| Introduction | Patient Treatment Protocol | Safety Studies |
| Fact Sheet | Therapy | Clinical Studies |
The
Sonotron - A non-invasive therapy device utilizing low power modulated
radio-frequency (RF) and audio energy in the form of a visible and audible
corona discharge beam
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This
center believes in a coordinated multidisciplinary approach to treating
chronic pain, offering the best of traditional and holistic medicine in
a caring, supportive atmosphere. The center believes the patient should
participate in designing a treatment regimen that addresses their problem
in the best way possible.
Some of the types of pain treated at this center are: fibromyalgia, reflex sympathetic dystrophy, arthritis, diabetic neuropathy, headaches, cancer pain, chronic abdominal or plevic pain, post amputation pain, failed back surgery syndrome, low back pain, neck pain, facial pain, post herpetic neuralgia and TMJ pain.
The specialties that are covered by the staff are anesthesiology, neurology, psychiatry, psychology, dentistry, hypnotherapy, biofeedback, acupuncture, massage therapy, shiatso, jin shin dyutsu, Feldenkreis method, nutrition and stress management. This center also has its own operating room with C-arm digital fluoroscopy making it possible for placement of implantable epidural and spinal narcotic pumps and spinal cord stimulators without hospital stay.
Because of its central location in the state, the patients come from northern and southern New Jersey along with eastern Pennsylvania.
The Center opened its doors in April of '95 under the direction of Leslie M. Greenberg, MD, founder and director. Dr. Greenberg is board certified in otolaryngology, and anesthesia. Having been trained at Harvard Medical School and Brigham Women's Hospital in Boston, he is also an attending anesthesiologist at the Medical Center at Princeton.
The Sonotron is operated by the medical staff under AA Northvale Medical Associates and is supervised by Herb Etzold, a representative of Sonotron Medical Systems, Inc.
Some of the types of pain treated at this center are: fibromyalgia, reflex sympathetic dystrophy, arthritis, diabetic neuropathy, headaches, cancer pain, chronic abdominal or plevic pain, post amputation pain, failed back surgery syndrome, low back pain, neck pain, facial pain, post herpetic neuralgia and TMJ pain.
The specialties that are covered by the staff are anesthesiology, neurology, psychiatry, psychology, dentistry, hypnotherapy, biofeedback, acupuncture, massage therapy, shiatso, jin shin dyutsu, Feldenkreis method, nutrition and stress management. This center also has its own operating room with C-arm digital fluoroscopy making it possible for placement of implantable epidural and spinal narcotic pumps and spinal cord stimulators without hospital stay.
Because of its central location in the state, the patients come from northern and southern New Jersey along with eastern Pennsylvania.
The Center opened its doors in April of '95 under the direction of Leslie M. Greenberg, MD, founder and director. Dr. Greenberg is board certified in otolaryngology, and anesthesia. Having been trained at Harvard Medical School and Brigham Women's Hospital in Boston, he is also an attending anesthesiologist at the Medical Center at Princeton.
The Sonotron is operated by the medical staff under AA Northvale Medical Associates and is supervised by Herb Etzold, a representative of Sonotron Medical Systems, Inc.
All
patients who expressed localized joint pain were treated with the Sonotron.
This was done with the belief that if there was no relief at their first
treatment, another modality was selected.
No x-rays are taken on the premises.
This initial period use of the Sonotron was experimental to see how patients reacted to this type of therapy - and also what types of problems can best be treated with the Sonotron.
Before the use of the Sonotron all patients were evaluated by an attending physician using the center's pain scale form. They each were required to read and sign a patient consent form and the physician signed and filled out the attending physician statement.
The evaluation form was completed on all patients whether they had one treatment or multiple treatments
No x-rays are taken on the premises.
This initial period use of the Sonotron was experimental to see how patients reacted to this type of therapy - and also what types of problems can best be treated with the Sonotron.
Before the use of the Sonotron all patients were evaluated by an attending physician using the center's pain scale form. They each were required to read and sign a patient consent form and the physician signed and filled out the attending physician statement.
The evaluation form was completed on all patients whether they had one treatment or multiple treatments
All
patients understood that they were part of a United States Food and Drug
Administration study. In addition, confidentiality of patient information
and medical history was assured.
All 24 patients are listed with their results from the initial trial period of six months.
All 24 patients are listed with their results from the initial trial period of six months.
The
patients' range in age was 18 to 99 years with a median age of 72. The
mean was 6 years younger and the mode was 3 years older than the median
(Chart 1). In the population there were 7 males and 17 females (Chart
2).
Nine areas of the body were treated (Chart 3). The lower back (lumbar area) had the highest number of patients. Seven shoulders were treated for pain, six knees, four hips, four ankles and one each for hand, upper back, wrist and TMJ. Out of 24 patients nine had more than one joint treated.
Even though all the patients never completed 3 or 4 treatments, only 4 had no reduction in pain. Chart 4 illustrates the difference in patients' pain as recorded in the patient record.
Nine areas of the body were treated (Chart 3). The lower back (lumbar area) had the highest number of patients. Seven shoulders were treated for pain, six knees, four hips, four ankles and one each for hand, upper back, wrist and TMJ. Out of 24 patients nine had more than one joint treated.
Even though all the patients never completed 3 or 4 treatments, only 4 had no reduction in pain. Chart 4 illustrates the difference in patients' pain as recorded in the patient record.
The
Sonotron is a patented non-invasive medical electronic therapy device
used in the treatment of joint conditions such as osteoarthritis, tendinitis,
bursitis, TMJ and sports related joint injuries. Additional studies with
the Sonotron Device have shown positive results in treating Carpal Tunnel
and Tarsal Tunnel Syndromes. The Sonotron Device employs modulated low
radio frequency (RF) energy coupled with an audio wave to produce a corona
discharge output. The corona discharge is emitted through a hand held
applicator and is applied in a circular movement directly over the joint
or injured area in the form of treatment units (TU). The number of Treatment
Units administered may depend on the size of the joint and the degree
of inflammation. Protocols have been established and are listed in the
Operator Guidebook. The exact number of TUs should be determined by the
administering physician. A treatment unit (TU) is a microprocessor controlled
15 second output of the patented Corona Discharge.
| Power Requirements | 100,120,220,
240 VAC (+/- 10%), 60 or 50 Hz 5 amps maximum under load |
| Output Frequency | 430 kHz (+/- 3%) |
| Weight | 30 lbs. (13.6 kg) |
| Base Unit Dimensions | Height: Width: Depth: |
7
3/4 in. 21 in. 15 in. |
(19.7
cm) (53.3 cm) (38.1 cm) |
| Applicator Dimensions | Barrel
Length: Barrel Diam: Handle: |
11
in. 2 7/16 in. 4 1/2 in. |
(27.9
cm) (6.17 cm) (11.43 cm) |
The
Sonotron is a non-invasive device which uses a corona discharge to treat
painful joint conditions. It employs radio frequency energy of 430 kilohertz
(430,000 cycles per second, long wave) combined with a sound wave at 1
kilohertz (1,000 cycles per second, audible). The resulting energy of
this combined wave is emitted through a hand held applicator in the form
of a corona discharge. The output power of the Sonotron is 8 watts and
the patient is exposed to the corona output for short periods of 45 seconds
to 3 minutes depending on the size and density of the joint. After a series
of 3 to 5 treatments, patients have reported pain relief which has lasted
for comparatively long periods, typically averaging 4 to 6 months. There
have been no reported side effects or hazards.
Radio
Frequency or RF Diathermy has been used for decades for treating painful
joint conditions by developing deep heat within tissue. As its name implies,
RF Diathermy creates deep heat in the body by use of electromagnetic energy
which is passed from a transmitter electrode to a receiving electrode
with the painful body part carefully positioned between these electrodes.
RF Diathermy uses radio waves at 27.12 megahertz (27,120,000 cycles per
second) - a microwave frequency. In order to achieve therapeutic heat
levels it requires 300 to 600 watts of power with the patient exposed
for 15 to 45 minutes. The patient does feel pain relief due to the therapeutic
effects of the heat which is generated in the joint. Typically the pain
relief lasts for several hours and diminishes quickly as the joint is
used and the heat is dissipated. Due to the power used there is an electrical
burn hazard associated with RF Diathermy which can be caused by improper
positioning of the patient or movement while treating.
Ultrasound Diathermy ("UD") is also a deep heat modality. Through vibrations
developed by sound waves emitted by the UD device, heat is developed by
the frictional vibration effect of cellular tissue movement. The UD device
is administered to the patient by first applying gel to the area to be
treated and then pressing a sound transducer to the area. The sound waves
are passed into the body to cause vibration of the tissues to create heat.
In order to be effective, the patient must be exposed to the sound waves
for 15 to 60 minutes and the application must be performed by a trained
technician to insure that proper contact is achieved. Although UD does
create deep heat it is not as efficient in the depth to which the heat
can penetrate due to the resistive and dissipative effect of the volume
and density of tissue. The patient does feel pain relief due to the therapeutic
effect of the heat which is developed in the joint. Typically the relief
lasts for several hours and diminishes quickly as the joint is used and
the heat is dissipated.
Cold
Laser Therapy ("CLD") is actually a misnomer due to the fact that the
output of these devices is not actually cold but is at a much reduced
level than those lasers used for cutting or burning. CLD is used for treating
joint pain by exposing the area to be treated with high intensity laser
light which penetrates deeply within tissue to achieve therapeutic heat.
There has also been research and theories developed regarding the hypothesis
that CLD does not rely solely on the heat generated by the laser but also
has a cellular effect. However, no definitive results have been achieved
to substantiate this theory. Patients that respond to CLD therapy do experience
pain relief for short periods. Certain patients have experienced negative
effects such as burns to certain laser frequencies.
| Modality | Power | Time Applied | Duration
of Relief |
Hazards |
| 8 watts | .75 to 3 minutes | months | none | |
| RF Diathermy | 300
to 600 watts |
15 to 45 minutes | hours | electrical burns |
| Ultrasound Diath. | 100
to 500 watts |
15 to 60 minutes | hours | none |
| Cold Laser | NA | 1 to 5 minutes | days | tissue burns |
The
Sonotron is a non-invasive device that employs modulated radio-frequency
(RF) energy in the form of a visible and audible corona discharge beam
emanating from a discharge electrode. The device is operated from 100,110,
220 or 240 VAC at 50 or 60 Hz power. The source of energy is an RF generator
set at 8 watts with a carrier frequency approximately 430,000 Hz. It utilizes
electromagnetic energy modulated at a lower frequency in the audio range
of 1,000 Hz. The discharge electrode is recessed within a plastic, heat
resistant polycarbonate housing (the Applicator) to assure that the electrode
remains at a constant preset distant from the skin. It is to be employed
as a therapeutic device that utilizes radio-frequency energy transmitted
through the air directly to the skin for treating joint conditions and
the newest findings show positive results in the treatment of Carpal Tunnel
and Tarsal Tunnel Syndromes.
Tests have been conducted by the Biomedical Engineering Staff of the Instrumentation
Systems Center in the College of Engineering of the University of Wisconsin
at Madison, to quantify and classify the output signals of the Sonotron
Device.
Output signals were found to resemble the frequency spectra of electrosurgical units, but with approximately 1/60th the current and power. The amount of power dissipated within the tissue was smaller, similar in magnitude to the power of a pocket calculator. Scientific literature indicates that this level is at or below the threshold of perception and small enough to preclude a burn hazard even in the event of an inadvertent ground contact.
Based on these data, it was determined that the Sonotron should be regarded as a non-significant risk device. This conclusion is based upon: a.) comparison of the device to other electro-medical devices presently in use with similar frequency content, and b.) literature reports on the effects of high frequency currents on human tissue.
Output signals were found to resemble the frequency spectra of electrosurgical units, but with approximately 1/60th the current and power. The amount of power dissipated within the tissue was smaller, similar in magnitude to the power of a pocket calculator. Scientific literature indicates that this level is at or below the threshold of perception and small enough to preclude a burn hazard even in the event of an inadvertent ground contact.
Based on these data, it was determined that the Sonotron should be regarded as a non-significant risk device. This conclusion is based upon: a.) comparison of the device to other electro-medical devices presently in use with similar frequency content, and b.) literature reports on the effects of high frequency currents on human tissue.
Two separate double blind clinical studies were performed at the University
of Wisconsin. The first study was an evaluation of Sonotron therapy in
the treatment of experimentally induced arthritis in the horse. This was
performed at the University of Wisconsin School of Veterinary Medicine
in Madison, Wisconsin. A group of thirty-five experimental ponies were
used in the first study. These adult ponies were in good physical condition
and without any observable lameness. The left and right middle carpal
joints were evaluated by x-ray and synovial fluid analysis to verify that
there was no evidence of arthritis within these joints prior to the study.
The ponies were then divided into two groups. One group served as the
control group and the other served as principals and were treated with
varying levels of Sonotron therapy.
A model of degenerative joint disease was created by injecting 10 mg. Of Amphotericin B in the left middle carpal joint. This has been shown to produce a predictable synovitis in ponies analogous to the synovitis seen in osteoarthritis.
After lameness was induced in all ponies with the injection of Amphotericin B into the left midcarpal joint, serial x-rays, joint swelling, range of motion and gait analysis were evaluated by a qualified expert in a double blind fashion on a weekly to bi-weekly basis until the conclusion of the clinical study.
At the end of the study, pathological specimens of the middle carpal joints were collected for gross and microscopic evaluation. The degree of degenerative and inflammatory changes was assessed by a board certified pathologist who had no knowledge of the treatment groups. The conclusion of the study indicated that Sonotron therapy had a significant effect in reducing the level of lameness in ponies with experimentally induced arthritis. Additionally, there was a significant reduction in the severity of gross pathological lesions, as well as joint swelling. Also noted was a marked increase in joint range motion, and improved gait, as recorded on video tape.
No harmful effects to the skin and no indication of pain were associated with the study. The study did not detect any harmful or negative effects from the use of Sonotron therapy during the entire period of study.
The second study was monitored by the University of Wisconsin-Madison Instrumentation Systems Center and was conducted at 5 geographically dispersed locations in the United States. This consisted of a multicenter short term single administration double blind randomized placebo control study of the efficacy and safety of Sonotron in the treatment of pain in human subjects with osteoarthritis of the knee. The evaluation protocol included an overall assessment of pain by the patient at rest, on a passive motion of the affected joint, and on weight bearing. Tenderness in the involved joint was assessed on a scale of zero to three. Other parameters included improvement of range of motion during treatment, improvement in fifty foot walking time, as well as global evaluation of patient response by patient and investigator.
The study was conducted at five regional centers on a population of ninety-eight human subjects. Data was analyzed by Chi-Squared analysis on eleven non-parametric measures to compare the relative responses of the randomly assigned control and treated sub-population. Two data sets showed a high probability (.001) that the subject's assessment of pain one week after administration was reduced in the treated, relative to the untreated control sub-population. These measures were knee joint pain on passive motion and knee joint pain at rest.
Other data indicated a trend of improvement one week after a single administration in the treated group as compared to the untreated group. These measures were global evaluations by the investigator and knee joint pain on weight bearing.
None of the ninety-eight subjects in the study reported adverse reactions to administration of Sonotron therapy which the investigators deemed significant or long lasting.
Additional studies have been conducted with the Sonotron Device. The newest studies completed showed positive results in the treatment of Carpal and Tarsal Tunnel Syndromes. If you are interested in learning more about the positive effects of Sonotron therapy please contact Michael Clark, International Marketing Representative.
A model of degenerative joint disease was created by injecting 10 mg. Of Amphotericin B in the left middle carpal joint. This has been shown to produce a predictable synovitis in ponies analogous to the synovitis seen in osteoarthritis.
After lameness was induced in all ponies with the injection of Amphotericin B into the left midcarpal joint, serial x-rays, joint swelling, range of motion and gait analysis were evaluated by a qualified expert in a double blind fashion on a weekly to bi-weekly basis until the conclusion of the clinical study.
At the end of the study, pathological specimens of the middle carpal joints were collected for gross and microscopic evaluation. The degree of degenerative and inflammatory changes was assessed by a board certified pathologist who had no knowledge of the treatment groups. The conclusion of the study indicated that Sonotron therapy had a significant effect in reducing the level of lameness in ponies with experimentally induced arthritis. Additionally, there was a significant reduction in the severity of gross pathological lesions, as well as joint swelling. Also noted was a marked increase in joint range motion, and improved gait, as recorded on video tape.
No harmful effects to the skin and no indication of pain were associated with the study. The study did not detect any harmful or negative effects from the use of Sonotron therapy during the entire period of study.
The second study was monitored by the University of Wisconsin-Madison Instrumentation Systems Center and was conducted at 5 geographically dispersed locations in the United States. This consisted of a multicenter short term single administration double blind randomized placebo control study of the efficacy and safety of Sonotron in the treatment of pain in human subjects with osteoarthritis of the knee. The evaluation protocol included an overall assessment of pain by the patient at rest, on a passive motion of the affected joint, and on weight bearing. Tenderness in the involved joint was assessed on a scale of zero to three. Other parameters included improvement of range of motion during treatment, improvement in fifty foot walking time, as well as global evaluation of patient response by patient and investigator.
The study was conducted at five regional centers on a population of ninety-eight human subjects. Data was analyzed by Chi-Squared analysis on eleven non-parametric measures to compare the relative responses of the randomly assigned control and treated sub-population. Two data sets showed a high probability (.001) that the subject's assessment of pain one week after administration was reduced in the treated, relative to the untreated control sub-population. These measures were knee joint pain on passive motion and knee joint pain at rest.
Other data indicated a trend of improvement one week after a single administration in the treated group as compared to the untreated group. These measures were global evaluations by the investigator and knee joint pain on weight bearing.
None of the ninety-eight subjects in the study reported adverse reactions to administration of Sonotron therapy which the investigators deemed significant or long lasting.
Additional studies have been conducted with the Sonotron Device. The newest studies completed showed positive results in the treatment of Carpal and Tarsal Tunnel Syndromes. If you are interested in learning more about the positive effects of Sonotron therapy please contact Michael Clark, International Marketing Representative.
