye-opening data were
ana1ysed using related samples t-Tests and contingency tables were drawn up of
the clinical assessment data and submitted to Chisquare tests of association.

Patients who failed to return the log of
the times the spectacles had been worn or who wore the spectacles for fewer than
eight hours per day for at least two days were excluded from the analysis. 

Because not all of the pictures were
taken with the patients wearing a scale reference sticker it was not possible to
provide a correction factor to the measurement data in every case. Two analyses
were therefore performed. To include all patients, the data was transformed to
the percentage of total bruising or eye opening (see Figure 1) which was on the
active side. The second analysis, which used the measured size of the scale
reference sticker to convert the bruising data to actual areas, is considered to
give a more meaningful picture even though it included fewer patients. 

Results 

PATIENT ENTRY 

There were a total of sixty patients
available for analysis in the present study. Two of these patients failed to
return the log of the times when the spectacles were worn, two had worn the
spectacles for fewer than the required 2 days and fourteen had worn the
spectacles for fewer than the required 8 hours per day. There were thus
forty-two patients entered into the analyses, of whom nine patients had slides
from Day One Post-operation and of these two had slides from Day One only. 

BRUISING 

Figure 2 shows the area of bruising on
the actively treated side as a percentage of the total bruising of both sides.
It can be seen that for the patients as a whole the percentage of the total
bruising which was on the active side was significantly less than 500/0, which
is the outcome which would be expected to occur by chance (t = 2.56, p = 0.015).
This is equivalent to a mean reduction in bruising on the active side of 20.7%
(95 % confidence interval 5.2 % to 33.8%). 

For the 28 patients who had worn the
scale reference sticker it was possible to convert the bruised area measurements
to actual areas. Figure 3 shows these results. It can be seen that the mean area
of bruising on the placebo side was 2.88 sq cms and 'for the active side it was
2.38 sq cms. This difference was again statistically significant (t = 2.47, P =
0.02) and indicates that there was 17.4 % less bruising on the actively treated
than the placebo side (95 % confidence interval 3.7% to 31 %). 

26

EYE OPENING 

Figures 4 and 5 show, for the Day 1 and
Day 3, 4 or 5 photographs respectively, the height of the palpebral fissure of
the actively treated side as a percentage of the combined heights of the
palpebral fissures of both sides. In neither case is this value significantly
different from 50% (Day 1: t -0.52, NS; Day 3, 4 or 5: t =0.62, NS). 

CLINICAL ASSESSMENTS 

Although the clinical sign of oedema is
more striking on the first day following surgery too Few patients with Day 1
photographs were available to permit a meaningful analysis of the clinica1
assessments of them. Even for the Day 3, 4 or 5 photographs there were
not sufficient patients to perform a reliable analysis of the full five
assessment levels. However, by combining the two levels of assessment on each
side (2R and 1R, and, 2L and 1L) and excluding the small number of cases
assessed as showing no difference (see Table I), the cell entries are large
enough to permit meaningful conclusions. It can be seen that there is a strong
association between the clinica1 assessments made and the side of activity of
the spectacles that the patient being assessed was wearing (Pearson Chisquare =
6.4, p = 0.0l). 

TABLE 1. Clinical Assessment of Oedema by Surgeon Assessor 

(Table combining assessment levels). 

  
  	 	
      Less Oedema on Left	
      Less Oedema on Right	
      Total
	
      LEFT SIDE	 	 	 
	ACTIVE	12	5	17
	 	 	 	 
	RIGHT SIDE	 	 	 
	ACTIVE	5	13	18
	 	 	 	 
	
      TOTAL	
      17	
      18	
      35

  

Table 2 similarly shows the same surgeon's assessments of the
patients' bruising. Again the association between assessments made and side of
activity of the spectacles worn is statistically significant (Pearson Chisquare
= 5.9, p = 0.015). Only six patients show any scleral haemorrhage and there is
no evidence of its presence being associated with the side of activity of the
spectacles being worn (Pearson Chisquare = 1.3, NS). 

TABLE 2. Clinical Assessment of Bruising by Surgeon Assessor

(Table combining assessment levels). 

  
  	 	
      Less Bruising on Left	
      Less Bruising on Right	
      Total
	
      LEFT SIDE	 	 	 
	ACTIVE	12	4	16
	 	 	 	 
	RIGHT SIDE	 	 	 
	ACTIVE	6	12	18
	 	 	 	 
	
      TOTAL	
      18	
      16	
      34

  

27

The results of the other two assessors were in broad agreement
with the findings of the surgeon though, with more assessments being recorded as
"no discernable difference," the same levels of significance were not attained.

f) Discussion 

The results of the present study provide objective evidence for
and statistical underpinning of the clinical impressions reported in the pilot
study. After approximately three days of postoperative treatment with low-levels
of pulsed RF energy there is a clear reduction in the area of bruising and in
the observable signs of oedema around the treated eye in comparison with the
untreated eye. 

Oedema occurs during the inflammatory
reaction phase of wound healing, though its influence extends beyond this phase
and may result in lower wound tensile strength (Speer, 1979) and delay in the
onset of the collagen synthesis phase of wound healing (Peacock and Van Winkle,
1976). It is produced by' changes in microvascular permeability, by the
breakdown of extravasated proteins (which increases tissue osmotic pressure), by
increased capillary ground substance (preventing the rise in tissue tension
which opposes further release of exudate) (Walter and Israel, 1972). One
possible mechanism of action of the pulsed RF feilds might be to prevent the
disaggregation of the mucopolysaccharides of ground substance which causes its
increased fluidity and is one of the earliest features of the inflammatory
response. In this way the fluid exudate (oedema) and free red blood cells from
the damaged capillaries (bruising) would be less able to spread from the initial
site of injury. 

It is interesting in this context to note that attempts to model
the effects of electric fields on connective tissue (Grodzinsky, 1983) have
concentrated on the polysaccharides (GAGs) which are the main charge bearing
constituents. 

The height of the palbebral fissure on the active side is expressed as a
percentage of the combined height of the palpebral fissures of both eyes. 

28

29

30

31

32

Analysis of Blepharoplasty Results 

Bruising and Eye opening data were analyzed using related samples – T tests
and clinical assessments data was tabulated and evaluated by chi-square tests of
association to evaluate the statistical significance. As explained in the
publication, the three judges assessed and rated the extent of edema, bruising
and sclera hemorrhage on each patient of both the left eye and the right eye as
follows:

	Right eye is significantly less than left eye
	Right eye is less than left eye
	No difference between right eye and left eye
	Left eye is significantly less than right eye
	Left eye is less than right eye

The assessment of each side left and right were combined. As explained by Dr.
Bentall, data from 42 patients were entered into the analysis and as per table
1, data from 35 patients were actually used, seven patients did not show any
significant difference in the assessment. Most studies using devices similar to
ActiPatchTM Therapy such as TENS, NMS, etc. are conducted on 10-15 patients with
an equal number being controls. Our study conducted with 81 patients, we believe
is adequate and sufficient. 

As explained earlier, each patient had one eye treated with the device and
the other eye had a placebo. Patients therefore acted as their own control. Of
the 42 patients, 21 had the right eye on treatment modality while the left eye
was treated with Placebo. The other 21 had left eye treated while the right eye
was treated with Placebo. 

Figure 4 represents date from day 1. Only data from 9
patients were available since only 28 patients had worn the scale reference
sticker. Of the 28 patients, 9 patients had significant assessment value. This
data was used in the figure. 

As explained in Figure 2, the data for day 3, 4, 5 includes 40 patients. 

Table 1. Contains data on 35 patients that showed significant assessment. The
remaining 7 patients showed significant assessment value. The data from 42
patients who completed the study was used. The ratings were of the extent of the
edema, bruising and sclera hemorrhage. The three assessors examined the slides
with the photographs of each eye and recorded a rating for each clinical sign on
a specially designed form. 

The data from this form was used in the table 1. 

Figure 3, 4 and 5 quantifies bruising and the extent of the edema. 

The data used one of three assessments being (?) that of a surgeon because
the other two assessor's data were in broad agreement with the findings. It was
the opinion of the author and that of the referees that it was not necessary to
duplicate the findings of the two other assessors. 

The study as well as the difficulty in recruiting enough patients, the study
is significant in spite of the relatively small number of patients assessed. 

33

As detailed in the publication, all patients were recruited
through a plastic surgeon (Dr. Nicolle). All patients undergoing bilateral
Blepharoplasty who gave their informed consent were entered into the study. 

There were no specific exclusion criteria other than informed consent. All
patients receiving surgery to the upper lids and/or the lower lids were
included. 

Adverse events were assessed and documented but none were reported. Since all
patients were using identical devices the likelihood of adverse events occurring
were extremely small and unlikely. The major factor would have been infection
and none was reported. 

Published Plastic Surgery Articles 

Nicolle, FV. Bental, RHC. (1982) Use of Radio Frequency Pulsed Energy In the
Control of Postoperative Reaction in Blepharoplasty. Aesth Plast Surg, 6, 169.
See Exhibit C 

Attached are the Pilot Blepharoplasty Study of 21 patients, and a 42 Patient
confirming Blepharoplasty study, the article published in Aesthetic Plastic
Surgery, "Use of Radio-Frequency Pulsed Energy in the Control of Postoperative
Reaction in Blepharoplasty" and Dr. Nicolle's letter. The direct clinical
evidence proves that the ActiPatch device reduces both bruising and edema. Since
Blepharoplasty involves removal of excess skin and fat from the upper or lower
eyelids, where the skin has low tension, postoperative bruising and swelling are
inevitable. Blepharoplasty is therefore a good clinical model for evaluation of
the effects of the ActiPatch device. In the study, for three days following
surgery, bilateral Blepharoplasty patients wore a pair of specially adapted
ActiPatch devices with antennae shaped to form lens-less spectacles with both
and active and placebo side. Neither the patient nor the physician could detect
the active frame. The results show that the areas of bruising and the observable
signs of swelling were statistically lower by more than twenty-percent (20%) on
the side that received active treatment as opposed to the placebo treated eye
lid. 

34

Abstract 

This is a preliminary report of the use of a device to apply small pulses of
radio-frequency energy to surgical wounds in order to improve wound healing. The
device was applied to one eye in 21 patients who underwent bilateral
blepharoplasty. There were no device related complications. In 11 patients,
edema and ecchymosis were noticeably less on the treated side within 24 hours of
surgery. In 6 patients, ecchymosis and swelling were so slight that no
difference between treated and untreated sides was visible. Two patients were
noticeably worse on the treated side. Further studies will be conducted.

Key words: 

Blepharoplasty - Wound healing - Instrumentation 

The first mention in the literature of the use of electricity for healing
purposes was possibly Adams in 1799. He recalls the work of Dr. Adam Birch of
St. Thomas's Hospital, London, in the 1780's using Faradic stimulation to assist
in the relief of pain and inflammation in a variety of skin conditions [I].
D'Arsonval, a French physiologist in the 1880's, first suggested that a
biological system would interact at a molecular and ionic level with
electromagnetic fields of various frequencies and encouraged the use of
shortwave diathermy for physiotherary [2]. In more recent times Ginsberg [7] and
Fenn [5] have demonstrated that a pulsed 27.12 megahertz device can aid in the
resolution of soft tissue swelling and bruising. In the 1970's both Wilson [9]
and Bentall [3] confirmed that these observations ere reproducible in clinical
practice. Other means have also been developed of electrically stimulating me
repair in non-unions, Bassett [2], Fukada [6], and Watson [8] used differing
devices, all of which their final interaction with the tissues induce a current
in the tissues secondary to the electric and magnetic field. These devices are
large and expensive. 

In the past 5 years, a small portable device has been developed by Bentall
which has been used in studies on secondary wound healing and on rat abdominal
wall tensile strength measurements. These controlled studies, using a placebo
device as a control, demonstrated that there was enhancement in the acute wound
healing process of 20-30% in these models. The human wound healing study using
histological criteria pointed also to a more proficient wound healing process
with less pleomorphism in the basal cell layer; almost normal palisading of the
basal cells, which is not normally seen in wounds healing from secondary
intention: and an almost normal height of re-epithelization compared with the
thinned epithelium in the placebo group. These findings encouraged the present
study to be undertaken to ascertain the possible clinical role of such a device.

The study reported here was designed to assess the possible benefit of such
treatment to patients undergoing cosmetic surgery of the face. Blepharoplasty
provided an excellent model, since the lids on each side can be compared for
differences in the amount of ecchymosis and edema. 

Material and Methods 

The device itself consists of a small oscillator tuned to 27.12 megahertz
with a timer switching the oscillator so that small pulses of radio-frequency
energy are emitted from the single turn coaxial coil. The shape of the pulse is
square and is 100 μ sec long, there being 1,000 pulses per second. The power is
from a small nickel-cadmium rechargeable 3.5 volt DC battery which draws 0.5 ma:
the unit may be used for 5 days without recourse to recharging. The area of the
coil is approximately 6 cm in diameter. 

Fig. 1. A patient who underwent upper and lower blepharoplasty on both right
and left eyes. The right eye was treated with Bentall's device and illustrates
the typical response noted in 11 out of 13 cases where sufficient ecchymosis and
edema existed for comparison. In this case, although ecchymosis is similar In
both eyelids, the degree of edema is obviously greater in the untreated left
eye. This difference is most obvious 24 hour, postoperatively, but the relative
improvement is apparent throughout the period of observation. (A) One day
postoperatively, (B), Three days postoperatively, (C) Six days
postoperatively 

35

In order to adapt this device to fit over the eyelid region, 2 wire loops
were designed in the shape of a spectacle frame which can then be held in place
with light padding and a 2 in crepe bandage. Only 1 loop is electrically active,
the other providing a control. This device was applied at completion of
surgery and removed after 24 hours. The device showed no indication as to which
side was active and this was only known to the manufacturer. 

For the purpose of the preliminary report, 21 consecutive cases of
blepharoplasty were treated. Photographs were taken 24 hours postoperatively
when the bandage was removed, after 3 days when the sutures were removed and
after 6 days follow-up. Some cases were of upper and lower blepharoplasty,
others of one set of lids only (fig. D) Some were operated on under local
anesthesia and others under general. No attempt was made to subdivide this group
since a study of all the patients in a consecutive series was considered to be
the most valid basis for comparison. 

Results 

Twenty-one patients were studied and the postoperative course of all of them
was uncomplicated by any contributory factors such as vomiting, coughing bouts,
or trauma which might have influenced the result. Two cases were excluded
because of displacement of the dressings by the patients. No patient complained
of any unusual pain locally or headaches that might have been interpreted as
related to the electrical treatment. 

In 6 cases, ecchymosis and swelling was so slight that no difference was
visible between the treated and untreated sides. In II cases, improvement was
apparent, which was most obvious at 24 hours when treatment was ended. At this
point edema, and to a lesser extent ecchymosis, was distinctly less on the
treated side, and this improvement continued to be apparent after 6 days when
the period of early follow-up ended. Two cases were judged to be worse on the
treated side. 

Discussion 

A patient's most immediate concern following facial cosmetic surgery is
whether they will experience much bruising, swelling, or pain and how long it
will take to recover to a point when it will pass unnoticed during social
contact. This series is small, but the results are so encouraging that reporting
it seems justified. Of course, the study will continue and a much larger number
of cases will be added to this study in the immediate future. We are also now
employing a similar device for incorporation in face and neck lifts, which is
identical electrically but has two larger wire loops to cover the neck and sides
of the face. Devices such as Bentall's have immense possible benefits to plastic
surgery cases, not only in cosmetic cases, not only in cosmetic cases but in so
many situations where the rate of healing and reduction of edema and ecchymosis
are of considerable importance. We look forward to reporting later on a much
expanded series. 

References 

I. Adams G: An Essay on Electricity. Explaining Principals of
That Useful Science and Describing the Instruments. 5th Edition. Dillion and Co,
1799, pp 482-575 

2. Bassett CAL. Pawluk R1. Pills AA: Augmentation of Bone repair by
inductively coupled electromagnetic fields. Science 184:575, 1974 

3. Bentall, RHC.Lekstein, HB. A Trial involving the use of pulsed
electromagnetic therapy on children undergoing orchidopexy. Kinderchirurgic 17
(no 4) November, I975 

4. D'Arsonval A: New method of electrical simulation/ exultation of nerves and
muscles. CR Acad Sci (Paris) 92: 1520, 1881 

5. Fenn JE: Effect of pulsed e!ectromagnetic energy (Diapulse) on experimental
haematomas. Canad Med Assoc J 100:261, 1969 

6. Fukada, ,

7. Ginsberg, AJ: A description of myoathermic short wave apparatus with
clinical applications. NY Acad. Med October 14, 1940 

8. Watson J, Downes EM: The application of pulsed magnetic fields to the
stimulation of bone healing in healing. Jpn J Appl Phys 17:215, 1978 

9. Wilson DH: Treatment of soft tissue injuries by pulsed electrical energy. Br
Med J 2:269. 1972 

36

37

38

39

Pulsed Electromagnetic Field Therapy In Plastic Surgery, 
Brian M. Kinney, MD, FACS, MSME Aesthetic Plastic Surgery, 
January/February 2005 • Volume 25 • Number 1 

40

41

42

in microvascular blood perfusion and more rapid healing of ulcers in diabetic
patients, increased skin perfusion in the forearm of volunteer experimental
human subjects, and improved pedal edema in cardiac patients. In one study,
endothelial cells responded to PEMF with increased growth and angiogenesis, and
it has been suggested that PEMF generally improves wound healing.5 In
another animal model, spinal fusion was improved,6 and in another,
bone-graft take was improved after a state of non-union.7 

In the early 1980s, Bental8 wrote about reduced swelling after
blepharoplasty (on clinical examination) with an older-generation
electromagnetic field device and about effective treatment of soft-tissue
injuries to diminish edema and speed wound healing.9 In 2000, Roland
et al10 reported a statistically significant increase in capillary
sprouting after PEMF treatment, compared with controls, in a double-blind,
laboratory animal model of groin wounds. Further studies in animals that
underwent ligation of the feeding artery to a groin flap showed improved flap
survival compared with controls.11 Markov et al12-14 found
decreased edema and improved wound healing in soft tissues treated with PEMF.
Accelerated wound healing was recently demonstrated in 2 laboratory models in
plastic surgery.15,16 

Potential Electrotherapy Mechanisms 

Electrotherapy has been used for decades to reduce pain and swelling
following surgery. In addition, there is clinical and laboratory evidence of its
efficacy in significantly inducing capillary growth. Now, new technology is
catching up with the clinical evidence and we are reaching a better
understanding of the electrotherapy mechanism of action and learning that very
low power levels, when used over extended periods, can produce results
equivalent to the high power, transient treatments associated with cumbersome
traditional machines. 

Lower power levels with efficient antenna designs facilitate packing the
power of electrotherapy into a miniaturized, wearable, and affordable patch.
Such a patch can help to overcome the hesitation of patients considering plastic
surgery by potentially reducing postoperative pain and recovery time. 

Increasing fluid flow due to its pulsatile action, electrotherapy helps to
reestablish cell membrane potential in vitro, reduces edema, seems to
relieve pain, and appears to ignite healing in vivo, clinically, by
compressing the "inflammatory process." In one device, electrotherapy, when
activated, emits a pulsed radiofrequency signal that is propelled into the body
on a 27 MHz frequency wave. These waves introduce an electromagnetic field into
the affected tissue that induces a low frequency electrical cur-rent in the
damaged cells. Each pulse is 100 μsec in duration and the signal is pulsed at
1000 Hz for a duty cycle of 10% (90% off, 10% on per second). 

The induced electrical current affects the cells, which have been traumatized
and physically separated by intercellular fluids. Each cell stores an electrical
capacitance by actively pumping and maintaining many electrolyte gradients
across the membrane, including a high concentration of potassium and low
concentration of sodium, inside rather than outside of the cell wall. This
pumping mechanism and the relative concentration of the electrolytes have been
diminished through trauma. Electrotherapy's applied low-level induced electrical
cur-rent helps reestablish that electrical capacity. When the cell achieves its
normal resting potential (–70mV), it will emit few chemical pain signals and
inflammatory agents (histamines, nitric oxide, prostaglandin E and others). 

The induced, time-varying electric field created by electrotherapy excites
the lymphatic system and the blood vessels; more quickly pumps the concentration
of fluid from the affected area, and induces capillary growth in healing
tissues. As a result, the physical separation of cells due to increased
extracellular fluid will decrease, and intercellular communications through
tight and gap junctions are potentially improved. Nerves may stop receiving pain
signals and the inflammatory response may be ameliorated while healing is
activated. 

The Future 

The use of PEMF devices preoperatively to induce cap-illary growth and
postoperatively to improve swelling has a scientific underpinning, but efficacy
has not been scientifically proven in clinical studies. Use after facial
surgery, breast surgery, and abdominoplasty may be most beneficial in reducing
edema and, perhaps, pain. Clinical stud-ies indicating decreased use of
postoperative analgesics in plastic surgery have not been published, and
anecdotal reports must be corroborated in light of effects on nerve endings
documented in laboratory studies.17 

As our knowledge of these technologies improves, many more applications may
emerge in treatment of postoperative edema and pain, nerve regeneration,
replantation, rehabilitation, hand surgery, microvascular free-tissue transfer,
and grafting. Clinical studies are currently planned or underway in podiatry for
heel pain, in orthopedics for soft-tissue injuries, in dentistry and oral
surgery after major dental and maxillofacial procedures, and other fields. Wound
healing, inflammation, edema, capillary growth, nerve regeneration, and pain are
almost ubiquitous factors in medicine and numerous applications will be
investigated, both within and outside of plastic surgery. 
。

43

References 

Vallbona C, Hazlewood CF, Jurida G. Response of pain to static magnet-ic
fields in postpolio patients: a double blind pilot study. Arch Phys Med
Rehabil 1997;78:1200-1203. 

Kinney B. Electromagnetic Field Stimulation After CO2 Laser Resurfacing of the
Face. Presented at the American Society of Plastic Surgeons Annual Meeting, Los
Angeles, CA, October 11, 2000. 

Carraway J, Casas L, DiBernardo B, Coleman S, Dobb R, Garica J. Personal
communication. 

National Institute of Environmental Health Sciences, National Institutes of
Health Working Group Report: 1998. Portier C, Wolfe M. 

Assessment of Health Effects from Exposure to Power-Line Frequency Electric
and Magnetic Fields. 1998-3981. 

Yen-Patton GP, Patton WF, Beer DM, Jacobson BS. Endothelial cell response to
pulsed electromagnetic fields: Stimulation of growth rate and angiogenesis in
vitro. J Cell Physiol 1988;134:37. 

Glazer PA, Heilmann MR, Lotz JC, Bradford DS. Use of electromagnetic fields in
spinal fusion: A rabbit model. Spine 1997;22:2351. 

Bassett CAL, Mitchell SN, Schink MM. Treatment of therapeutically resistant
nonunions with bone grafts and pulsing electromagnetic fields. J Bone Joint
Surg Am 1982;64:1214. 

Frederick VN, Bental RHC. Use of radiofrequency pulsed energy in the control of
postoperative reaction in blepharoplasty. Aesth Plast Surg 
1972;6:169-171.

Bental RHC. Low-level pulsed radiofrequency fields and the treatment of
soft-tissue injuries. Bioelectrochemistry and Bioenergetics 
1986;16:531-548. 

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. 

Weber RV, Navarro A, Wu JK, Yu HL, Strauch B. Pulsed magnetic fields applied to
a transferred arterial loop support the rat groin composite flap. Plast
Reconstr Surg 2004;114:1185-1189. 

Markov MS, Pilla A. Electromagnetic field stimulation of soft tissues: Pulsed
radiofrequency treatment of postoperative pain and edema. Wounds 
1995;7:143. 

Markov MS. Electric current and electromagnetic field effects on soft tissue:
Implications for wound healing. Wounds 1995;7:94. 

Itoh M, Montemayor JS, Matsumoto E, Eason A, Lee MHM. Accelerated wound healing
of pressure ulcers by pulsed high peak power electro-magnetic energy (Diapulse).
Decubitus 1991;4:24-25, 29-34. 

Callaghan M, Kinnuncan ER, Ceradini DJ, Simon BJ, Gertner GC. Accelerated Wound
Healing by Pulsed Electromagnetic Fields. 

Presented at the American Society of Plastic Surgeons Annual Meeting,
Phildelphia, PA, October 13, 2004. 

Strauch B. The Clinical Potential of Pulsed Magnetic Fields. Presented at the
American Society of Plastic Surgeons Annual Meeting, Phildelphia, PA, October 8,
2004. 

Sisken BF, Walker J, Orgel M. Prospects on clinical applications of electri-cal
stimulation for nerve regeneration. J Cell Biochem 1993;51:404-409. 

Bibliography 

Cameron MH. Comparison of heat distribution with inductive coil SWD
applicator, capacitive plate SWD applicator, microwave diathermy and ultrasound.
In: Physical Agents in Rehabilitation, from Research to Practice. Chapter
10, Electromagnetic Radiation. St. Louis: Elsevier Science. 1999. p. 325. 

Erdman WJ. Peripheral blood flow measurements during application of pulsed high
frequency currents. Am J Orth 1960;2:196-197. 

Excerpted from Collier's Yearbook 1938, Review of Medicine, in MSN Encarta Encyclopedia 2004. 

Excerpted from Collier's Yearbook 1939, Review of Radio, in MSN Encarta Encyclopedia 2004. 

Mayrovitz H, Larsen PB. Effects of pulsed electromagnetic fields on skin
microvascular blood perfusion. Wounds 1992;4:197-202. 

Mayrovitz H, Larsen PB. A preliminary study to evaluate the effect of pulsed
electromagnetic field treatment on lower extremity periulcer skin
microcirculation of diabetic patients. Wounds 1995;7:90-93. Mericle RP,
et al. Plant Growth Responses. In: Biological Effects of Magnetic Fields. 
New York: Plenum Press; 1964. p. 183-195. 

Sharrard WJW. A double-blind trial of pulsed electromagnetic fields for delayed
union of tibial fractures. J Bone Joint Surg 1990;72B:347-352. 

Note: Dr. Kinney serves on the Board of Directors of the Bioelectronics
Corporation, manufacturer of the ActiPatch device, and formerly consulted for
Electropharmacology, Inc, before its breakup. 

Reprint requests: Brian M. Kinney, MD, 2080 Century Park E., Suite 1110, 

Los Angeles, CA 90067-2009. 

Copyright © 2005 by The American Society for Aesthetic Plastic Surgery, Inc. 

1090-820X/$30.00 doi:10.1016/j.asj.2004.12.001 

Volume 25, Number 1 

44

ActiPatch Therapy Following Cosmetic Surgery of the Face and
Neck: A Valuable Adjunct to the Postoperative Management, Casas, Laurie A.,
MD FACS 

ActiPatch Therapy has become an integral part of the postoperative treatment
plan/regime in my patients following Blepharoplasty, Rhinoplasty, Facelift, Neck
lift and Liposuction of the Neck. After completing a Prospective Observational
Study which evaluated the effects of using ActiPatch on 32 patients (52
procedures) as compared to a control group of 30 patients (45 procedures) who
underwent the same cosmetic procedures without the use of ActiPatch, we found
that ActiPatch Therapy decreased postoperative swelling, bruising , localized
fibrosis and localized discomfort by 30-50%. Because of this Observational Study
I have added ActiPatch Therapy to my postoperative protocol for patients
undergoing cosmetic surgical procedures of the face and neck and who desire a
decrease in their postoperative recovery time. 

I performed a prospective observational study on 32 patients (52 procedures)
using ActiPatch Therapy and compared them to 30 patients (45 procedures) control
group to evaluate the effect of ActiPatch on postoperative 1) swelling and
bruising, 2) localized subcutaneous fibrosis and 3) localized discomfort. Both
groups of patients were on the same preoperative protocol of vitamin supplements
and postoperative protocol which continued the use of supplements and added the
use of Cox 2 inhibitors for localized pain. In addition, all patients had Manual
Lymphatic Drainage with a specific protocol of 2 visits per week for 6 weeks.
Both groups of patients were evaluated by a Nurse Practitioner, the treating
physical therapist and the senior author at 3 days, 5-6 days, 7-10 days, 13-14
days, 21 days, 28 days and 42 days postoperatively. An observational data sheet
was completed at each visit which documented 1) localized pain, 2) swelling and
bruising, 3) the soft tissue fibrosis which is characterized by subcutaneous
lumps and tightness and discomfort when moving the operated part. The ActiPatch
was either placed under the gauze head wrap dressing in the facelift, neck lift
and neck liposuction patients, and at the glabella or corner of the brow in the
Rhinoplasty and Blepharoplasty patients. All patients used the ActiPatch for the
first three days and some continued to use it for a total of ten days. The
endpoint was when all visible bruising had resolved. 

We found that ActiPatch therapy was very effective in decreasing
postoperative swelling and bruising. Specifically, our observers noted a 30-50%
reduction in the number of days the patients had visible swelling and ecchymosis
compared to the control group. Both groups had Manual Lymphatic drainage and
Deep Tissue Release Therapy scheduled for 2 times per week for six weeks.(ref:
"Manual Lyphatic Drainage: An Integral Component of Postoperative Care in the
Plastic Surgery Patient" Presented at the Annual Conference of the American
Society of Lymphology, Chicago, IL August 1999 and "The role of Manual Lymphatic
Drainage in the Postoperative Care of Cosmetic Plastic Surgery Patients",
Presented at the Annual Conference of the American Society of Lymphology, Las
Vegas, Nevada October,2004.) The ActiPatch group required 30-50% fewer sessions
to decrease swelling, bruising and localized discomfort from soft tissue
fibrosis. The endpoint of Lymphatic Drainage Therapy is decided by both the
patient and the therapist who together decide that the operated tissues feel and
look normal. 

ActiPatch Therapy is very useful to decrease the swelling, bruising and
localized discomfort in patients undergoing cosmetic of the face and neck. The
following protocol is now used in my practice for all patients who desire a
decrease in their postoperative recovery time following Cosmetic Surgery of the
face and neck. 

Blepharoplasty: ActiPatch 500 either over each eyebrow, or at
the corner of each brow or under each lower eyelid. 24 hours per day for 3-7
days. It is removed for showering and replaced by moistening the hydrogel. Some
patients used paper tape to help hold the ActiPatch in position. 

Rhinoplasty: ActiPatch 500 at the Glabella 24 hours per day for 3-7 days. 

Facelift: ActiPatch 500 is placed on each preauricular area under the gauze
head wrap dressing. When the dressing is removed the ActiPatch is placed either
in the pre or post auricular area as the swelling drops down the face to the
neck lymph nodes over the first 3-10 days after surgery. 

Neck Lift: ActiPatch 500 is placed on both sides of the neck
under the ear and under the gauze head wrap dressing. When the dressing is
removed the ActiPatch is worn on the neck are where the most swelling and
bruising is visible for the first 3-10 days. 

Neck Liposuction: same protocol as Neck Lift. 

ActiPatch is removed for showering and replaced by moistening the hyrogel.
Some patients use paper tape to help hold the ActiPatch in position. 

45

The Effects of Actipatch Therapy Following Cosmetic Face and
Neck Procedures: An Observational Study, Casas, Laurie A., MD FACS 

46

47

48

Abdominoplasty Post-Operative Pain Control With
ActiPatch, Goh, Kimberley, MD

Grand Strand Plastic and Reconstructive Surgery Center, P.A.

Myrtle Beach, SC 29577 

An abdominoplasty is one of the most painful cosmetic body
contouring procedures we perform. Fear of post-operative pain has always been an
obstacle for patients when considering an abdominoplasty. There is now a new,
portable, lightweight and low cost way to decrease postoperative pain. The
ActiPatch is a device which produces pulsed electromagnetic therapy that helps
reduce swelling, relieve pain and enhance healing.* 

I have been using the ActiPatch 500 for postoperative abdominoplasties for
about six months and have been very impressed at its pain control. Prior to
ActiPatch I had been using oxycodone and diazepam for postoperative pain control
with intra-operative marcaine placed under the flap prior to emergence from
anesthesia. The patients complained of significant pain and usually needed
additional prescriptions for both pain and muscle relaxers within four days of
surgery and often again at one week. Since using ActiPatch postoperatively I
have not written a supplemental prescription for pain control and they have some
left over. Their narcotic and medication needs have now decreased approximately
seventy five percent. 

Initially four patients were placed on ActiPatch for pain
control after abdominoplasties. All patients had standard abdominoplasties with
muscle and skin tightening; one had an augment performed as well. The charts
were reviewed and interviews performed retrospectively to the physician to
evaluate postoperative pain and narcotic use. 

The first patient, A., was a 44 year old woman who had three
full term pregnancies and several months of nursing. She complained of loss of
breast fullness and a saggy abdomen. Physical exam revealed ptosis and
pseudoptosis of her breasts and a lax abdominal wall, especially the upper
abdomen, and loose skin on the upper and lower abdomen. She underwent a standard
abdominoplasty and a bilateral subglandular breast augment. The breast augment
was performed using a smooth round saline Mentor implant 350cc filled to 400cc
in subglandular position through an inframammary incision. The abdominoplasty
resected about 40 X 13 centimeters of skin, and the diastasis recti was
corrected (about an eight centimeter plication). Fourteen cc of 1⁄4% marcaine was
placed under the flap at closure. As the patient was emerging from anesthesia
the ActiPatch 500 was placed on the epigastrum and attached using its adhesive
pad directly on the skin. 

In recovery she needed one oxycodone for immediate
postoperative pain. The evening of surgery she rested comfortably, and on her
first visit on postoperative day one she came for her appointment wearing makeup
with her hair styled and had minimal complaints of pain. She had been taking
only one oxycodone every six hours because she was afraid that it would hurt,
but had no complaints of abdominal pain. She had her oxycodone changed to
mepergan because of nausea, but used very little her first week. She said she
felt "she could have run a marathon" and could not believe how little pain she
had. 

Patient B was a 30 year old woman with two full term
pregnancies who complained of a lax abdomen after multiple pregnancies and a
previous cesarean section five years prior. She underwent a standard
abdominoplasty. Of note is that she had undergone a scheduled knee surgery two
days prior to her abdominoplasty in order to make her recovery simultaneous. At
surgery she had a 14 X 46 centimeter skin resection and an eight centimeter
tightening of her 

49

diastasis recti. Fifteen cc of 1⁄4% marcaine was placed under
the flap at closure. The ActiPatch 500 was activated and placed directly on the
epigastrum after the wound was closed. In recovery she had one oxycodone given
orally. The first evening postop she used less than one oxycodone and one
diazepam every six hours. The first day postop she complained only of knee pain,
and felt that the abdominoplasty was less painful than her previous cesarean
section. She also came in wearing facial cosmetics and had her hair styled on
her first day after surgery. Her first week post op she also used less than 20
each of diazepam and oxycodone. 

Patient C was a33 year old nulliparous woman with a previous submuscular
augment mastopexy who complained of inability to tighten her lower abdomen with
diet and exercise. She underwent a standard abdominoplasty with resection of
approximately 13 centimeter by 43 centimeter skin ellipse, and an eight
centimeter diastasis recti plication. Postoperatively she had an ActiPatch 500
activated and applied to her epigastrum. In the recovery room she had one
oxycodone orally for pain. The evening of surgery she took one and one 5 mg
diazepam. By the evening of surgery her only pain was on moving to stand or
recline. At rest she was pain free and reported less pain than her previous
augment mastopexy. The following week she took one or two oxycodone a day. 

Patient D was a 56 year old with one full term pregnancy who
was interested in improving her saggy lower abdomen. She had a previous lower
midline incision for a cesarean section and a right lower quadrant incision for
a bone graft donor site. She had significant diastasis recti and a small
abdominal pannus. She underwent a standard abdominoplasty with repair of
diastasis and right lower quadrant plication for asymmetrical laxity. She had a
15 X 42.5 skin resection and a six centimeter plication. She had 12 cc of 1⁄4%
marcaine placed prior to emergence under the flap. Postoperatively she had one
ActiPatch 500 device placed on the epigastrum. In the recovery room she had one
oxycodone, and the first evening of surgery, one diazepam and one oxycodone. The
next few days she was taking one to two diazepam once a day and one oxycodone
four times a day. By the end of her first week she had taken about twenty of the
oxycodone and even less of the diazepam. 

The amount of pain relief with the ActiPatch after a major
surgery is impressive. This retrospective review of patients' charts and
interviews demonstrates a marked decrease in postoperative pain and use of
narcotics in abdominoplasty. While the ActiPatch can assist with healing and
reduce swelling, those benefits are difficult to appreciate in actual clinical
practice. The amount of pain relief however is easier to evaluate. There is a
marked decrease in the use of pain medications and as well as a significant
increase in comfort level. It is currently a low cost, small, portable, narcotic
free pain control device, and should be considered in all major abdominal
surgeries. 

50

ActiPatch Pain Control Device, Kimberley B.C. Goh, M.D.

Postoperative pain in an abdominoplasty is usually severe,
and requires significant amounts of narcotics and muscle relaxers to control.
The ActiPatch is a new device that suppresses pain without narcotics. It is a
small, disposable, affordable and easily applied external device that is a
radiofrequency generator. It has been promoted for decreasing swelling,
accelerating wound healing (radiofrequency used in orthopedics to accelerate
boney union) and for pain control. Byron Medical is the distributor for plastic
surgeons. 

I have found that using the ActiPatch for pain control has
made a tremendous difference in my patients' recovery after an abdominoplasty. I
now use it on all of my abdominoplasties. I started applying it to my
abdominoplasty patients in 2003 and some of other patients who were concerned
about postoperative pain control, and desired to be off medication sooner to be
able to return to work. I have not been comfortable using the pain pumps,
especially in those patients who have an implant because of the theoretical
potential for introducing bacteria. This is a simpler, cleaner and less
expensive way to approach surgical pain. 

The response is impressive. I did a retrospective review of
my abdominoplasty patients and looked at the number and amount of the pain
medication prescriptions. I wrote for about one fourth of the usual amount if I
used the ActiPatch. Prior to the ActiPatch they were using about two oxycodone
and ten milligrams of valium every four hours the first few days. After I began
using the ActiPatch, they were using about one fourth of the drugs in the first
week. Also three of these abdominoplasty patients came to my office on the first
day postoperatively with makeup on and their hair done. (The other did not wear
makeup preop.) That was a first! I was using the ActiPatch 500 applied to the
epigastrum in the operating room immediately after the procedure. I have also
used it on my breast augment patients and reduction patients that seem to have a
lower pain threshold, with good results. 

I have had some of my abdominoplasty patients decide that
their back bothered them more than their abdomen after a week or so and moved
the ActiPatch from their abdomen to their back, and found relief. One got so
much relief from her chronic back pain that she came back and bought three for a
long trip to New Zealand! She has asked me if I mind her buying it for her back
during the year. 

ActiPatch for pain control is worthwhile in the postoperative
patient, it allows less narcotic use. The cosmetic patient has a great
appreciation for the earlier discontinuation of narcotics, and it should be
considered for those procedures associated with significant postoperative pain.

51

Podiatric Clinical Studies 

52

Achilles Tendon Pain Management with ActiPatch, James C.
Ricketti, D.P.M. 

Achilles tendon insertion pain is becoming more popular in
the podiatric sports literature. Those problems are arising because of poor
stretching techniques or lack of stretching prior to athletic activities. Shoe
gear has also contributed to the problem with patients wearing shoes that are to
soft or to flexible in the midsole causing midfoot breakdown. 

Achilles tendon insertional problems include tendonitis,
tendonosis and retrocalcaneal bursitis. Historically, those problems have been
treated with stretching programs, physical therapy, heel lifts, orthotics, shoe
changes, heel cups and padding. Casting and even surgery have been performed. A
new treatment has become available to treat those conditions which is portable,
light weight and cost effective. The device will reduce pain and edema. The new
device is called ActiPatch, which produces pulsed electromagnetic therapy that
reduces swelling, relieves pain and enhances healing. 

I started using ActiPatch 250 for those insertional Achilles
tendon problems for approximately one year and have been impressed with the
results. It reduces pain and edema without medication. I started using ActiPatch
on patients who had no insurance to get physical therapy, or who had failed
therapy and other conservative care. 

I chose seven patients with insertional Achilles tendon pain
and treated them with the ActiPatch to the lateral insertion of the Achilles
tendon, day and night for 12 days. All seven patients had pain relief within 24
hours and were able to walk with comfort. One patient had a diagnosed partial
Achilles tendon tear and I had him wear the ActiPatch for four weeks with
complete resolution of the tear and the pain cycle. 

The amount of pain relief and edema reduction was remarkable
with the ActiPatch. The ActiPatch unit is safe and low cost, small, portable and
a narcotic pain-free device. It should be considered as a reliable treatment
modality in the treatment of Achilles tendon insertional problems. 

53

Plantar Fasciitis Pain Management with ActiPatch, James C.
Ricketti, D.P.M. 

2273 Route 33, Suite 204,
Hamilton Square, NJ 08890 - 609-567-1674 

Plantar fasciitis is a painful inflammation of the fibrous band of tissue
which runs from the inferior calcaneus and extends to the digits. Historically,
treatment has consisted of injection, night splints, physical therapy, orthotics,
heal cups, pads, castings and when all fails, surgical excision. 

There is now a new portable, light weight and low cost way to decrease the
pain and edema associated with plantar fasciitis. The ActiPatch is a device
which produces pulse electromagnetic therapy that reduces swelling and relieves
pain which enhances the healing of the plantar fascia. I have been using the
ActiPatch 250 for plantar fasciitis for the past year and I have been impressed
by its pain control. I started using ActiPatch on patients who failed a
conservative treatment regimen and were slated for surgery. The results were
very impressive. 

I chose eight patients with chronic intractable plantar fascia pain and had
them apply the ActiPatch to the medial heel at daytime and the inferior heel at
nighttime. Seven out of eight patients received pain relief within forty-eight
hours. They were able to walk without discomfort. The eighth patient received
some benefits but still had morning pain upon arising while the other patients
did not. 

After twelve-day regimen with the ActiPatch seven patients became pain-free
in the daytime and were then treated with the ActiPatch for another twelve days
at night to reduce their pain cycle totally. None of the seven patients went on
for further treatment or surgery. The only adjunct treatment for these patients
was to continue with their previously fabricated custom foot orthotic devices.

The amount of pain relief obtained from the ActiPatch while treating plantar
fasciitis was remarkable. The benefits of the ActiPatch were pain reduction with
edema reduction. The unit is safe, low cost, small, portable, and a narcotic
pain free device. It should be considered in all plantar fasciitis cases. 

54

Acute Gout Pain Management with ActiPatch Therapy, John
Franceschini, D. P. M. 

Gout is a clinical condition caused by elevation of serum uric acid levels
and the subsequent inflammatory response due to the deposition of monosodium
urate crystals in the joints and soft tissue. Gout has a predisposition for the
joints of the lower extremities especially the first metatarsalphalangeal
joints, but can also affect the ankle joints and the heels. Protein-rich diets,
alcohol use, obesity, renal insufficiency, dehydration or the use of diuretics,
niacin or low-dose aspirin are some common initiating factors. Of course,
medical treatment including dietary manipulation and drug therapy is indicated
for the underlying disease process. 

Initial gout attacks are usually monoarthritic, affecting the joints of the
lower extremities more than 75% of the time. The first metatarsalphalangeal
joint is the site in which over 50% of these acute attacks occur. Initial
symptoms include excruciating pain in the joint with severe joint swelling,
erythema and inflammation. Acute attacks usually peak in 1-2 days, and if left
untreated, may last up to 7-10 days. Typical treatments for the acute attack
include non-steroidal anti-inflammatory agents, including Cox-2 inhibitors, oral
and injectable corticosteroids and oral colchicines. With the recent problems
associated with the use of NSAIDs, especially Cox-2 inhibitors, and the diarrhea
associated with the use of oral colchicines, there is a need for a safer and
more effective treatment for acute gout. 

A new treatment device has become available for this condition which is, in
fact, safe, portable, lightweight and cost effective. The device, ActiPatch,
releases a continuous pulsed electromagnetic field therapy that has been well
recognized to reduce swelling, relieve pain and enhances the overall healing
process. 

The author began using ActiPatch therapy on patients with gout in whom
typical oral treatments were not advisable due to past side effects, such as
diarrhea or other health conditions which prevent the use of oral NSAIDs such as
GI or renal disease. ActiPatch has been most effective in reducing the
inflammation and pain quickly, without the use of medication when
contraindicated. The device is easy to dispense, easy to use and should be used
in conjunction with standard oral medications in those patients who can tolerate
them without excessive side effects. 

Several such examples of the effectiveness of ActiPatch therapy in acute gout
are described herein: 

An 84 year old woman presented to me with acute monarticular gout of the
first metatarsalphalangeal. She had awakened with a red, hot, swollen and very
painful joint. She had a history of gout and she knew that she could not
tolerate colchicines and GI problems made NSAIDs a poor choice for her. I
dispensed an ActiPatch 500 with instructions to place it over the affected
joint, as long as possible, during the day and all night. Her serum uric acid
level was 10.6 mg/dl; well outside the 2-7.5 mg/dl normal range. She obtained
80% relief of her pain in 24 hours and full relief in 48 hours. 

Another example was a 93 year old woman with a 24 hour history of
inflammation and severe pain in the plantar portion of her right heel, that
occurred with walking and off weight bearing. She had a history of gout and her
serum uric acid level was 11 mg/dl. She could not tolerate colchicines and could
not take NSAIDs or Tylenol due to renal insufficiency. She was given an
ActiPatch 500 with instructions to place it over her heel as much as possible
during the day and at night. She obtained 80% relief of her pain in 48 hours and
full relief within one week. 

The level of pain relief my patients have experienced was remarkable with
ActiPatch therapy. ActiPatch is a safe, portable, low-cost and a well tolerated
device which reduces pain and swelling. It should be considered as a reliable
treatment modality, alone or in combination with well tolerated medications, for
the treatment of acute gout. 

55

Orthopedics 

Professional Sports Teams Using ActiPatch 

A list of professional sports teams that have bought and are using ActiPatch:

  Football 

    NY Giants 

    NY Jets 

    Baltimore Ravens - Tony Villani, Head Trainer is a Member of
  Athletic Trainers Advisory Committee 

    Green Bay Packers 

    Detroit Lions 

    San Francisco 49ers 

    San Diego Chargers 

  
  Baseball 

    Chicago White Sox - Herm Schneider, Head Trainer is Chair
  of Athletic Trainers Advisory Committee 

    NY Mets 

    NY Yankees 

    Milwaukee Brewers 

    Pittsburgh Pirates 

  
  Basketball 

    NY Knicks 

  
  Soccer 

    NY MetroStars 

Pulsed High Frequency (27 MHz) Electromagnetic Therapy For Persistent Neck
Pain, A Double Blind, Placebo-Controlled Study Of 20 Patients, Foley-Nolan,
Barry, C., Coughlin, RJ, Roedn, R. , Orthopedics April 1990 Vol 13/No 4, 445-451

A double-blind controlled study to examine the effect of PSWD on persistent
neck pain. Subjects had persistent pain of eight weeks or more duration; pulsed
SWD was applied via a cervical collar for a minimum of eight hours per day. The
mean power supplied was 1.5 mW/cm2, the pulse width 60 microseconds and the
frequency 450 cycles per second. Pain and range of movement were assessed after
three and six weeks' treatment. Those receiving active treatment demonstrated an
increase in range and a decrease in pain, which continued over the full period.
A placebo group did not demonstrate the same improvement. This study
demonstrates the effectiveness of a very low powered device for extended
treatment duration. 

Low Energy High Frequency Pulsed Electromagnetic Therapy For
Acute Whiplash Injuries. A Double Blind Randomized Controlled Study,
Foley-Nolan, Moore, K. Codd, M., Barry, C., O'Connor, P., Coughlin, RJ. ,
Scandinavian Journal of Rehabilitation Medicine (1992); 24 (1): 51-59. 

This study confirms the previous study, which establishes that low energy
high frequency pulsed electromagnetic therapy administered for 8 hours a day is
effective in acute and persistent neck pain. 

56

Treatment of Supraspinatus Tendonitis and Lateral
Epicondylitis with ActiPatch Therapy, Dr. Michael Brady, D.C 

Dr. Brady explains: "Supraspinatus Tendonitis is a powerful inflammation of
the tendon sheath, which inserts into the superior facet on the greater tubercle
of the humerus. Lateral Epicondylitis (Tennis Elbow) is characterized by pain
and inflammation at or just distal to the lateral, epicondyle of the humerus.
Both conditions are musculoskeletal in nature and tend to occur due to
repetitive forceful movements. Historically, treatments have consisted of
injection, physical therapy, ultrasound, cryotherapy, and when all else fails,
surgical intervention. 

"A new lightweight, portable device (ActiPatch(TM) -- BioElectronics Corp.)
has shown to decrease the pain and inflammation associated with both conditions.
The ActiPatch(TM) 500 is a pulse electromagnetic therapy that reduces swelling
and pain while enhancing the time factor involved with the healing process of
both Supraspinatus Tendonitis and Lateral Epicondylitis. 

"I chose six patients in total to apply the patch, four with Supraspinatus
Tendonitis and two with Lateral Epicondylitis. The patients with Supraspinatus
Tendonitis applied the patch to the posterior portion of the deltoid, parallel
with the Supraspinatus Tendon of the greater tubercle of the humerus. The two
patients with the Lateral Epicondylitis applied the ActiPatch(TM) 500 to the
brachio-radialis muscle over the lateral epicondyle. The six patients wore the
ActiPatch(TM) continuously during work and sleeping hours. During the other
times of the day the patients were instructed on adjunctive treatment with a
six-day protocol, in which the ActiPatch(TM) was not worn. The adjunctive
treatment consisted of icing the area for the first 48 hours and nothing but
moist heat the last 48 hours. 

"At the end of the six-day protocol, all six patients showed significant
decrease in swelling and pain response. The four patients with Supraspinatus
Tendonitis also showed some additional benefit with range of motion. All six
patients revealed positive results. I feel that the electromagnetic current the
patients were receiving during sleep and work allowed for a more enhanced
healing time, and a better outcome for both tendon conditions. Since the unit is
so lightweight, inexpensive, portable and non-narcotic, I would suggest further
research into both these conditions. I also feel that further investigation of
tendon injuries such as Pre-Patellar Tendonitis and Stenosing-Tenosynovitis
should be researched and studied with the use of the ActiPatch(TM) as a stand
alone therapy." 

Dermatology 

Therapeutic Effect Of A Very Low Powered Herzian Wave Transmissions,
Debelle M., Loerhtier J., Berghmans M., et al. (1977) Brux_Med, 57, 12,
551-63 

The therapeutic effects of treatment with a low power (0.5 Watts peak power)
27.12 MHz electromagnetic devices with a flexible antenna of approximately 13x13
cm, which is placed in contact with tissue surface, are reported. Treatments of
1.5 hours/day, twice a day for 6 weeks to three months were utilized in treating
a variety of skin conditions including eczema, venous ulcers, arterial ulcers,
and acceleration of healing from skin replant surgery following trauma.
Reduction in pain and edema was evident, in most cases, within one day, a
significantly shorter time period as compared to control cases. In a multicenter
study involving over 30 cases of skin replants following trauma, healing was
observed to be twice as fast as control cases. The authors attribute the
efficacy of the therapy primarily to the analgesic and anti-inflammatory effect
of the electromagnetic treatment. 

57

Conclusion

The above peer-reviewed studies, from clinicians around the
world, adequately address and substantiate the clinical evidence of the
effectiveness the ActiPatchTM therapy. 

Clinical References: Low Power 27 MHz Clinical Studies 

Foley-Nolan, Moore, K. Codd, M., Barry, C., O'Connor, P., Coughian, RJ. Low
Energy High Frequency Pulsed Electromagnetic Therapy For Acute Whiplash
Injuries. A Double Blind Randomized Controlled Study. Scandinavian Journal of
Rehabilitation Medicine (1992); 24 (1): 51-59. 

Sarma, GR., Subrahmanyam, S., Deenabandhu, A., Babu, CR., Madhivathanan, S.,
Kesavaraj, N., Pulsing Magnetic Fields On Plantar Ulcers. Madras Institute of
Magnetobiology, India, Indian J Lepr. 1997 Jul-Sept 69(3) 57-68 PMID: 9394172
UI: 98056011. 

Bentall, RHC, (1981a). Effect of a 15 Watt Pulsed 27.12 MHz and a 2mW pulsed
3 MHz device on the tensile strength of rat abdominal wounds, p23. In:
Proceedings of the 1st annual meeting of the Bioelectrical Repair and
Growth Society, November 9-11, Philadelphia, USA. 

Bentall, RHC (1982) Present Clinical Uses of Radio Frequency Induced Currents
and Their Possible Role in The Future. Br J Cancer, 45, Suppl V, 82. 

Nicolle, FV. Bental, RHC., (1982) Use of Radio Frequency Pulsed Energy In the
Control of Postoperative Reaction in Blepharoplasty. Aesth Plast Surg, 6, 169.

Ieran M, Bagnacani M, Zaffuto S, Moratti A, Cadosi R, (1990) Effects Of Low
Frequency Pulsing Electromagnetic Fields On The Healing Of Skin Lesions Of
Venous Origin 

Seaborne D., Quirion-De Giradi C., Rosseau M., Rivest M., Lambert J., (1996)
The Treatment Of Pressure Sores Using Pulsed Electromagnet Energy (PEME)
Physiotherapy (Canada), 48, 131-7 

Stiller MJ, Grace H, Pak, j, Shupack, l, Thaler S, Clare
Kenny and Lorrie Jondreau (1993) British Journal of Dermatology 127,147-154 A
Portable Pulsed Electromagnetic Field (PEMF) Device To Enhance Healing Of
Recalcitrant Venous Ulcers: A Double-Blind, Placebo- 

Clinical References: Other Pulsed Electromagnetic Therapy Studies 

ARONOFSKY DH: Reduction of dental postsurgical symptoms using
non-thermal pulsed high-peak power electromagnetic energy. Oral Surgery, Oral
Medicine, Oral Pathology, 32(5):688-696, Nov 1971 

BARCLAY V, COLLIER RJ, JONES A: Treatment of various hand injuries by pulsed
electromagnetic energy (Diapulse). Physiotherapy, 69(6):186-188, Jun 1983 

58

BENTALL RHC, ECKSTEIN HB: (a) Klinische aspekte einer therapeutischen
untersuchung beiorchidopexierten kindern. Aktuelle Urologie, 6(4) (Stuttgart)
(in German), Oct 1974 (b) A trial involving the use of pulsed electromagnetic
therapy on children undergoing orchidopexy. Zeitschrift Fur Kinderchirurgie,
17(4):380 

BOWDEN REM, RAJI ARM: Effects of high peak pulsed electro-magnetic field on
the degeneration and regeneration of the common peroneal nerve in rats, The
Journal of Bone and Joint Surgery; 65B (4):478-492, 1983 

CAMERON BM: Experimental acceleration of wound healing. American Journal of
Orthopedics, 3(11):336-343 Nov 1961 

CAMERON BM: A three-phase evaluation of pulsed high frequency, radio short
waves (Diapulse), 646 patients. American Journal of Orthopedics, 6(3):72-78,
March 1964. Methodist and St. Lukes Hospital, Houston, Texas. 

COMOROSAN, S., The Effects of Diapulse Therapy on The Healing of Decubitus
Ulcers, Rom. J Physiol, 1993, 30, 1-2p. 41-45 

DUMA-DRZEWINSKA A, BUCZYNSKI ZA, WEISS M: Pulsed high frequency currents (Diapulse)
applied in treatment of bedsores. Polski Tygodnik Lekarski, XXXIII(22):885-887,
in Polish 

ERDMAN WJ: Peripheral blood flow measurements during application of pulsed
high frequency currents. American Journal of Orthopedics, 2:196-197, Aug 1960.
University of Pennsylvania, School of Medicine, Philadelphia. 

FENN J: Effect of pulsed electromagnetic energy (Diapulse) of experimental
hematomas. The Canadian Medical Association Journal, 160:251-254 Feb 1969 

GOLDIN J: The effects of Diapulse on the healing of wounds: A double-blind
randomized controlled trial in man. British Journal of Plastic Surgery,
34:267-270, 1981 

IONESCU A: Study of efficiency of Diapulse therapy on the dynamics of enzymes
in burned wound. The Bulletin and Clinical Review of Burn Injuries, I(II):25-26,
Apr 1984 

IONESCU D, IONESCU A: Results of microsurgical suture in 200 nerves.
Chirurgiae Plasticae, 26(3):166-183. 

ITOH M, MONTEMAYOR JS, MATSUMOTO E, EASON A, LEE MHM: Accelerated wound
healing of pressure ulcers by pulsed high peak power electromagnetic energy (Diapulse).
Decubitus, 4(1):24-25, 29-34, 1991 

JAYAKUMAR K, RAJAGOPLAN T, SAMBASIVAN, BAI S. Effect of pulsed
electromagnetic field (PEMF) in cerebral oedema. Neurology India 1986;
34:241-247 

KIWERSKI J, CHROSTOWSKA T, WEISS M: Clinical trials of the application of
pulsating electromagnetic energy in the treatment of spinal cord lesions. Narz.
Ortop, Pol., 45(3):273-277, 1980 

59

Kloth LC, Berman JE, Sutton CH, Jeutter DC, Pilla AA, Epner ME, Effect of
pulsed radio frequency stimulation on wound healing: a double-blind pilot
clinical study. Bersani F, ed. Electricity and Magnetism in Biology and
Medicine, New York Plenum; p 875-878 

RAJI ARM. Effects of high peak pulsed electromagnetic field on degeneration
of the common peroneal nerve in rats. Lancet 1982;444-445 

RHODES LC: The adjunctive utilization of Diapulse therapy (pulsed high peak
power electromagnetic energy) in accelerating tissue healing in oral surgery.
The Quarterly of the National Dental Association, 39(4):166-175, Jul 1981 and
40(1):4-11, Oct 1981 

SALZBERG CA, Cooper-Vastola SA, et al (1995). The Effects of Non-Thermal
Pulsed Electromagnetic Energy (Diapulse) on Wound Healing of Pressure Ulcers in
Spinal Cord-Injured Patients: A Randomized Double-Blind Study. Wounds 7(1):
11-16 

SHERMAN, RICHARD A., Treatment of Migraine With Pulsing Electromagnetic
Fields: A Double-Blind, Placebo-Controlled Study, (Headache 1999; 39:567-575)

SILVER H: Reduction of capsular contracture with two-stage augmentation
mammaplasty and pulsed electromagnetic energy (Diapulse therapy). Plastic and
Reconstructive Surgery, 69(5):802-805, May 

TUNG S, (July, 1995). The Application of Diapulse in the Treatment of
Decubitus Ulcers: Case Reports. Contemporary Surgery. 47(1): 27-32. 

WILSON DH, JAGADEESH P, NEWMAN PO, HARRIMAN DGF: The effects of pulsed
electromagnetic energy on peripheral nerve regeneration. Annals of the New York
Academy of Sciences, 238:575-580, Oct 1973. (Presented: Electrically mediated
growth mechanisms in living systems. Sept 1973) 

WILSON DH, JAGADEESH P: Experimental regeneration in peripheral nerves and
the spinal cord in laboratory animals exposed to a pulsed electromagnetic field.
Paraplegia, 14: 12-20 (England), 1976 

YOUNG W: Pulsed electromagnetic fields (Diapulse) alter calcium in spinal
cord injury. 

Abstracts: The First International Symposium on Central Nervous System Trauma:
Restoration, Plasticity, Regeneration, 127-128 (San Francisco, CA), May 1984

60EXECUTIVE EMPLOYMENT AGREEMENT

       THIS AGREEMENT is made and entered into this 11th day of
September, 2006, by and between Cycle Country Accessories Corporation,
an Iowa Corporation, (hereinafter referred to as the "Corporation")
and Randy Kempf, of Greenwood, Indiana, (hereinafter referred to as
the "Executive").

       WHEREAS the Corporation has been actively pursuing a replacement
for its previous President and Chief Executive Officer and as such has
met with and interviewed the Executive, and is desirous of employing
the Executive in an executive and managerial capacity for the
Corporation; and

       WHEREAS the Executive is agreeable to becoming employed by the
Corporation in an executive and managerial capacity for a period of 36
(thirty-six) months and is willing to accept and undertake such
employment.

       NOW, THEREFORE, IN CONSIDERATION OF THE PROMISES AND MUTUAL
COVENANTS HEREIN SET FORTH, THE CORPORATION AND THE EXECUTIVE AGREE AS
FOLLOWS:

       1.	EMPLOYMENT. The Corporation agrees to and does hereby
employ the Executive and the Executive agrees to and does hereby
accept employment by the Corporation, in the capacity of President and
Chief Executive Officer for a period of 36 (thirty-six) months
commencing the 18th day of September, 2006 to the 18th day of
September, 2009.  This agreement will automatically be extended for
incremental thirty-six (36) month periods upon the conclusion of the
existing period, unless the Executive is unable, as provided in
sections 6 and 7 hereof, or discharged for cause, as provided in
section 8 hereof.

       2.	SCOPE OF SERVICES.  The Executive shall serve as President
and Chief Executive Officer of the Corporation. As such, the Executive
shall be in full charge of the operations of the Corporation or

<PAGE>                                 1

Corporation's business affairs, subject to the directions of the
chairman of the Board of Directors and also subject at all times to
the control of the Board of Directors.

       3.	FULL-TIME SERVICES. The Executive agrees that during the
term of his employment he will (subject to the provisions of Section 6
hereof), devote substantially all of his time and energies, during
business hours, to the supervision, management, and conduct of the
business affairs of the Corporation. The Executive will faithfully and
to the best of his ability, discharge his duties hereunder to the
furtherance of the interests of the Corporation. The Executive will
not accept other gainful employment, become or remain an officer or
director in any other Corporation, except with the consent of the
Board of Directors of the Corporation.

       4.	PLACE OF EMPLOYMENT.  The Executive will perform his
services hereunder at the principal office of the Corporation, which
is presently located at 2188 Highway 86, Milford, Iowa, or at such
other locations as directed by the Corporation.

       5.	COMPENSATION.  For all services to be rendered hereunder by
the Executive, the Corporation will pay the Executive (1) basic
current compensation; (2) bonus Compensation; and (3) fringe benefits,
as hereinafter set forth.

       A.	Basic Current Compensation  The Executive shall
(except as otherwise provided in Section 6 hereof) receive,
during the term of his employment, basic current compensation at
the rate of $187,500.00 per annum. Said amount shall be payable
in equal weekly installments. In the event the Executive's
employment is terminated by death, as provided in Section 7
hereof, the Corporation will continue to pay the Executive or his
designee, or the executor of his estate, the basic current
compensation for a period of three (3) months from the end of the
month in which such death occurs. Said amounts shall be payable
weekly.

       B.	Bonus Compensation.

<PAGE>                                 2

       1)	Signing Bonus Compensation.  The Executive shall
receive a signing bonus equivalent to $100,000.00 to be
paid in stock in the Corporation.  This stock shall be
valued at the average per share price on the day of
commencement of employment, with 25 percent issued on the
first day of employment and the remaining 75% issued in
equal increments of 25% on the anniversary date of the
commencement of employment during the next three years of
employment.

       2)	Annual Bonus Compensation. In addition to the
basic current compensation and signing bonus, the Executive
shall receive bonus compensation, which will be three
percent (3%) of the pre-tax net income in excess of the
average of pre-tax net income for the prior three years
(Fiscal 2004, 2005, and 2006).  This annual bonus
compensation shall be for fiscal year 2007 and beyond and
shall be paid in stock, cash, or a combination of stock and
cash at the discretion of the Executive.  Any portion which
is taken in stock will be valued at the average price on
the last trading day of the fiscal year.  The prior three-
year average is estimated to be approximately $1.667
million dollars and will be adjusted based on the actual
fiscal 2006 pre-tax net income.

       3)	Moving and Relocation Reimbursement.  The
Corporation hereby agrees to reimburse the Executive for
realtor's fees, attorney's fees, and other normal closing
costs associated with the sale of his existing residence,
which will be paid within 10 days of submittal of proof of
the expenses.  The Corporation will also reimburse the
Executive for actual moving costs (rental of moving van,
packing, loading and unloading - but not unpacking).  There
will be no reimbursement for the moving of RVs or similar
vehicles, with the exception of the Executive's boat and
boat trailer, which will be paid for by the Corporation, or
the Executive may choose a payment of $200.00 for excess
costs of relocation, should he elect to tow the boat and

<PAGE>                                 3

it's trailer by himself.  Normal mileage reimbursements
(.40 cents per mile) associated with the relocation, will
be paid for by the Corporation.  The Corporation will be
responsible for contracting with the moving company
directly and the payment of the moving company's invoice.

       The Corporation will further reimburse the Executive
for normal closing costs associated with the purchase of a
residence near your place of employment within 10 days of
submittal of proof of the expenses.  The Corporation will
not reimburse the Executive for any "points" or costs
associated with acquiring a lower mortgage interest rate.

       The Corporation agrees to reimburse the Executive for
temporary living costs for a place of residence approved by
the Corporation for a period not to exceed 16 weeks after
the date of commencement of employment, including mileage
and/or airfare between the Executive's existing residence
and the new or temporary residence every other weekend.  It
is understood between the parties that the Executive, upon
the acquisition of a new residence, will immediately occupy
that residence after closing and use that residence, even
though Executive's family may not relocate until near the
end of said 16 week period.  During the period of time
between occupancy of a newly acquired residence and the
actual relocation of the Executive's family to this area,
the Corporation will continue to pay mileage or airfare
back and forth every other weekend and, in addition, will
pay airfare or mileage to allow for Executive's spouse to
make 2 trips to this area during that 16 week period.  In
addition, the Corporation will gross-up on a one-time basis
and reimburse the Executive for any taxes, which become due
as a result of the moving cost reimbursement.

<PAGE>                                 4

       The Corporation agrees to pay the Executive a mortgage
interest rate differential in the event that the mortgage
on his new residence is higher than his existing mortgage
interest rate.  The Corporation will pay to the Executive
that differential based on the difference between those
rates for the first 5 years of ownership.  This interest
differential will apply to the sum of your current mortgage
(estimated to be approximately $200,000.00), plus up to an
additional $200,000.00 on the Executive's new residence in
this area.  An example:	If your current mortgage is
$200,000.00, and becomes a mortgage of $400,000.00 on a
residence purchased here, and the difference in the
mortgage rates between your current rate and new rate is
2.5%, the Corporation will pay the differential of
$10,000.00 per year, for the first 5 years, conditioned
only on your being an employee of the Corporation at the
end of each of those 5 years.

       C.	Fringe Benefits.

       1)	Health/Life/401K. The Executive shall receive
health insurance coverage for himself and all family
members, life insurance, and 401K benefits identical to
those supplied to other employees of the Corporation as
provided for in the Employee's Manual.

       2)	Sick Pay and Holidays.  The Executive shall
receive sick pay and holidays as are in effect for all
other employees with a waiver of any eligibility
requirements.

       3)	Vacation.  The Executive shall receive paid
vacation based on that provided for in the Employee Manual
for an employee with 14 years of service.  This rate is
currently 13.33 hours per month.

       6.	DISABILITY.  In the event that the Executive should become
disabled or incapacitated by illness or otherwise, for a continuous
period of not less than six (6) months, during which time he shall be

<PAGE>                                 5

unable to perform the duties required of him under this Agreement, the
Board of Directors of the Corporation, acting in good faith, may
terminate the employment of the Executive hereunder. Said termination
shall be delivered to Executive and shall specify the effective
termination of employment date, which date shall be thirty (30) days
or more from the date of such notice. No such right of termination may
be exercised, in the absence of written consent of the Executive until
after the initial six (6) months disability, unless a qualified
independent physician shall have certified that the Executive is (1)
permanently disabled or (2) incapable of resuming substantially full-
time performance of his duties, under the Agreement, for a period of
at least six (6) months after the end of his initial disability.  Said
independent physician shall be selected by the Corporation and
approved by the Executive. If the Executive is unable to give such
approval, such physician shall be approved by an adult member of his
family. In the event of termination of the Executive's employment
pursuant to this Section, the Executive shall be entitled to receive
the basic current compensation for a period of six (6) months from the
effective termination of his employment date, which date is specified
in the notice of termination contemplated by this paragraph of this
Agreement. In addition, the Executive shall be entitled to receive any
bonuses declared under the provisions of Section 5B2 hereof for the
year in which the termination occurs.  The bonuses shall be prorated
to reflect the percentage of the year that the Executive was employed.
The effective termination of employment date shall be used in
calculation of such percentage.

       EXAMPLE:

       Executive's bonus (based on calculation in Section 5B2)
       Effective date of termination of employment is April 1st.
       Executive's Bonus reduced by 50 percent

       7.	DEATH.  In the event of the death of the Executive, all

<PAGE>                                 6

compensation shall terminate at the expiration of the month of his
death, except as provided in Section 5A and except Executive's estate
will be entitled to receive bonus compensation payable pursuant to
Section 5Bb reduced to reflect the percentage of the year following
the date of death.  Said bonus compensation shall be calculated as
provided in Section 6 hereof, except the date of death shall be
substituted for the effective date of termination of employment.

       8.	TERMINATION OF EMPLOYMENT AGREEMENT.  In the event that the
Executive shall wish to voluntarily terminate this Agreement, he shall
give 180 days written notice of the Corporation of his intent to
terminate this Agreement At the time of said termination, all
compensation which the Executive is receiving pursuant to this
Agreement shall cease, except for any bonuses to be paid under the
provisions of Section 5B2 hereof for the year the year in which the
termination occurs.  The bonuses shall be prorated to reflect the
percentage of the year that the Executive was employed.  Should the
Executive terminate during the first year of his employment under this
Agreement, he shall forfeit any bonus compensation which he was
entitled under Section 5B.

       9.	DISCHARGE FOR CAUSE.  The Board of Directors of the
Corporation may discharge the Executive, before the expiration of a
contractual term of employment, for such negligence or misconduct,
either by omission or commission by the Executive, as shall constitute
as a matter of law a breach of the Executive's obligations hereunder
and would be grounds for the denial of unemployment benefits under the
laws of the State of Iowa.

       10.	INVENTIONS.  The Executive agrees, that so long as he is
employed hereunder, any and all inventions, whether patentable or not,
developed by him during the period of employment and pertaining to the
general lines of the products of the Corporation, or any of the other
involved corporations, shall be the sole property of said Corporation.
The Executive shall not be entitled to any additional compensation on
account of such inventions.

<PAGE>                                 7

       11.	COVENANT NOT TO COMPETE.  Executive agrees that he will not
compete with the Corporation, directly or indirectly, as an officer,
principal, stockholder, agent, employee or otherwise, either alone or
in association with other persons, firms or corporations, in any place
within or without the United States of America, regarding the
production, manufacture, sale or distribution of any products similar
to those produced, manufactured, sold or distributed by the
Corporation, except with the prior written consent of the Corporation.
This Agreement shall cover any period of time during which he is
receiving or is entitled to receive compensation hereunder, and also a
period of two (2) years thereafter. The Executive further agrees, that
during such periods, he will not disclose to any other person or
business entity any trade secrets or other confidential information as
to the Corporation.

       12.	SUCCESSORS AND ASSIGNS. This Agreement shall be binding
upon and inure to the benefit of the personal representatives and
successors in interest of the Executive, the personal representatives
and successors in interest of the Corporation.

       "Corporation":   Cycle Country Accessories, Corp.

                               By:  /s/ John Gault
                                    ------------------
                                    Title: Interim CEO

                                    /s/ Randy Kempf
                                    ------------------------
                                    Randy Kempf, "Executive"

<PAGE>                                 8

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