Ultratone Paper.pages

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An Innovative Non-Surgical System for Body Contouring,
Cellulite Reduction, and Improved Health
Gregory Chernoff, M.D., F.R.C.S.(C)
Chernoff and Associates Cosmetic Surgery, Laser, and Wellness Centers
ABSTRACT
Non-surgical body sculpting systems have attempted to implement lasers, radio frequency, infrared
energy, ultrasound, and cryotherapy, to disrupt the adipose cell membrane in hopes of causing
circumferential reduction. Our center studied a novel bimodal instrument to test the safety and efficacy
for patient use. We examined both the physical and psychological changes in each patient.
BACKGROUND
There have been many non-surgical bodycontouring systems introduced over the past
ten years. These systems have attempted to
implement lasers, radio frequency, infrared
energy, ultrasound, and cryotherapy, to
disrupt the adipose cell membrane in hopes of
causing circumferential reduction.
Results have varied from poor to fair, with
good physiological explanation. Once the fat
cells have been disrupted, the assumption was
made that the patient’s body would excrete
the resultant triglycerides and fatty acids.
Little evidence exists that this was the case.
OBJECTIVE
A novel bimodal instrument is studied. First, a hand
held ultrasound transducer generating 1 Mhz is
utilized to emulsify fat in a specific treatment area.
Immediately afterwards, the application of muscle
biostimulation is performed, targeting the same
specific treatment area.
It is hypothesized that the deep muscle stimulation
creates a scenario of energy consumption, allowing
the released triglycerides to be consumed by the
body. The aim of this study is to examine BMI,
circumferential reduction, cellulite reduction,
muscle toning, skin tightening, longevity of results,
and hematological tests before and after treatments
are completed.
Chernoff Cosmetic Surgery, Laser, and Wellness Center
Contact: [email protected] Indianapolis, IN: 317.573.8899 Santa Rosa, CA: 707.544.3232
©2014 All Rights Reserved.
CLINICAL RESEARCH
METHODS
Fifteen patients underwent a series of six
treatment sessions, spaced one week apart.
Each treatment consisted of thirty minutes of
ultrasound therapy, followed by thirty minutes
of electrical muscle biostimulation.
Pre-treatment measurements, weight and
photographs were taken. Pre-treatment
hematology examined Triglycerides,
Cholesterol, LDL, HDL, Glucose, and CReactive Protein. The same blood draw was
performed after the sixth session. Patients
were re-examined six months and one year
after treatment.
RESULTS
All enrolled patients experienced
circumferential reduction in the areas treated.
Patients with higher BMI’s at initiation saw
proportionately greater losses than those with
smaller stature. Patients treated for unwanted
cellulite, muscle toning and skin tightening,
expressed “high satisfaction” on linear analog
scores. Of particular interest were the
associated improvement in health parameters.
All patients had a reduction in Cholesterol.
Triglycerides and Glucose levels. LDL
decreased, while HDL increased. Longevity at
six months to one year is statistically valid.
CONCLUSION
The FuturoPro offers a unique addition to the
armamentarium of non-surgical body sculpting
therapies.
INTRODUCTION:
The medical aesthetic industry has seen a
significant growth in minimally or non-invasive
energy based body shaping systems. While
surgical options remain the gold standard in
most cases, the latest less invasive technologies
and products have shown progressive
improvement over earlier generation systems.
Herein lies the dilemma. Human nature has
shown that patients prefer a “quick fix”,
preferably non-surgical, largely due to the
popular negative misconceptions surrounding
the word “surgery”. If they are then told that the
non-surgical options provide a viable alternative,
the resultant expectations are often those of the
results that surgical options, (liposuction or
abdominoplasty) can yield. This is simply not
the case. However, when positioned properly,
giving patient’s realistic expectations, high
levels of satisfaction can be achieved.
Greg Chernoff, M.D., F.R.C.S.(C)
The non-surgical systems attract patients who
may be fearful of surgery, cannot afford surgery,
or those for whom medical conditions, yield
surgery as a non-option. To date, several
technologies have been attempted. These have
employed methods to disrupt the integrity of the
fat cell either reducing the size of the fat cell or
interrupting the cell wall with resultant leakage
of fatty acids and triglycerides. The most
popular technologies consist of ultrasound,
radiofrequency(RF), laser and cold energy,
radial shock waves and magnetic pulse therapy.
All of these systems have a physiological flaw.
While they all, to varying degrees, cause
damage to the fat cell, they all rely on the
patients’ body to remove the byproducts, a
hypothesis that is flawed, if nothing changes
physiologically for the patient, ie: diet, exercise.
This is the flaw with these systems.
Chernoff Cosmetic Surgery, Laser, and Wellness Center
©2014 All Rights Reserved.
CLINICAL RESEARCH
The Futura Pro addresses excess fat, cellulite,
skin elasticity, and muscle tone, from a
physiological perspective. The deep ultrasound of
1 MHz frequency creates acoustic and thermal
damage to the fat cell wall. This yields a release
of fatty acids and triglycerides. The muscle
stimulation creates a negative energy scenario for
which the exhausted muscles seek fuel…namely
the released fatty acids and triglycerides. The net
effect is reduction of fat, increased muscle tone,
and improvement in the appearance of cellulite. It
is the bimodal function of the Futura Pro which
theoretically sets it apart from competitors. The
ability to stimulate muscle contraction to
exhaustion enables the consumption of the
released fat byproducts which does not happen
with any of the existing systems available on the
market.
PATIENTS AND METHODS:
From January, 2014 to March 2014, 15
consecutive patients (13 female, 2 male), were
treated with the Futura Pro System. Ages ranged
from 24 to 58. BMI ranged from 21.5 to 34.2
with a mean of 27.5. Patients were treated weekly
for six weeks. Photographs were taken before and
after each treatment. Patients were weighed and
measured before and after each treatment.
Measurements were standardized and described
as Abdomen High, Abdomen Navel, and
Abdomen Low.
Each treatment consisted of thirty minutes of
ultrasound, followed by thirty minutes of muscle
stimulation. The diathermic ultrasound signal is
delivered via an acoustic coupling gel. The
ultrasound applicator has all the necessary
controls (on/off amplitude) in the handset and
derives only a time controlled power source from
the main control unit. The muscle stimulation
component consists of a main control unit which
powers and controls a separate stimulator that
repetitively contracts skeletal muscles by
applying transcutaneous electrical pulses to areas
of the body that require therapy for the indicated
conditions.
Greg Chernoff, M.D., F.R.C.S.(C)
These pulses for muscle stimulation are
applied via self-adhesive electrodes applied on
the skin. Set programs with predetermined
parameters are selected by the operator. On
screen instructions guide the user, displaying
numbered programs, indication of intensity
levels, adjustments, and treatment use. The
output leads have indicator LED’s identifying
each output as the electrodes are positioned
and the intensity is adjusted.
Each patient consented to the following
hematological tests. Serum Triglycerides,
Cholesterol, HDL, LDL, Glucose,
Homocysteine, and C-Reactive Protein were
drawn Pre Treatment, Post Ultrasound, and
Post Muscle Stimulation. Patients were
followed for six months, and follow-up
parameters examined.
RESULTS:
Patient measurements are summarized in
Table 1. Hematological results are
summarized in Table 2. Patient photographs
with individual summaries are found in
Table 3.
All but one patient lost weight ranging from 1
pound to 14 pounds with a mean of 7.1
pounds. All but one patient decreased
abdominal girth measurements. High
abdomen losses ranged from 0.5 cm to 14 cm
with a mean of 5.4 cm. Abdominal umbilical
losses ranged from 0.6 cm to 14 cm with a
mean of 5.4 cm. Low abdominal losses ranged
from 0.9 cm to 12 cm with a mean of 5.3 cm.
Hematological results proved interesting. The
majority of patients had a reduction of
Triglycerides, Cholesterol, LDL, and Glucose.
HDL showed little change, or increased in
some patients. Homocystein and C-Reactive
Protein were reflective of muscle stimulation
and muscle building.
Chernoff Cosmetic Surgery, Laser, and Wellness Center
©2014 All Rights Reserved.
CLINICAL RESEARCH
Of particular interest was the psychological
profiles of the study participants. There was a
direct correlation between weight reduction
and circumferential reduction with the
motivation, dietary modification, exercise
participation, and psychological support
extended to the participants.
Intuitively, it makes sense that if we simply
damage a fat cell, causing the release of fatty
byproducts, our bodies can only excrete a
certain amount. Additionally, if the lifestyle of
the patient in question does not change for the
better relating to diet and exercise, then why
will anything change?
Six month follow-up showed a correlation
between maintenance of circumferential
reduction and the maintenance of a diet that
successfully reduces caloric intake, as well as
lifestyle interventions that promote behavioral
changes to support adherence to a calorierestricted, nutrient dense diet.
The Futura Pro has shown to provide effective
ultrasonic fat cavitation, fat breakdown and
intense muscle activation, with subsequent
circumferential reduction. The concurrent
muscle stimulation, rendering the muscles
exhausted, create the scenario of muscle
seeking fuel, which has been presented to the
muscle by the ultrasonic cavitation of fat
yielding fatty acids and glycerol for energy
attainment by the hungry muscles. The net
effect is loss of fat, and increase in muscle
tone.
The psychological support provided to the
patient by loved ones also has been shown to
play a significant role in the success of any
program.
DISCUSSION
The obesity epidemic has fostered the
development of numerous non-surgical
systems heralding weight loss, circumferential
reduction and improvement in resultant skin
quality. Human nature being what it is, fosters
interest in these treatments by those afflicted
for the same reasons they are obese. They want
an easy solution, with little to no effort on their
part to effect behavioral changes, ie. Exercise
and diet; that would be conducive to better
health.
The past five years have yielded the
emergence of laser, RF, ultrasound, cavitation,
and cryolipolysis technologies to attempt to
help these patients who may not otherwise be
surgical candidates for health, psychological or
monetary reasons. Long-term results from the
aforementioned systems are lacking in the
literature. There are many papers discussing
the short-comings.
Greg Chernoff, M.D., F.R.C.S.(C)
The long-term maintenance of the results… or
lack thereof, is directly proportional to the
motivation possessed by the patient relating to
the maintenance of a nutrient rich diet and
regular exercise program. These parameters
have a greater chance of success IF the patient
has a strong psychological support system to
offer accountability.
CONCLUSION:
The Futura Pro dual modality therapeutic fat
reduction system offers a viable and
efficacious addition to the armamentarium of
the physician involved in the treatment of
those patients afflicted with obesity or those
seeking to reduce selected fatty areas, increase
muscle tone, or improve their health relating to
those hematological markers lending to
morbidity.
Chernoff Cosmetic Surgery, Laser, and Wellness Center
©2014 All Rights Reserved.
CLINICAL RESEARCH
Table 1. Hematological Results
Greg Chernoff, M.D., F.R.C.S.(C)
Chernoff Cosmetic Surgery, Laser, and Wellness Center
©2014 All Rights Reserved.
CLINICAL RESEARCH
Greg Chernoff, M.D., F.R.C.S.(C)
Chernoff Cosmetic Surgery, Laser, and Wellness Center
©2014 All Rights Reserved.
CLINICAL RESEARCH
Table 2 - Patient Measurements
Greg Chernoff, M.D., F.R.C.S.(C)
Chernoff Cosmetic Surgery, Laser, and Wellness Center
©2014 All Rights Reserved.
CLINICAL RESEARCH
Greg Chernoff, M.D., F.R.C.S.(C)
Chernoff Cosmetic Surgery, Laser, and Wellness Center
©2014 All Rights Reserved.
CLINICAL RESEARCH
Table 3 - Patient Photographs & Measurements
Greg Chernoff, M.D., F.R.C.S.(C)
Chernoff Cosmetic Surgery, Laser, and Wellness Center
©2014 All Rights Reserved.
CLINICAL RESEARCH
Greg Chernoff, M.D., F.R.C.S.(C)
Chernoff Cosmetic Surgery, Laser, and Wellness Center
©2014 All Rights Reserved.
CLINICAL RESEARCH
Greg Chernoff, M.D., F.R.C.S.(C)
Chernoff Cosmetic Surgery, Laser, and Wellness Center
©2014 All Rights Reserved.
CLINICAL RESEARCH
Greg Chernoff, M.D., F.R.C.S.(C)
Chernoff Cosmetic Surgery, Laser, and Wellness Center
©2014 All Rights Reserved.
CLINICAL RESEARCH
Greg Chernoff, M.D., F.R.C.S.(C)
Chernoff Cosmetic Surgery, Laser, and Wellness Center
©2014 All Rights Reserved.