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THE EFFECT OF ELECTRIC STIMULATION
OF FACIAL MUSCLES WITH “TUA VISO”
FOR THE TREATMENT OF WRINKLES


Ugo DeSantis, Paolo Gottarelli, Luciano Merlini, Giuseppe Monetti, Stefano Righini.

INTRODUCTION

There are no wrinkles on the faces of newborn babies; wrinkles disappear when a face is
Paralyzed, but wrinkles remain after death.  This therefore represents a process linked with the face’s muscular activity, which people find particularly unattractive from the age of forty onwards. It is well-known that electric stimulation can increase the muscular tone of the trunk and limbs and reduce the layer of subcutaneous fat more than physical exercise and massages (Heyters & Spierckel, 1987).
VUPIESSE ITALIA has manufactured a battery-powered electric stimulator unit (“TUA”) which generates a 80 cycles/sec. electronically modulated current in which the pulse length is the same as that of high frequency current (over 4500 cycles/sec.), so muscular contraction (motor/stimulant effect) is achieved before pain is felt.  It is a compact portable unit specifically designed for the stimulation of facial muscles, which can be done safely and effectively without causing pain.
It is believed that this type of treatment is effective when used constantly for a long period of time and that results are only noticeable after months.  This delay between starting treatment and the appearance of the desired effect is a possible obstacle when choosing this non-invasive technique instead of wrinkle treatment methods, which are “invasive” but have a potentially more rapid effect.  We wanted to find out if controlled stimulation of facial muscles with this particular current could give results even after just a 3-week course of treatment, so therefore investigated the effects of the treatment using highly sophisticated quantitative assessment methods* musculocutaneous *ultrasonography and computerized image analysis.

                              SUBJECTS
14 female subjects aged between 38 and 52 years (average age 39.5), all with sedentary jobs and regular habits were chosen for the tests.  Their height and weight was no more than 20% over “ideal weight” for their age, calculated with current methods.
Among the patients, only one had a pathological medical history worth note, having had an episode of poliomyelitis at pre-scholastic age, but without any evident commemorative signs.  One of the patients had a partial removable denture.  All patientshad normal occlusion of the teeth.

                                  CONDITIONS
3 times a week for three weeks (a total of 9 sessions per person), their facial muscles (orbicularis oculi, orbicularis oris, and major zygomatic) were stimulated so as to obtain visible contraction. In the same sessions, contraction of the following muscles were caused:
-right orbicularis oris and zygomatic for 5 minutes.
-left orbicularis oris and zygomatic for 5 minutes.
-right orbicularis oculis for 5 minutes.
-left orbicularis oculis for 5 minutes.

To ensure that the muscles were always stimulated in the same position, the unit was applied to the muscles under medical control.  The intensity of the contraction on the other hand was decided by each patient, who turned the control knob until she felt the stimulus and caused contraction, which the doctor could see.
At the end of the series of sessions, an anonymous questionnaire was submitted.
Immediately before the start of the tests, an ultrasound test of their facial muscles was done and photographs taken.  Immediately after the tests, another muscular ultrasound test was done and more photographs taken to enable comparison.

                                                  Ultrasonographic documentation
The study was carried out with real-time equipment, using a 7.5 MHz linear probe, scanning on the *sagittal planes at the level of the zygomatic muscle, using the distal part of the *zygomatic bone as a reference point.
The exam was carried out immediately before and after the treatment, taking into consideration both the morphology and the thickness of the layer of subcuntaneous adipose tissue and muscle and measuring the *anteroposterior diameter of both at numerous well-defined points.
The ultrasonographic anatomy of the subcutaneous adipose tissue consists of parts with low/medium visibility divided by visible parts making up the fibrous connective structures and the adipose tissue itself, which in normal patients are parallel and regular.

The average anteroposterior diameter of subcutaneous tissue in a normal female patient is 1.8mm. In an ultrasound test, the muscular tissue of a normal patient shows a uniform distribution of echos of average intensity, with visible parallel striations, which make up the muscles’ tertiary fasciae: the normal average thickness of the zygomatic muscle is 3.5mm.

                                                      Photographic documentation
Tests of the effectiveness of a treatment which aims at giving vigor and tension to the face’s skin by stimulating facial muscles must also include in its analysis images of the faces before and after treatment.  Although these differences may be appreciated at a subjective level by merely comparing photographs taken at various stages during treatment, to ensure scientific precision, it is essential to ascertain the morphological differences in the body’s surface objectively.  Objective evaluation has always involved numerous difficulties of a technical nature which have been overcome only recently with the use of computers.  Computers in fact enable to transform a photographic image, fundamentally made up of a series of colored dots, into a set of vectors which, when suitably filtered and processed, can be used for calculation and comparison.  For images to be processed by the computer, it is also indispensable that the photographs are taken in such a way as to avoid even small artificial differences between those taken before and after the therapy, optimizing the use of camera and flashes as well as the position of the face and any corrective cosmetics used by the patient.
To ensure this, a special “photographic studio” was set up, with a tripod firmly mounted on a table together with a face-holder based on those used with Micro Nikon 105mm lenses, with a distance of 1 meter between film surface and focus point (patients’ pupils).  Lighting was supplied by two flashes with different power set in front of the patients and 30cm. from the camera.  The patients’ position was checked each time by means of a special “chequered” focusing screen, in which the pupils were always positioned at exactly the same point.  The 35mm. Slides obtained were then fed into a Macintosh VX computer by means of a digitizer board and a Tamron slide scanner.  After the digitization of the images using special Adobe software, the next step was to check and correct any possible artifacts, both foreseeable ones caused by the methods used (basically very small differences in shots and lighting) and those caused by patients’ behavior.  The images were then recomposed and “before” compared with “after”.

The day before treatment began, photographs were taken in three fundamental positions: full frontal, at an angle of 45* and profile.  Each patient filled out a personal form with her medical history and was allocated a number to ensure the anonymity of the images’ analysis.  The day after treatment finished, the same photographs were taken with the equipment (which had not been touched in the meantime).  Regarding cosmetic make-up, it was preferred to photograph the patients with their own day-to-day make-up, ensuring that it was the same at the two photographic sessions.

                                                           Results
All 14 women finished the experiment, which lasted 3 weeks.  The electric stimulation of their facial muscles was judged (Tab. No. 1) “painless by all patients and even pleasant by more than 2/3 of them.  According to half of the patients, both facial muscle tone and appearance had already improved at the end of this short treatment.  Lastly, all insisted on being allowed to continue stimulation at home with TUA after the experiment.  No undesirable effects were noted on their facial skin during or at the end of the treatment.

As far as subcutaneous adipose tissue was concerned, the ultrasound test carried out before the treatment showed an uneven distribution of visibility, with irregular fibrous connective parts, in the context of which clearly visible spaces due to lipodystrophic tissue were noted.  The average thickness of the subcutaneous tissue was 2mm. (range: 1.7-2.4mm).  The muscular tissue had a uniform average visibility with parallel, quite uniform distribution of the tertiary fasciae.  The anteroposterior layer of muscular tissue was on average 3mm. (range: 2.5-3.5).

In 80% of the patients, the ultrasound test done after treatment showed a reduction in the thickness of subcutaneous adipose tissue, quantized as 0.2mm.  In particular, a more homogeneous state of the fibrous connective sections with partial or total loss of the areas of liposclerosis.  The muscular tissue on the other hand had a modest increase of visibility, due to improved muscular tone, with an average increase in thickness of 0.3mm.  The greatest difference obtained during the tests was with patient No. 8, with whom we had the following results:  value of the adipose layer before therapy was 4.4mm. and 1.6mm.after therapy:  the value of the muscular layer before therapy 2.8mm. and after therapy 3.2mm.

Preliminary photographic analysis of the 14 groups of tracings of the patients carried out in the 3 positions enabled to note an increase in skin tension and in some cases a measurable increase in the dimension of some muscles.
By overlaying Bezier curves on the profiles of the various muscles (a function which enables to calculate the variable angle curves), it can already be concluded that for six patients there was an increase in the dimension of the muscles of the masseteric region, noticeable with the muscles contracted in four of them.
For the other regions of the face under treatment, although comparison and superimposing the tracings would suggest a greater skin tension, no “quantization” of the changes has been reached.

Study being carried out on the tracings will enable to accurately define the amount of change, which took place, allowing a statistic analysis of the results.

                                                         Conclusions
Stimulation of the muscles of the face with Vupiesse Italia’s “TUA VISO” enabled to obtain in 14 female subjects an appreciable increase in muscular tone, after a period of controlled treatment of just three weeks.  The stimulation of the muscles of the face was referred by 100% of the subjects as being painless and even pleasant by more than 2/3 of them.  The women who participated in the experiment had high hopes and after just three weeks’ treatment, half of them reported that their faces muscular tone and appearance had improved.  The ultrasound method proved very useful in showing the pathological aspects of the layer of subcutaneous tissue and muscles before the treatment and their partial regression at the end of the cure.  The reshaping of the face was adequately studied by means advanced methods for the acquisition, processing and analysis of the photographic images.
 
This test enabled to state that the treatment of facial muscles with electric stimulation is safe and painless and even after just three weeks is able to improve the tone and appearance of the muscular and subcutaneous tissue.  It can be expected that longer (or even continual) treatment, such as that which can be carried out at home with the tested unit, would have greater, longer lasting results, using effective painless stimulation to fight the regressive phenomena of the subcutaneous-muscular complex which in conclusion are to blame for the anti-aesthetic “wrinkles”.

TUA VISO
QUESTIONNAIRE RESULTS

1-Found the stimulation:
a) Painful                                  0/14  (0%)
b) Painless                                14/14(100%)
2- The stimulation is:
a) Pleasant                                10/14 (71.4%)
b) Unpleasant                           3/14 (21.4%)
     Rather annoying                           l/14 (7.2%)
     (Not on the list)
3- The tone and appearance of the facial muscles are:
a) Improved                             7/14 (50%)
b) Unchanged                           7/14 (50%)
c) Worse                                  0/14 (0%)

Glossary
Musculocutaneous- Pertaining both to muscles and skin; as, the musculocutaneous nerve

Ultrasonography- A laboratory examination, which uses ultrasonic energy to control and graphically reproduce the volume of muscles or other tissues or cavities .

Sagittal - Of or relating to the suture uniting the two parietal bones of the skull.
Orbicularis oculi - eye muscle

Lipodystrophic- A disorder of adipose (fatty) tissue characterized by a selective loss of body fat.

Anteroposterior -From front to back

Zygomatic- Of, relating to, or located in the area of the zygoma: a zygomatic muscle.

Quantized- To limit the possible values of (a magnitude or quantity) to a discrete set of values by quantum mechanical rules. Echos- A repetition or an imitation

Masseteric- A thick muscle in the cheek that closes the jaws during chewing

Bezier- Curves and surfaces are defined by a set of "control points"
which can be moved interactively making Bezier curves and
surfaces convenient for interactive graphic design.



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