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    ANSiscope HRV Monitor Questions

 

    Pain Questions

    P-STIM Questions

    Auricular Acupuncture Questions

    Managing the Patient through P-STIM Treatment

ANSiscope HRV Monitor Specific Questions 

How is the ANSiscope HRV measurement administered and is it safe?

Electrodes are attached to the patient’s inner wrists and ankles and the HRVtest is taken. The procedure is non-invasive and takes approximately 15 minutes.

What is HRV testing?

It has been known for over 100 years that the electrocardiogram (EKG) signal contains information about the two components of the ANS – sympathetic and parasympathetic.  This information is contained within the R-R intervals (the time between heart beats) of the EKG

How is the DyAnsys ANSiscope HRV monitor different from other methods?

DyAnsys developed a proprietary technology to monitor the ANS from the R-R interval of the EKG signal.  The algorithm used has proved to be highly accurate and reproducible compared to other methods that use spectral analysis; this is based on independent, fundamental studies performed by Prof. Schondorf (McGill Univ. Montreal, Canada), a renowned expert in ANS function and clinical studies conducted on over 100,000 patients with diabetic autonomic neuropathy in India.

Lafitte M.J., Sauvageot O.R., Fevre-Genoulaz M., Zimmermann, M., Towards assessing the sympathovagal balance. Medical, Biological, Engineering & Computing 44 (2006), p.675-682.

500 heart beats for assessing diabetic autonomic neuropathy

Melvyn Lafitte et al. International Journal of Diabetes in Developing Countries 2005, 25:113-117

How does the ANSiscope calculation compare to previously known HRV measurements?

(1) Click here for a simple answer

(2) Click here for a detailed answer

What kinds of tests are used to treat chronic painand autonomic neuropathy with the ANSiscope HRV Monitor?

There are two parameters that are used to monitor and treat autonomic nervous system issues, Autonomic Dysfunction and Sympathovagal Balance. The Autonomic Dysfunction measurement is used by itself to detect and monitor the severity of diabetic autonomic neuropathy. Both measurements are used in the case of chronic pain.

What is the Autonomic Dysfunction measurement? 

The Autonomic Dysfunction measurement provides an overview of ANS behavior.  Patients in chronic pain may have a higher Autonomic Dysfunction value than healthy individuals.  As treatment progresses, their Autonomic Dysfunction values should improve.   A baseline is taken during the first patient visit for P-STIM treatment; a final progress test is taken during the last patient visit.  Ideally, additional progress tests should be taken on every fourth P-STIM treatment visit.

The situation with diabetic autonomic neuropathy is different. The American Diabetes Association recommends in its standards of care that testing for autonomic neuropathy be done as soon as diabetes is detected and repeated annually if negative. If positive, testing should be done along with treatment at quarterly intervals.

What is the Sympathovagal Balance trajectory?

This parameter reflects the instantaneous balance between the two components of the ANS (i.e. the sympathetic and the parasympathetic) at that point in time (the display will change with every heartbeat). In the case of chronic pain, it is used to monitor the progress of P-STIM treatment.  In addition, the plot of the sympathetic response is also used. During P-STIM placement, the sympathetic line (which is the beat by beat response of the sympathetic system) may spike, indicating needle insertion.  The sympathetic line may drop when the pain, due to needle insertion, subsides.   If the sympathetic line does not drop after needle insertion, then this is not a good location and should be removed and reapplied.

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Pain specific questions

What is P-STIM?

Point-Stimulation Therapy (P-STIM) is a new and highly effective approach to non-narcotic pain management.  The P-STIM is a wearable device that is designed to administer continuous pulses of a low-level electrical current at the ear over several days. Electrical pulses, involving Cranial Electrotherapy Stimulation (CES), are emitted through three selectively positioned acupuncture needles.  The advantage of using the ear for such treatment is that it offers numerous points for stimulation for all areas of the bodywithin a small area.

What is CES?

The P-STIM is based on Cranial Electrotherapy Stimulation (CES), which has been well researched since the 1950s. CES, combined with auricular acupuncture, has proved to stimulate a number of neuro-chemical and physiological conditions that are known to relieve chronic pain and depression. The key to this relief is the stimulation and release of endorphins, the body’s natural opiates.  These opiates assist with the increase in blood flow to affected tissues, resulting in the reduction of pain symptoms.  In addition to release of endorphins, CES has proved to also promote sympathovagal balance of the autonomic nervous system (ANS), reduction in central sensitization, and increasing peripheral artery blood flow.

For what types of conditions is the P-STIM used?

The P-STIM has been effectively used to treat a number of chronic pain and emotional conditions.  These include, but are not limited to: fibromyalgia, lower back pain, cancer pain, cranial facial pain / TMJ depression, insomnia, migraines, neuropathic pain, sciatica, shingles, vascular insufficiency, wound care, and many more pain related aliments.  Ask your doctor if your condition is appropriate for this treatment.

What is ANSiscope HRV testing?

In addition to the P-STIM treatment, a Heart Rate Variability (HRV) test using the ANSiscopeâ HRV Monitor will be administered to quantitatively assess the patient’s level of autonomic dysfunction and autonomic nervous system (ANS) balance.  Patients with chronic pain will have their ANS balance skewed towards the sympathetic nervous system, which promotes body action.  As treatment with the P-STIM progresses, the patient’s level of ANS balance will improve by moving towards the parasympathetic nervous system, which promotes body relaxation. The HRV test will also be used to optimize placement of the P-STIM during each treatment.

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P-STIM Specific Questions

How is P-STIM Therapy administered?

Placement of the P-STIM takes approximately 10-15 minutes.  The P-STIM is worn for four-days-on and three-days-off. and is removed by the patient on the fourth day.  Electrical stimulation occurs during those four days in three-hour intervals. The patient may carefully shower during this time, taking care not to get the P-STIM wet. Patients are requested not to wash their hair until after the device is removed.  A new P-STIM is applied every week and does require an office visit for placement.

How many P-STIM treatments are required to show relief?

The average patient usually requires 10-12 weeks of treatment.  However, this will varydepending upon the patient’s type and level of pain; it can be as few as 4 treatments and as many as 20 treatments before significant reduction in pain is noted.  It is important for the patient to commit to a series of weekly treatments, otherwise the program will not show the full desired results.

Is P-STIM Therapy safe and are there any side effects?

P-STIM pain relief treatment is designed to be minimally invasive and has virtually no side effects.  Three very small needles, similar to acupuncture needles, are applied to the ear.  Patients experience little to if any pain when the needles are applied.  However, during the four days when the P-STIM is applied, some patients may experience dizziness and/or nausea; this is due to overstimulation of the nerves and is relieved by removing one or two of the auricular needles.  The patient is encouraged to seek guidance fromtheir clinicianshould this occur.

Who developed the P-STIM?

P-STIM was developed by Jozef C Szeles, MD of the University of Vienna in Austria.  A vascular surgeon by training, Dr. Szeles first developed the P-STIM to minimize his patients’ post-operative pain; he found he could reduce or eliminate the use of painkillers with P-STIM treatment.   Unlike other CES technologies which apply electrical current for only several hours, Dr. Szeles discovered that a “wearable” P-STIM, with continuous pulses of low level current applied over several days, is more effective at treatment.  For more information, you may refer to the two scientific articles:

1.Sator-Katzenschlager, SM, Szeles, JC et al.  Anesth Analg 2003;97: 1469-7, 3.

2.Sator-Katzenschlager, SM, et al. AnesthAnalg 2004;98:1359-64.

How long has the P-STIM been in use?

Since 2002, Dr. Szeles has administered over 16, 000 treatments.  Applications expanded beyond post-operative pain to also include many types of chronic pain, as well as depression and anxiety.

How does the P-STIM work?

The 3 mm long needles transmit electrical pulses to the free nerve ends in the dermus.  The skin then transmits the pulses along the nerve tracks to the central lobe of the brain.  From the brain, endorphins are released.  These endorphins are carried by blood throughout the body.  Circulation is stimulated and muscles are relaxed at the same time.

Are the P-STIM and HRV Testing FDA cleared / CE marked?

Both the P-STIM and ANSiscope HRV Device are FDA cleared for use in the United States and CE marked for use in Europe.  Contraindications against the use of the P-STIM are certain heart conditions, pacemakers, recent organ transplants, history of seizures, and use of anti-coagulants.

Does medical insurance cover ANSiscope HRV testing and P-STIM treatments?

For practitioners within the United States, most major insurance providers will reimburse for HRV testing and P-STIM treatments. Ask your local distributor to see Explanation of Benefit (EOB) examples as proof of reimbursement.

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Auricular Acupuncture Questions

What is auricular acupuncture?

First developed in France in the early 1950s by Dr. Paul Nogier, he observed that a specific point in the ear was related to a major organ.   He began mapping the system and recognized that the ear corresponds to an upside down fetus position.  Points on the lower half of the body are at the top of the ear and vice versa.  His research was later verified in China by acupuncture experts.  The advantage of using the ear for P-STIM treatment is that it offers numerous points for stimulation for all areas of the bodywithin a small area.

Do you need to be an acupuncture expert to apply the P-STIM?

While P-STIM needle placement is guided by auricular acupuncture practices, one need not be an expert in acupuncture to effectively administer treatment.  Several tools are provided to make the treatment process easy to learn and administer; in addition to hands-on-training and a training video, practitioners are provided with auricular acupuncture charts (muscular skeletan region, organs, and points specific to depression, appetite, anxiety, etc), the ANSiscope HRV Monitor to verify optimum placement, and a stylus to locate positions of least resistance.

How is the multi-point Stylus used in locating ideal acupuncture points?

Ideal needle locations are those areas that allow electrical stimulation to reach the free nerve ends located just beneath the skin.   Often times, due to inflammation, the electrical stimulation cannot reach the free nerve ends as easily and/or you are hitting a nerve.  The multi-point stylus will emit a high-pitched sound in those areas of least resistance (ideal placement) and a low-pitched sound in areas of high-resistance (not ideal for needle placement).

How is the ANSiscope HRV Monitor used to locate ideal needle locations?

During P-STIM placement, the sympathetic line may spike, indicating needle insertion.  The sympathetic line may drop when the pain, due to needle insertion, subsides.   If the sympathetic line does not drop after needle insertion, then this is not a good location and should be removed and reapplied.

Why are three acupuncture needles used in this procedure?

Two needles are used for general pain and the third needle is positioned for that patient’s specific type of pain – such as lower back pain.  In Chinese medicine, the two general pain needle locations are called Shen Men (located at the top of the ear to stimulate the vagus nerve) and Cushion (located near the lobe of the ear to treat general pain).

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Managing the Patient through P-STIM Treatment - Specific Questions

Are there any side effects to P-STIM Treatment?

Some patients may experience various symptoms associated with increased ANS activity, if they are receiving too much stimulation.  This can include: dizziness, nausea / vomiting, more pain than usual, increased heart rate and/or blood pressure, excessive perspiration.

How should we manage patients with side affects as a result of too much stimulation?

Side effects can occur within the first day or not until several days after the P-STIM placement.  To minimize over stimulation, have the patient remove one or two of the needles and cut the wire.  First, begin with the needle that hurts; if no specific needle hurts, then have the patient remove the Shen Men needle at the top – this needle is specific for stimulation of the vagal nerve.   If they still have symptoms, have them remove the Cushion needle; if still side effects, then remove the entire device.  Highly sensitive patients may not be able to wear their P-STIM device for the entire four days.   However, after several weeks, they should be able to work towards wearing the device the entire four days.

How should medications be managed during P-STIM treatment?

It is recommended that the patient’s medication regimen (including type of medication and dosage) not be changed for at least 4 weeks after P-STIM treatment has begun.  It can take as long as 21 to 28 days before the patient’s own endorphins begin to have an effect.

What types of patients are ideal for P-STIM therapy?

Any type of patient that is in chronic pain, has a strong desire to get well, can commit to weekly treatments, and has the patience to wait to see relief (after many weeks), is an ideal candidates.  This is a non-narcotic approach to pain relief and the physical and emotional aspects of the ANS are intertwined.  It is important that the patient has a positive attitude during the treatment process and to not get discouraged.  Let the patient know that this treatment process can take time, on average as much as 12 weeks and possibly even longer than 20 weeks.

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News and Events
Screening for autonomic neuropathy should be instituted at diagnosis of type 2 diabetes and 5 years after the diagnosis of type 1 diabetes - American Diabetes Association (ADA), Standard of Medical care in Diabetes, 2012
 
Dyansys successfully underwent surveillance audit and retains ISO 13485:2003 and ISO 9001:2008 certifications
 
 
 
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