PSTIM

Frequently Asked Question About PSTIMs

What is PSTIM and how does it work?

PSTIM is a microchip-controlled pulsed neurotransmitter. It provides a continuous flow of intermittent, low frequency electrical pulses to specific peripheral nerves with end locations in the ear relieving many types of acute and chronic pain.

Application can be accomplished in a productive time frame. Percutaneously placed, the device continues to provide peripheral nerve stimulation for four consecutive days.

Because the device is light weight (7g) and size, patients can continue to enjoy normal daily activities during treatment. Depending on the level and length of a patient’s pain, PSTIM may be placed up to nine sessions a week apart, with increasing pain relief throughout the series of treatments. PSTIM may also be used for post operative pain management and other symptom specific treatments.

Who created PSTIM?

Dr. J. Constantine Szeles created PSTIM, originally called PSTIM, on the foundation of electro-auricular peripheral nerve therapy. In 1994, Dr. Szeles was granted patents in Austria and the United States for his PSTIM therapy. The PSTIM technology has been used to treat more than 20,000 patients with acute and chronic pain conditions in and outside the United States.

The results of continuing clinical studies demonstrate that specific stimulation of peripheral nerve endings located in the auricular region not only relieve pain, but also seem to regulate secondary effects common in pain patients such as anxiety, depression and insomnia.

Who Benefits from PSTIM?

PSTIM was created for patients who suffer from chronic pain including upper and lower back pain, fibromyalgia, arthritis, sciatica, cervical/neck pain, joint pain, cancer pain, and migraines. Patients with post-operative pain have also benefited from reduced pain and less narcotic consumption and side effects.

How will my pain patients benefit from PSTIM?

PSTIM is:

• Percutaneously placed on an outpatient basis with little or no complication
• Self contained, miniaturized, battery-powered, providing continuous stimulation
• Consistent electrical current, via standardized microchip control
• Small, light and comfortable enough to wear behind the ear for 4 days
• Mobile, allowing patients to continue with most activity without restriction
• Light weight (7g), allowing a patient to enjoy normal daily activities

What tools will I use to apply the PSTIM device to my patients?

You will be trained to use a Multi-Point Stylus to apply PSTIM. The stylus is used to locate the proper peripheral nerves via visual and audible indication signals.

Who can place the PSTIM device?

A Licensed M.D. or D.O. who is certified to place the PSTIM.

What is the typical treatment regimen?

In clinical trials, a typical treatment regimen is one to nine applications for the relief and sometimes, cessation of acute and chronic pain.

Patients with acute pain tend to have shorter treatment regimens than those with long term, chronic pain. Each treatment regimen is tailored to a patient’s needs, with one weekly application during the initial phase. Once the patient’s pain level is minimized, the additional applied treatments increase the patient’s natural pain threshold. With consistent PSTIM application, patients can accumulate long-term pain relief that will be felt long after the treatment cycle is completed. If pain does return, physicians will typically utilize a shortened treatment protocol to maintain pain relief.

With repeated placement of the 3 electrodes at the same site lead to loss of a therapeutic response?

No. The PSTIM Device operates on a very low frequency low voltage and the therapeutic response does not appear to wane with repeated applications.

Does the device interfere with hearing when used chronically?

There are no indications of hearing loss in any of the literature or 20,000 plus clinical applications performed to date.

Are there any contraindications for use of the device? (Diabetes, hypertension, age, pregnancy, skin disease etc?)

There are very few contraindications for the PSTIM.

Absolute Contraindications are:
Anti-coagulant therapy, recent transplant, site infections, and history of aneurisms.

Relative Contraindications are:
Pregnancy, pacemakers, contact dermatitis to adhesives (latex allergy), or the occurrence of an MI within the last 6 months.

All indications are up to the discretion of the physician in charge and it is the responsibility of the supervising physician to review the patient’s condition before treatment.

Are there any age restrictions to the use of PSTIM?

It is recommended that PSTIM only be placed on patients 15 years or older due to level of activity.

Are there any negative effects on the ear from chronic use of the device?

Most patients may receive all treatments on the same ear. If the patient experiences any tenderness after a few treatments on one ear, it may be advisable to change ears for the next few treatments.

The device is "minimally invasive" is there any risk of infection or bleeding at the applied site?

As with any minimally invasive procedure there is a minor risk of infection but the risk is mitigated by proper sanitizing techniques. Bleeding has rarely been reported.

Can the device be used in persons taking other pain medications? (E.g. Vicodin, Oxycontin, Motrin, Fentanyl) for pain?

Absolutely. In fact, the treatment is designed to work with patients who are currently on pain medications. We ask patients who are on meds to continue normally so that we may evaluate the effectiveness of PSTIM above and beyond their current treatment regimen. After a few treatments and stabilization of a lowered pain level, PSTIM providers may work with the patient’s primary physician, if different, to reduce and in some cases discontinue medications.

If the device is discontinued following acute or chronic use how long is the "therapeutic" effect expected to last?

Given a normal course of treatment, patients have been recorded as receiving benefit for period of months, sometimes longer. When or if pain returns, the subsequent treatment regimen is usually an abbreviated one.

Does exposure to radiation, low or high frequency electrical sources (i.e. microwave, airport security screening, implanted pacemaker, etc.) affect function of the device?

No.

Is there a safety issue if the device gets wet??

There are absolutely no safety issues with getting the device wet. The device may simply cease to work if it is exposed to water. Care should be taken to avoid submission or direct contact with water during the treatment regimen.