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Electrical stimulation

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P-STIM
Application
Literature
Product History
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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.

image multipoint pstim   image pstim ear   image pstim brain





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.




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.




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.

product image pstim product image pstim set product image multipoint





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.


Master distributors for the US market certified by Biegler:

IHS Innovative Health Solution
823 South Adams St, Suite B
PO Box 397
Versailles, IN 47042

Phone: 812-609-4183
email: info@pstimus.com
www.pstimus.com

Eagle Advancement Institute
7091 Orchard Lake Rd
West Bloomfield, MI 48322

Phone: 248-562-7284
email: jcarpenter@eagleadvancementinstitute.com
www.eagleadvancementinstitute.com


Master distributor for the Australian market certified by Biegler:

Mr. Shahid Ghauri
PO Box 925
South Perth
Western Australia 6951

Phone: +61 (0) 41 919 0901
email: shahid@pstimaustralia.com.au


Distributor for Austria certified by Biegler:

Ducest Medical GmbH
Waldstrasse 61
7222 Rohrbach bei Mattersburg
Austria

Phone: +43 3262 664550
email: office@ducest.com
www.ducest.com






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


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For further information see the product brochure

> pstim_folder_en.pdf

P-STIM in Medica Publication

> medica_innovation2002_en.pdf

Supplement for usermanual EMC tables

English
> pstim_emc_en.pdf
> multipoint_emc_en.pdf

Notice on counterfeit devices

> Notice on counterfeit devices


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