Tuesday, September 26, 2023

HealthTech Report #224: Interventional Monitoring of Muscle Reaction to PEMF Induction

Introduction: 
Test conducted on August 18, 2023. In pursuit of scientific data through independent clinical  testing, HealthTech Reporter collaborated with the Integrative Health Research Center (NYC) to conduct this private single case study and efficacy monitoring of biometric response of PEMF  frequency waves.  

Dr. Robert Bard, chief investigator designed this case study with  high resolution 3D RESONA 7 Ultrasound System by MINDRAY, NA. (complete technical info below).

The use of  of the Aurawell PEMF (AuraWave model) was applied during this test. ONE clinical participant was pre-qualified, then exposed to PEMF treatment to the QUADRICEPS muscle area for a given period of time and under a specific frequency.  The clinical imaging specialist employed various applications of a medical-grade ultrasound to monitor any visible physical reactions or movements during the time of the bioenergy treatment exposure.


PHASE 1: PREFLIGHT EXPLORATORY MICRO-TEST
Prior to launching a comprehensive device performance test, Dr. Robert Bard (and his technical team) initiates a standard short term, preflight test phase.  This cost-effective one-scan measure is an exploratory pass-fail initiator of the given hypothesis.  In this case, the client (AuraWell PEMF) wishes to record any identifiable evidence of muscle motion as a result of the PEMF frequency induction.

Strategically, the research team proceeded by testing a lower-powered PEMF model (first) called the NOVA-HD to adequately challenge the sensitivity of the ultrasound scanner(s) used in this energy induction study.  Upon treatment, the imaging technician simultaneously scanned the designated muscle with B-mode high resolution ultrasound.  Adjusting the PEMF device’s power level from 1-10, the M-mode echocardiography transducer was activated and recorded the intrinsic contraction timed to the pulse frequency.

To validate results of physiological intervention, this study is designed to detect tissue/muscular motion.  This is to be noted as intrinsic to muscular contraction and not muscle motion (generated elsewhere) such as squeezing the calf when you're looking at the thigh muscle. The imaging team employed the intrinsic echocardiogram feature called M-mode (or motion mode) to verify that the muscular contraction is occurring in the area under investigation. Echocardiographic technology is widely used to track delicate motion of the heart, muscle and valves.  Echocardiographic analysis is recognized as the most delicate way of showing (the slightest) motion.   For this, we elected to target the quadriceps muscle that was able to offer visual results when the low-powered electromagnetic pulse was activated. Experience and research indicated the muscle composition of the quadriceps has been widely studied for validating effects of other muscle therapeutic solutions (ie. neurostim, shockwave, cold laser etc). 

This exploratory phase is the pre-flight test necessary to deploy the full performance study- whereby evidence and indication of response would dictate the execution of a more comprehensive analysis and clinical review. Upon navigation of this test, the RESPONSE from this initial test showed immediate positive results (see scan diagram showing echocardiogram signal irregularity to pulse frequency).  Tissue motion is reported as being intrinsic to the pulse stimulus in the quadriceps muscle that was scanned in real time. By this micro-test, we can conclude recordable and visible muscle reaction to the pulse electromagnetic waves from this NOVA HD.  This report also extrapolates similar recordable reaction to exposure from the AURA PULSE (same brand with vastly more powerful model) to result in a similar, if not more significant effect.


PHASE 2: COMPREHENSIVE PERFORMANCE REVIEW OF THE AURA PULSE MODEL

Scan #1 of 7: PRE-TREATMENT SONOGRAM (Pre Quad) 8/18/2023 12:59:49pm

This preflight stage is a pre-treatment review using medical-grade ultrasound probe at 14 MHz frequency with 12 cm penetration and axial resolution of 0.5 mm. Conducted is a transverse scan of the quadriceps muscle. The top set of lines (labeled subcutaneous tissue). Right underneath the firm, fascia is located and between the subcutaneous fascia and the curved white bony femur outlined on the bottom is the interdigitating muscle tissues that form the four tendons of the quadriceps near the patella.


Scan #2 of 7: M-MODE ECHO-CARDIOGRAPHY (Pre Quad) 8/18/2023 1:05:39pm

Real-time scan DURING PEMF exposure
To document motion changes induced by the pulse electromagnetic pulsations, we use the motion mode setting that is used for echocardiography to demonstrate the subtlest movements in the muscle tissue inside the heart. The ammo line is seen as a white band that goes from the skin surface right down and through the curved bony portion of the femur. And the picture below this shows a steady band of horizontal lines without any motion or any change indicating that there is no contractility or motion present in the resting muscle.


Scan #3 of 7: DOPPLER/ No Flow in Box 8/18/2023 1:01:21 pm
Above the level of the femur, there's a box, which is a flow descriptor as this area is looking for arterial or venous blood flow. Notice the color bar on the top left showing directional flow where red is flow towards the probe and blue is flow away from the probe in the box. There is no evidence of color or evidence of any vessels with very low flow that may not show up that are dilated in response to the energy being put in. Hence, applying 3D Doppler Blood Flow feature of the ultrasound, we see NO blood flow or N0 Vessel dilation- indicating very low velocity that is not appearing in hemodynamic readings.
- To Be Continued - 







VISUALIZING THE TREATMENT OF INFLAMMATION
The Answers Collected from Ultrasound Imaging


Historically speaking, the most favored (and sensible) way to identify the results of any treatment is by tracking the body's immediate response to it. Controlled testing must show the patient's condition PRE and POST effects, where true data-finding is collecting the necessary EVIDENCE of its claims. The investigator can pull a significant amount of data from this form of validation testing: including stage-by-stage bodily response to future projections of possible side effects.  Modern diagnostic science looks to imaging for its safe, non-invasive yet quantifiable analyses of what’s under the skin. In this latest review, ultrasound offers a flicker-free visual (10-30 frames per second) of muscle contraction.  The “real-time” advantage of video under a 3D Doppler Ultrasound easily and clearly shows the frequency of the muscle bundle’s firing (twitching) indicating fatigue and potential pathology.


- Continued -


Scan #4 of 7: TREATMENT POWER 10/20 8/18/2023 01:05:39 pm
With the power/frequency setting of 10/20, we employed the circular transducer around the quadriceps in a 360 degree at figuration.  The motion of the muscles above this bony femur is seen to have changed from its nice, avoid appearance into something with a midline central ”waist” due to energy transfer to and within the quadriceps muscle.



Scan #5 of 7: M-MODE – PHASIC PULSATILITY NOTED 8/18/2023 01:06:56 pm
Notice the white line in the center of the switching muscle that translates into the transverse linear, and at this time, undulating or contracting muscle fibers as pointed out by the arrow at the initial pulse that reaches the muscle. Below the arrow are motion artifacts that transform the uniform, linear, horizontal lines into an unrecognized pattern of interrupted lines indicating the energy transfer and motion occurring within the muscle structure. The yellow brackets indicating pattern interruptions of muscle stasis showing visible evidence of the energy frequency induction from the PEMF.



Scan #6 of 7: DOPPLER FLOW BOX | 1.8mm VENOUS DILATION - 8/18/2023 01:11:46 pm
Measurement of a dilated vein is visually represented in this doppler flow box of the treated area between the fascia and the bone showing a dilated vein that was previously not present during pre-treatment. The vein measures 1.5 by 1.8 millimeters, and the dilatation implies blood flow of such small magnitude that it doesn't show up as a color on the registration software as the blood flow is too low. However, the fact that the veins are dilating indicates a vascular response to the energy input. The two plus marks are measurement indicators of the vein: at 1.8 mm. That's the vein that that now appeared during PEMF exposure.

Scan #7 of 7: ELASTOGRAPHY
A final (theoretical) step in this pilot study is to employ the diagnostic capacity of the elastogram feature of our ultrasound system.  In pursuit of physiological reactions to the PEMF energy induction, we may anticipate fibrosis or hardness or stiffness.  According to this scan image, we are able to capture quantitative data in the form of abnormal color which tracks with the value of the hardness or physical elastic change in the muscle fibers. The elastography scale (upper left of screen) from 100 represents very hard tissue or muscle spasm or fibrosis down to zero, indicating fat or soft tissue.  From this test, the elastogram reading shows a biometric change from 60 in hardness or spasm down to 30, representing muscle relaxation, thus adding further evidence to the PEMF effects on the condition of musculator.

CONCLUSION:  During the pre-treatment (at-rest) phase, there is no identifiable venous dilatation or blood flow. There was no muscular contractility detected by the ultra-sensitive cardiac motion mode technology.  Following a treatment at half power (10 out of 20) we can visibly and quantifiably identify that small veins are beginning to dilate and that the contractility of the tissue being energized is appearing as pulse vibrations in the form of the undulating surface line of the muscle. Measurements of change in the internal motion of the muscle fibers are outlined by the brackets (slide 5) immediately during bioenergy/electromagnetic exposure. This phase 1 test was designed to capture preliminary and evidential data of IMMEDIATE muscle/physiological reaction to energy induction therapy.  Upon further review of this quantifiable evidence and the physiological behavior of the musculature, one can extrapolate more venous dilatation and more visible blood flow activity if/when more treatment time is provided.







TECH TALK:
"Choosing The Right Scanner for My Clinical Research Project":

For this pilot study, recognized diagnostic imaging specialist Dr. Robert Bard selected the latest feature-rich MINDRAY ultrasound system: the RESONA 7. "One of my passions is learning about the latest advancements in ultrasound imaging... and thanks to a recent industry showcase, the Resona 7 stood out to me as a well-designed and highly flexible scanner that can handle the many challenges of an exploratory research project."

MANUFACTURER'S OVERVIEW:
The Mindray Resona 7 platform begins with proprietary and industry-first virtual beam-formation technology, ZONE Sonography® Technology+. The acquisition of larger and more robust acoustic data sets coupled with proprietary, industry-first virtual beamforming methods and innovative signal processing techniques translates into a number of unique imaging advantages. These include extremely fast image processing and display for noticeably improved temporal resolution; exceptional image uniformity throughout the field of view with improved spatial and contrast resolution. ZST+ also has the ability to generate novel and exclusive advanced diagnostic applications while improving the performance of established imaging technologies. Virtual beam formation will continue to shape the future of ultrasound imaging in impactful ways, allowing for more powerful technology, improved workflow tools, and the inclusion of more AI-based advancements. ZST+ has paved the way for the future of ultrasound.

Mindray’s High Fame Rate Sound Touch Elastography utilizes the advantages of ZST+ with smoother transition times and faster refresh rates for more consistent acquisition and assessment during live 2D shear wave imaging allowing for more rapid, reliable, and reproducible quantitative results.  

Advantages include:
- Patented ultra-wide beam tracking technology improves penetration, especially for stiff tumors, fatty livers, and obese patients
- Rapid acquisition with high reliability for improved efficiency and throughput
- Consistent results with high reproducibility
- Four quality measures for improved inter-operator variability and diagnostic confidence: motion stability, tissue homogeneity, reliability map, and reliability overlay visualization
- Continuous-fire STQ acquisition methods for more results in less time, enhancing the patient experience
- Combination STE and STQ mode for continuous-fire point measurement with the added advantage of quality maps 

For complete information on this technology, visit: www.MindrayNorthAmerica.com


* This clinical performance test was conducted by: Dr. Robert L. Bard of the AngioResearch Foundation and the Integrative Health Research Center for HealthTech Reporter.  Our clinical diagnostic testing team gives special thanks to MINDRAY, NA and AURAWELL PEMF for the equipment donated in the execution of this performance study- without whose generous support this study could not have been made possible.

All images, analytical content and narrative graphics presented in this report are copyright © 2023- Bard Diagnostic Imaging. All Rights Reserved.



Friday, September 1, 2023

IMAGE GUIDED APPROACH TO THE TREATMENT OF PROSTATE HYPERPLASIA

Written by: Robert L. Bard, MD

Procedurally, the best way to study an enlarged hyperplastic prostate gland is as a low grade inflammatory process, similar to women with fibrocystic breasts considered to be breast inflammation. [1] This does not need to be treated with antibiotics since this inflammation is often aligned with a chronic disease and requires a long-term treatment protocol. One example of this therapy is using a pulse electromagnetic applicator (PEMF) which can be applied over the groin area or under the pelvis (even in the car seat). For treatment applications, this protocol is recognized to be safe, painless, comfortable, and user-friendly on a long-term basis. 

Reducing low grade inflammation can be managed with relatively low energy treatment over an extended yet controlled period of time.  Daily application of energy therapy inducers to the prostate and bladder area has been proven to reduce bladder urge, the need to urinate and improve the urine flow out of the enlarged prostate. It also decreases the chance of incontinence because the bladder that is more easily emptied is less likely to overflow in an uncontrolled manner.








PEFORMANCE REPORT 1: The objective of this limited study was 2 fold: To assess for any unexpected side effects and demonstrate physical changes in the treated gland with at home PEMF treatment.   

Results: No adverse effects were reported in 3/3 subjects. 75% of the group had baseline and 30 day followup volumetric ultrasound with 3D high resolution probes and demonstrated variable volume loss. From 2 years of experience with the given PEMF device, it is understood that these technologies are not uniformly adaptable to all patient types with the uniform probe positioning for this study and limited length of time for the procedure. A full Phase 1 study with standard urologic measurements and ultrasound measurements of: 

1‐blood flow perfusion of inflammatory microcirculation
2‐elastography of physical characteristics‐scarring or fibrosis
3‐presence of macrocalculi or change in microcalculi
4‐presence of bladder pathology (stone, tumors, postvoid residual, hypertrophy) 


CASE STUDY 1: Caucasian male, 69 years old 

SONOGRAM: RE+ right psa elevated  Comparison 7/5/23 1 month PEMF 

TIME OUT: risks/benefits/possibility of false positives discussed 

Prostate, bladder and pelvic paraprostatic  spectral Doppler vascular study was performed using  transrectal 4D  real  time b mode examination, power Doppler, spectral flows and 3D workstation analysis. This report sequence was limited to volumetric changes based on non invasive therapies.  Dre=+/‐ left  

PROSTATE VOLUME:
Base line: Previous pre‐treatment prostate vol: 104cc
After Exposure Effect: Current post treatment prostate vol: 92cc 

Vascular area: r lateral 9x7 prev 9x7 mm.  VI=1%  unchanged Vessel Index is a quantitative measure of inflammatory or malignant vessels.  Note the absence of increased vascularity in the 9x7 mm focus signifies no evidence of abnormally induced vessel related adverse effects over the one month study period.

OVERVIEW OF ENERGY INDUCTION: Both benign enlargement and increased incidence of cancer are associated with micro inflammation.  PEMF therapy may result in a reduction in kidney obstruction, a decrease in urinary symptoms and a reduced incidence in cancer as a benefit of routine use may be forthcoming.


 
PSA READINGS vs IMAGING

In 1930, the PSA was developed by the University of Arizona as a rape test. It was accurate for finding and identifying semen in rape victims but it was never made to be diagnostic for prostate cancer. The 2004 Journal of Urology stated the PSA is 2% accurate in diagnosing prostate cancer definitively, which means that the digital rectal exam is at least three times more accurate than the PSA blood test in finding clinical prostate cancer. Also, in benign diseases such as prostatitis or benign enlargement with older age, the PSA level automatically rises in most patients. Therefore, the PSA lifespan has ended, much like the x-ray has ended in the use of prostate disease because we use CT MRI and ultrasound.  CT and MRI is being replaced by the imaging community is now trending to substitute 3D Doppler and elastography to scan the prostate for prostate cancer aggression and capsule integrity worldwide [4].


PEMF FOR PROSTATE HEALTH
Current research reports show that PEMF has been applied clinically in prostate therapeutic treatments [2,3]. Under the philosophy of inflammation reduction, our pilot study was designed to test PEMF performance and the patient's physiological reaction before and after treatment as we are evaluating the treatment effect in real time. 

Because we are able to calibrate the strength of the prostate bioenergy entering the body by monitoring the autonomic nervous system we were able to fine tune the therapeutic process.  So far we are having measurable success in positively addressing symptoms and (hopefully) will have proven over time a long term goal that reducing prostate inflammation also reduces the incidence of clinical prostate cancer.

It is important to note that low grade inflammation is oftentimes a precursor or potentially mixed with cancers. The possibility of reducing prostate cancer risk by using post bioenergy noninvasive protocols is something that makes clinical sense and has been widely used in other countries [5,6]. Upon the strategic design of our current pilot study, we hope to expand the scientific findings of this protocol to lead to greater use of non-invasive pulsed energy solutions for prostate and allied health problems.


References: 

1) "Enlarged Prostate" - PennMedicine.org https://www.pennmedicine.org/for-patients-and-visitors/patient-information/conditions-treated-a-to-z/enlarged-prostate#

2) "Effect of Pulsed Electromagnetic Field Therapy on Prostate Volume and Vascularity in the Treatment of Benign Prostatic Hyperplasia: A Pilot Study in a Canine Model" | National Institutes of Health.- PMID: 24913937- Raffaella Leoci,* Giulio Aiudi, Fabio Silvestre, et al.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4145661/

3) "Therapeutic use of pulsed electromagnetic field therapy reduces prostate volume and lower urinary tract symptoms in benign prostatic hyperplasia"- PMID: 32090492 |  Marta Tenuta, Maria G Tarsitano, Paola Mazzotta et al. https://pubmed.ncbi.nlm.nih.gov/32090492/

4) "Ultrasound & The Prostate": RadiologyInfo.org |  https://www.radiologyinfo.org/en/info/us-prostate#:~:text=Ultrasound%20of%20the%20prostate%20uses,whether%20the%20gland%20is%20enlarged.

5) "Prostate cancer ultrasound treatment as effective as surgery or radiotherapy", by Kate Wighton (04 July 2018). Imperial College London. https://www.imperial.ac.uk/news/187086/prostate-cancer-ultrasound-treatment-effective-surgery/

6) "Mechanisms and therapeutic effectiveness of pulsed electromagnetic field therapy in oncology"- 2016 Nov 5, | PMID: 27748048 | Maria VadalĂ , Julio Cesar Morales‐Medina, Et. Al. - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5119968/



ASSOCIATE CONTRIBUTOR:

Dr. JERRY DREESSEN is both Trauma Team Qualified and Hospital Qualified treating chiropractor in Mountlake Terrace, WA. He is the Executive Director for the Association of PEMF Professionals- the largest professional PEMF organization in the United States. AOPP attracts the most principled and accomplished PEMF user- setting standards by providing certification for all PEMF users, as well as Continuing Education (CEU's) for all members to maintain best practices and techniques. (www.backtoaction.com)



SPECIAL THANKS
The news feature proudly gives thanks to the AOPP (Association of PEMF Professionals) and Patrick Ziemer of Magnawave Inc. and Aura Wellness PEMF for the technical information provided for interviews and unending support to support our clinical study and educational programs about PEMF technology for chronic disorders and supportive testimonials in alternative therapeutics.   Additional special thanks to Dr. Robert Bard and  "Cousin Sal" Banchitta and Russ Allen (Wellness NOW!) for their proactive leadership in support of men's health in this review under the "Get Checked NOW!" advocacy program. 

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