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P-STIM
Application
Literature
Product History
Distribution
Contact
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The P-STIM is a miniaturized device designed to administer
auriculo point stimulation treatment over several days. The advantage of using the ear
for such treatment is that it offers numerous points for stimulation within a
small area. Stimulation is performed by electrical pulses emitted through selectively
positioned needles.
Point stimulation by the P-STIM is mainly used to treat pain. Use of the
device is recommended for pre-operative, intra-operative and post-operative pain therapy
as well as for the treatment of chronic pain. At the same time there would appear to be
possibilities of using this concept in the future in the treatment of addiction and
allergy and in special fields of anaesthesia.
P-STIM allows to perform continuous point stimulation over a period of several days
and offers the patient a high degree of comfort and mobility. An advantage over drug
therapy is that the
patient no longer suffers any of the possible side-effects of pain-killers such as
impaired reactions. In other words, the patient can continue to lead his life as usual,
without loss of quality.
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Application
The doctor uses the pointer to locate the first of the three stimulation points. When the
pointer locates one of the points, the electrical resistance changes, causing the
illuminated ring to light up and an acoustic alarm to sound. The doctor marks this point
with a positioning plaster previously picked up with the pointer. Then he repeats the
procedure until all three points are located and marked. Only now does the doctor pick up
the needles and place them in position with the positioner.
The P-STIM is activated by removing the self-adhesive foils from the batteries and
snapping the cap onto the device.
The device itself is fixed underneath the ear with the integrated self-adhesive
electrode. The wires from the device are connected to the needles simply by snapping
conductive plastic rings over the needle heads. This is the beginning of the treatment.
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Literature
Sator-Katzenschlager SM, Scharbert G, Kozek-Langenecker SA, Szeles JC,
Finster G, Schiesser AW, Heinze G, Kress HG. "The short- and long-term benefit in chronic low back pain through
adjuvant electrical versus manual auricular acupuncture.",
Anesth Analg. 2004 May;98(5):1359-64
Department of Anesthesiology and Intensive Care Medicine (B), Outpatient Pain
Center, University of Vienna, Vienna, Austria.
Abstract:
Acupuncture is an established adjuvant analgesic modality for the treatment of
chronic pain. Electrical stimulation of acupuncture points is considered to
increase acupuncture analgesia. In this prospective, randomized, double-blind,
controlled study we tested the hypothesis that auricular electroacupuncture (EA)
relieves pain more effectively than conventional manual auricular acupuncture
(CO) in chronic low back pain patients with insufficient pain relief (visual
analogue scale [VAS] > or = 5) treated with standardized analgesic therapy.
Disposable acupuncture needles were inserted in the auricular acupuncture points
29, 40, and 55 of the dominant side and connected to a newly developed
battery-powered miniaturized stimulator worn behind the ear. Patients were
randomized into group EA (n = 31) with continuous low-frequency auricular EA (1
Hz biphasic constant current of 2 mA) and group CO (n = 30) without electrical
stimulation (sham-electroacupuncture). Treatment was performed once weekly for 6
wk, and in each group needles were withdrawn 48 h after insertion. During the
study period and a 3-mo follow-up, patients were asked to complete the McGill
questionnaire. Psychological well being, activity level, quality of sleep, and
pain intensity were assessed by means of VAS; moreover, analgesic drug
consumption was documented. Pain relief was significantly better in group EA
during the study and the follow-up period as compared with group CO. Similarly,
psychological well-being, activity, and sleep were significantly improved in
group EA versus group CO, the consumption of analgesic rescue medication was
less, and more patients returned to full-time employment. Neuropathic pain in
particular improved in patients treated with EA. There were no adverse side
effects. These results are the first to demonstrate that continuous EA
stimulation of auricular acupuncture points improves the treatment of chronic
low back pain in an outpatient population.
IMPLICATIONS: Continuous electrical
stimulation of auricular acupuncture points using the new point stimulation
device P-stim significantly decreases pain intensity and improves psychological
well-being, activity, and sleep in chronic low back pain patients.
Publication Types: Clinical Trial, Randomized Controlled Trial
Further Literature:
E.A.Ghoname, W.F.Craig, P.F.White, H.E.Ahmed, M.A.Hamza, N.M.Gajraj, A.S. Vakharia,
C.E.Noe: "The Effect of Stimulus Frequency on the Analgesic Response to Percutaneous
Electrical Nerve Stimulation in Patients with Chronic Low Back Pain",
Anaest.Analg.1999/88.841-6
B.Wang, J.Tang, P.F.White, R.Naruse, A.Sloninsky, R.Kariger, J.Gold, R.H. Wender:
"Effect of the Intensity of Transcutaneous Acupoint Electrical Stimulation on the
Postoperative Analgesic Requirement", Anaest.Analg.1999;88:841-6
M.R.Hoda, W.Lechner, K. Grimm, F.X.Stöger, J.C.Széles: "Pre- and
Postoperative Pain Management in a Surgery Unit: Preliminary Results of Using
Miniaturized Ear Electroacupuncture and Perspectives for Future Clinical
Investigations" Abstract, Acta Chirurgia Austriaca, Vol. 32, Supplement 162,
2000
Verification of Efficiency
The most important and the most interesting experiments providing scientific support
for acupunctural analgesia were studies (e.g. Mayer et. al) conducted on humans and
animals using endorphin antagonists (e.g. Naloxon, Naltrexone).
As new results indicate, the strong analgesic effect of electro acupuncture in the
low-frequency range is due to methionin/encephalin release and in the high-frequency
range due to A-dinorphin. At the same time, the higher concentration of the body's
own circulating morphins improves the sense of well-being. A treatment unit based on
these findings is now available. It is notable among other things for being user-friendly,
quick to apply and comfortable to wear.
P-Stim auriculo is ideal for point stimulation on the ear. We recommend stimulating the
points according to Somatotopie Nogier. In cases of chronic low-back pain the desired
effects are achieved by microstimulation, having selected two general pain points and
one local stimulation point on the ear. In cases of prolonged chronic pain we recommend
an overall therapy period of 6 weeks. Control tests should be carried out within 6 months
to check the success of the therapy using VAS (visual analog pain scale).
For chronic and acute pain, and for chronic pain patients, P-Stim auriculo should always
be used for 4 days of therapy.
Conclusions
Amongst other things, the form of therapy presented by this concept opens up new
possibilities for the treatment of pain patients.
The application spectrum for this form of treatment ranges from surgical patients
(wound pain) to patients suffering from chronic pain.
The advantage of using this device, even for chronic pain, lies in the fact that
it has no organ-damaging side effects. A long-lasting course of medication can often
cause damage to internal organs, such as the kidneys, resulting in kidney transplants
or dialysis patients at the very least. This leads to extremely high costs for the
health service.
To avoid post-operative complications such as pneumonia, it is important to mobilize
patients as soon as possible after an operation. The period of hospitalization and the
resulting costs can be reduced by rehabilitating the patient sooner. By using P-Stim,
the patient experiences improved sleep and so the nursing staff's work is made much
easier.
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Product History
Dr. Széles of the Clinical Department for Vascular Surgery at Vienna General
Hospital invented the P-STIM and was also responsible for its medical development. In
other words, the P-STIM is a product created by a medical practitioner for medical
practice. Dr. Széles and BIEGLER have worked together on developing the product
into functional prototypes.
Four hundred and fifty P-STIM devices of the first generation were in use as
part of a study that was conducted at Vienna General Hospital and at Tulln State Hospital.
Use of this first generation of devices has led to two important findings: First, it was
possible to demonstrate their effectiveness for the indications "pain" and "adipositas";
this was a major precondition for further investments. Second, it became clear that the
product did not yet meet the practical requirements of users and patients. For patients
it was important above all for the devices to be comfortable to wear. Users, on the other
hand, demanded a technical solution which would enable them to locate the stimulation
points exactly and apply the needles easily and safely.
A new concept for the P-STIM was developed from these demands. With an ergonomic and
space-saving design of the housing the P-STIM was miniaturized to such an extent that it
became possible to integrate the entire device in the earth electrode. Now the P-STIM can
now be stuck - easily and safely - below the ear using this electrode.
It is now also far easier to locate the exact stimulation points and place the
needles. With a purpose-developed pointer it is possible to locate an
stimulation point and to mark it simultaneously with an adhesive ring picked up in
advance. With a simple sliding movement the same pointer is then used to pick up and
insert the sterile stimulation needle in the previously marked position.
A user-friendly solution was also found for connecting the device to the needles:
Instead of fastening the elaborate plug-type connectors the user now only has to snap-fit
plastic rings over the needle heads.
Starting the device is also extremely easy: The user only has to remove the three
adhesive foils from the batteries and snap on the cover. The device is actuated
automatically, ruling out operating errors. Therapy is ended simply by removing the
stimulation needles and pulling off the adhesive electrode. Solid gel is used for the
electrode so that no gel remains on the skin when the electrode is pulled off.
The second-generation P-STIM is designed as a disposable device for reasons of hygiene
and application. The complete unit can be disposed off in accordance with the applicable
local regulations.
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Distribution
P-STIM is available via distribution partners. Please send us
an e-mail so that we can inform you about your nearest source of supply.
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Contact
Biegler GmbH, Allhangstrasse 18a, A-3001 Mauerbach, Austria
Tel. +43 1 979 21 05 Fax. +43 1 979 21 05 16
email: office@biegler.com
www.biegler.com
You are welcome to contact the following addresses in order to discuss experiences in
the use of P-STIM and its effectiveness:
Dr. Constantin Szeles
email: j.szeles.akh@aon.at
Phone: +43 676 614 2093
Dr. Szelés works in the Clinical Department for Vascular Surgery at Vienna General
Hospital. He invented the P-STIM and contributed to the product's development on the
medical side. Use of the first generation of devices has enabled Dr. Szelés to
accumulate considerable experience already. His findings were published in the above
mentioned studies.
Dr. Reinald Brezovsky
email: brezovsky@aon.at
Gesundheitszentrum Döbling
Döblinger Hauptstrasse 44
A-1190 Wien
Phone: +43 699 109 13 901
Dr. Brezovsky works at the Health Center Döbling (Vienna). As a specialist for
neurosurgery he was able to gather many years of clinical experience in pain therapy at
Vienna General Hospital, particularly in connection with spine ailments. At the Health
Center Dr. Brezovsky is now mainly involved in alternative forms of therapy, e.g.
auriculo acupuncture.
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