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PULSED RADIO FREQUENCY ENERGY AND PULSED LED THERAPY FOR PAIN MANAGEMENT, INFLAMMATION, TISSUE REPAIR AND WOUND HEALING

 

Dr Kiril A. Pandelisev, Sc.D.

MEDICAL APPLICATIONS OF SHORTWAVE RADIO FREQUENCY

 

Therapeutic medical application of radio frequency (RF) energy at a carrier frequency between 13–27.12MHz is referred to as shortwave diathermy and can be divided into two general categories based on mode of delivery: continuous RF energy delivery and pulsed RF energy delivery. Continuous delivery of shortwave energy to a tissue leads to an increase in tissue temperature, and is used for the therapeutic delivery of deep heat. Delivery of pulsed RF energy to a tissue can allow for the dissipation of heat between pulses, providing therapeutic effects in the absence of substantial tissue temperature elevation, a therapy first developed to diminish negative complications that can occur with tissue heating, while conserving other therapeutic benefits of this type of application. While tissue heating with pulsed RF energy is deemed to be insignificant, new research suggests that there is a thermal component to pulsed RF energy which may offer significant therapeutic effects on soft tissues. Pulsed RF energy has a wide range of therapeutic uses, is well tolerated due to the non-invasive nature of application, and serves as an effective adjunctive treatment for many conditions. Non thermal therapeutic uses of pulsed radio frequency are currently being used to treat pain and edema, chronic wounds, and bone repair.

 

Pulsed radio frequency electromagnetic field therapy (PRFE), or pulsed electromagnetic field (PEMF) therapy has a long history in treating medical conditions. In 1947 the Federal Communications Commission assigned three frequencies at the short end of the RF band for medical use (40.68 MHz, 13.56 MHz and 27.12 MHz). The frequency of 27.12 MHz is the most widely used in clinical practice. The first PRFE device, the Diapulse (Diapulse Corporation, NY) was commercially available in the 1950’s, and was followed by other commercially available machines. PRFE is a non-invasive therapy that delivers electromagnetic energy into soft tissue generating an electric field which is thought to mediate the therapeutic effects. Our range of pulsed radio frequency electromagnetic energy devices operate in the shortwave form of 27.12Mhz. Other frequencies have also been considered in the patent.

 

THERMAL COMPONENT OF PULSED RADIO FREQUENCY ENERGY THERAPY

 

The peripheral neural system is now known to be highly temperature sensitive, and many other specific sites and mechanisms of thermal sensitivity have been identified. Temperature increases in tissues as low as 0.1oC have significant biological affects which include:

 

1. Vasodilation

2. Increased rate of cell metabolism

3. Increased capillary permeability

4. Increased delivery of leukocytes

5. Removal of metabolic waste

6. Increased elasticity of ligaments, capsules, and muscle

7. Analgesia and sedation of nerves

8. Increased nerve conduction

9. Decrease in muscle tone

10. Decrease in muscle spasm

 

The early development of RF energy application was termed diathermy, which literally means heating through. Termed, because unlike externally applied heat the RF energy is able to penetrate relatively deep into soft tissue resulting in a deep heating effect. Pulsing was introduced to eliminate these heating effects and reduce the adverse effects of heat induced tissue damage. However, pulsing the RF energy has proven to eliminate thermal damage a thermal therapeutic effect cannot be ruled out. Recent research suggests that a thermal component of pulsed RF energy may still be a factor in the therapeutic effects of PRFE. With respect to the effects of pulsed shortwave diathermy, there is an element of tissue heating which occurs during the `on' pulse, but this is dissipated during the prolonged ‘off' phase. Clearly during the delivery of each pulse there will be a (very small) thermal change and the potential thermal effect of pulsed short wave is dependent on 3 parameters:

Figure 1.     Pulse parameters and their definitions. Repetition Rate (Hz or pps) is the number of pulses delivered per second; Pulse Duration (Width) is the duration time of each ‘ON’ phase: Peak is the energy delivered during the pulse. Mean Energy is the average energy delivered per time cycle. Peak power is the power level of the device during the ON time, while Mean Power is the average power used during the cycle.

 

 

Figure 1.     Example of no thermal build up pulse rate

 

Fig. 3      Example a high pulse rate results in a non-thermal and thermal build up.

 

The externally applied continuous application of low level heat has recently shown to be therapeutically effective in a series of clinical studies. However, externally applied low level heat results in minimal deep tissue heating. Pulsed RF as a continuous application is able to apply physiologically significant levels of heat deep into the target tissue, without corresponding negative effects of thermally induced tissue damage. The dual thermal and electrical therapy of pulsed RF electromagnetic energy provides a unique dynamic approach to pain reduction and the acceleration of healing.

 

PHASES OF HEALING

Figure 4.     Approximate times of the different phases of wound healing,with faded intervals marking substantial variation, depending mainly on wound size and healing conditions, but image does not include major impairments that cause chronic wounds.

 

NON-THERMAL MECHANISM OF ACTION OF PULSED RADIO FREQUENCY ELECTROMAGNETIC FIELD

 

The mechanism of action of Pulsed Radio Frequency Electromagnetic Field (PRFE) on wound healing and control of pain is beginning to be understood based on a number of cell and animal studies. The mechanism of Ca2+ calmodulin signaling leading to nitric oxide (NO) production is covered by a review article Strauch et al (2009 and a figure from the article is presented below.

 

Figure 5.       A proposed model for Pulsed electromagnetic field (PEMF) transduction mechanism based on evidence to date that many athermal PEMF effects depend upon nitric oxide cascades. PEMFs can be configured to modulate calcium-binding kinetics to calmodulin. Calcium/calmodulin then activates nitric oxide synthase and the relevant cascade ensues dependent upon stage of tissue repair process. This mechanism has been proposed as a working model for PEMF therapeutics.

 

A number of cellular studies show PRFE has effects on production of nitric oxide (Diniz, Soejima et al. 2002; Kim, Shin et al. 2002; Fitzsimmons, Gordon et al. 2008; Yue, Yang et al. 2008; Lee, Kwon et al. 2010), increased cell proliferation (Diniz, Soejima et al. 2002; Kim, Shin et al. 2002; Fitzsimmons, Gordon et al. 2008; Yue, Yang et al. 2008; Lee, Kwon et al. 2010), and in vivo vasodilation in the muscle (Smith, Wong-Gibbons et al. 2004). It is known that NO is a critical molecular signal and mediator for normal wound healing (Boykin 2010; Filippin, Cuevas et al. 2011), and NO deficiency has been established as an important mechanism responsible for poor healing in diabetic foot ulcer patients (Filippin, Cuevas et al. 2011). Co-cultures of human dermal fibroblasts and human epidermal keratinocytes exposed to PRFE demonstrated an up-regulation of gene families involved in tissue repair. These include matrix metalloproteinase (MMP,s) and tissue inhibitor of metalloproteinase (TIMP’s), and cytokines - interleukin (IL)-related genes, interferon (INF)-related genes, and tumor necrosis factor (TNF)-related genes (attached).

 

Fig. 6.      Co-cultures of human dermal fibroblasts and human epidermal keratinocytes exposed to PRFE demonstrated an up-regulation of gene families involved in tissue repair.

 

The growth factor, fibroblast growth factor-2 (FGF-2) has also been shown to be upregulated by PRFE treatment. FGF-2 promotes endothelial cell proliferation and the physical organization of endothelial cells into tube-like structures, thus promoting angiogenesis. As well as stimulating blood vessel growth, FGF-2 is important player in wound healing, stimulating proliferation of fibroblasts and endothelial cells that give rise to angiogenesis, and developing granulation tissue as well as increasing blood supply. A number of animal and cell studies have demonstrated FGF-2 up-regulation after PRFE treatment. In a mouse model of diabetes, PRFE treatment improved healing with the up-regulation of FGF-2 and was able to prevent tissue necrosis in diabetic tissue after an ischemic insult (Callaghan, Chang et al. 2008).

 

Angiogenesis mediated by FGF-2 up-regulation as well as angiopoietin-2 was reported in bones of mice treated with PRFE (Goto, Fujioka et al. 2010). A study on endothelail cells treated with PRFE also demonstrated a FGF-2 up-regulation and increased endothelial tubular formation with the effects mitigated by FGF-2 neutralizing antibody (Tepper, Callaghan et al. 2004).

 

Though not significant, FGF-2 was shown to be up-regulated in wounds after breast reduction surgery (Rohde, Chiang et al. 2010). Taken together these studies indicate that PRFE therapy can up-regulate mechanisms involved in tissue repair including growth factors and cytokines

important for the wound healing process.

 

The medical applications of PRFE therapy has recently been well reviewed by Guo et al (Guo, Kubat et al. 2011).

 

EXPERIMENTAL REALIZATION OF PRFE AND PEMF APPARATUS.

 

To date, all radiation devices consist of rather large by size and with complex electronics that might or might not supports more than one radiation device. Since radio waves are electromagnetic waves, one may consider PRFE and PEMF to be all electromagnetic treatments. The signal strength and the energy delivery determine the time span of the healing process.

 

Also, the wound is exposed to whatever EM profile and strength the machine can produce. All devices work on one fixed frequency. They are all not body friendly. No data collection, data storage and data transmission is possible with all of the devices seen below.

 

a.  A fixed clinic based PRFEdevice with a daily 2 x 30 mintreatment regime b.  Suit case sized device offering portability with treatment regimens of 2x 30 min daily.c.  Wearable PRFE device weighing 8g which operates for 1 week of continuous therapy.

Fig. 7. Examples of experimental realization of PRFE healing apparatus.

 

While the understanding of the healing process over the last 10 years was exponential, the outcome remains within the initially published data by Diapulse Inc.

 

1. The irradiated area is either too large or too small for the wound heated

2. Skin heating and burning remains an issue

3. No feedback sensors of any kind

4. No control over the field strength over the treated area.

5. Bulky and costly devices.

6. No field and radiation energy data bank for doctors’ analysis and comparison with wound healing.

7. Not practical for remote applications, despite their semi portability.

8. Not user friendly by any means.

 

Fig. 8     A fixed clinic based PRFE device with a daily 2 x 30 min treatment regime

 

New and improved technology that tailors to the wound can treat more than one wound on the body at the same time, and that resolves all of the issues listed above. Pandelisev through his granted and pending patents offers solutions and more.

 

MULTIPLE SELECTABLE PRFE ARAY HAVING INDIVIDUALLY POWERED AND CONTROLLED CELLS

 

Pandelisev’s approach combines the PRFE and PEMF and adds physical and user flexibility to the all devices. The benefits of this technology are as follows:

 

1. Devices are lightweight,

2. Can be wired or wireless,

3. Flexible with body molding capabilities.

4. Cell based radiation sources and makes them suitable for any applications.

5. Embedded LED technology among the EM sources for faster healing

6. Embedded sensors at various key points in the pad

7. It offers simultaneously various field strengths and various frequencies over the area being treated.

8. Each cell has independent wireless filed strength and frequency control.

9. Solar battery charging

10. Portable for use elsewhere

11. Offers use during or between various activities such as camping, hiking, traveling, exercising, and any other activity the patient is involved in.

12. Dynamic use of the device increases its usefulness as a pain management and healing process.

 

Graphic presentation of the device field strength, field type and frequency is as presented below in Figures 9-15. One can easily see that different parts of the wound cab be treated by different doses and frequencies. The center of the wound that is more traumatized than the rest can heal at the same rate as the other less traumatized parts. This is expected to speed up the healing process and offer less scarring at the wound site.

 

The device also offers localized treatment. This is especially important when one treats facial areas for beautification or healing surgical cuts. The cells over the eyes and other sensitive parts of the body can be turned off. Treatment of the area around the eyes is made safer simply by not exposing them to unwanted RF radiation. Many RF lasers today can cause serious burn damage and they also require doctor’s supervision. The process combination between RF and infrared LED’s our devices employ is as shown below. All for home and salon use, no doctor required.

 

Fig. 9     Graphical presentation of the field effects of individual cell with RF and RF + IR pulsed energy radiation.

 

Figure 10.    Pandelisev’s Multiple selectable pulsed RF healing apparatus and example of wound that can e treated with this unit. Each cell can offer Variable Field Strength and Variable Frequency

 

Figure 11.     Wound healing configuration that provides for Variable Filed Strength and Variable Frequency over the wound area. Different cells provide chosen field strength and frequency.

 

Figure 12.     Wound healing configuration that provides for Constant filed Strength and Variable Frequency over the wound area. Different cells provide chosen field strength and frequency.

 

Figure 13.    Wound healing configuration that provides for Variable filed Strength having Variable Frequency over the wound area. Different cells provide chosen field strength and frequency.

 

Contrary to the rigid control systems shown in Figure 7, our devices are state of the art and very user friendly. They offer wound documentation via photo and PRFE data applied and the total energy delivered. The wireless mode offers communication with the doctor’s office within or outside the hospital. User friendly device offers for treatments at home or office or gym, and for monitoring of the same treatments from the doctor’s office via internet. The device comes with hardware that can be used for social and business application while the wound or injury or pain center treatment occurs. Example control devices and possible body applications are as displayed but not limited to those shown in Figure 14.

 

The device may take the shape of the body treated. Collage of various sports and orthopedic shapes is as shown below. This can be done in collaboration with existing makers of such devices.

 

All devices intended for beauty and pain do not require doctor’s presence or prescriptions. Salons, Beauty shops, sports centers, gyms, they can all own and operate them.

 

Figure 14.     Example of control devices for Pandelisev’s device. Many other control configurations have been considered.

 

 

Fig.15.      Suggested initial applications via augmenting existing products or designing new ones to better suit the particular application.

 

 

References

Boykin, J. V., Jr. (2010). "Wound nitric oxide bioactivity: a promising diagnostic indicator for diabetic foot ulcer management." J Wound Ostomy Continence Nurs 37(1): 25-32; quiz 33-24.

Callaghan, M. J., E. I. Chang, et al. (2008). "Pulsed electromagnetic fields accelerate normal and diabetic wound healing by increasing endogenous FGF-2 release." Plast Reconstr Surg 121(1): 130-141.

Diniz, P., K. Soejima, et al. (2002). "Nitric oxide mediates the effects of pulsed electromagnetic field stimulation on the osteoblast proliferation and differentiation." Nitric Oxide 7(1): 18-23.

Filippin, L. I., M. J. Cuevas, et al. (2011). "Nitric oxide regulates the repair of injured skeletal muscle." Nitric Oxide 24(1): 43-49.

Fitzsimmons, R. J., S. L. Gordon, et al. (2008). "A pulsing electric field (PEF) increases human chondrocyte proliferation through a transduction pathway involving nitric oxide signaling." J Orthop Res 26(6): 854-859.

Goto, T., M. Fujioka, et al. (2010). "Noninvasive up-regulation of angiopoietin-2 and fibroblast growth factor-2 in bone marrow by pulsed electromagnetic field therapy." J Orthop Sci 15(5): 661-665.

Guo, L., N. J. Kubat, et al. (2011). "Pulsed radio frequency energy (PRFE) use in human medical applications." Electromagnetic biology and medicine 30(1): 21-45.

Kim, S. S., H. J. Shin, et al. (2002). "Enhanced expression of neuronal nitric oxide synthase and phospholipase C-gamma1 in regenerating murine neuronal cells by pulsed electromagnetic field." Exp Mol Med 34(1): 53-59.

Lee, H. M., U. H. Kwon, et al. (2010). "Pulsed electromagnetic field stimulates cellular proliferation in human intervertebral disc cells." Yonsei Med J 51(6): 954-959.

Nicolle, F. V. and R. M. Bentall (1982). "Use of radio-frequency pulsed energy in the control of postoperative reaction in blepharoplasty." Aesthetic Plast Surg 6(3): 169-171.

Rawe, I. M. and T. C. Vlahovic (2011). "The use of a portable, wearable form of pulsed radio frequency electromagnetic energy device for the healing of recalcitrant ulcers: A case report." Int Wound J.

Rohde, C., A. Chiang, et al. (2010). "Effects of pulsed electromagnetic fields on interleukin-1 beta and postoperative pain: a double-blind, placebo-controlled, pilot study in breast reduction patients." Plast Reconstr Surg 125(6): 1620-1629.

Smith, T. L., D. Wong-Gibbons, et al. (2004). "Microcirculatory effects of pulsed electromagnetic fields." J Orthop Res 22(1): 80-84.

Strauch, B., C. Herman, et al. (2009). "Evidence-based use of pulsed electromagnetic field therapy in clinical plastic surgery." Aesthet Surg J 29(2): 135-143.

Tepper, O. M., M. J. Callaghan, et al. (2004). "Electromagnetic fields increase in vitro and in vivo angiogenesis through endothelial release of FGF-2." FASEB J 18(11): 1231-1233.

Yue, A., G. Yang, et al. (2008). "[The influence of the pulsed electrical stimulation on the morphology and the functions of the endothelial cells]." Sheng Wu Yi Xue Gong Cheng Xue Za Zhi 25(3): 694-698.

Pandelisev, Kiril A (2007). “Multiple Selectable Field Current Voltage Pads Having Individually Powered and Controlled Cells,” US Patent 7,177,696 B1, 2007.

About H&P Medical Research Inc,

H&P Medical Research, Inc. is a privately held medical technology company focused on developing and marketing proprietary technology and products for use in wound healing, pain management and tissue repair.

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