Primary Relief® is our product that delivers auricular neurostimulation, a new and highly effective approach to pain management without the use of powerful narcotic medications. Primary Relief® is a wearable device that is designed to deliver continuous pulses of low-level electrical current to the ear over several days. These electrical pulses result in Cranial Electrotherapy Stimulation (CES) and are sent through three selectively positioned Primary Relief needles. The advantage of using the ear for this treatment is that it offers numerous points for stimulation for all areas of the body within a small area.
First Relief® Questions
While there are no dangerous side effects from Primary Relief® therapy, patients may experience various symptoms associated with increased autonomic nervous system activity only if they receive too much stimulation. Side effects can include: dizziness, nausea, vomiting, more pain than usual, increased heart rate and/or blood pressure, and excessive perspiration.
Patients are recommended to continue taking their medication at the same dosage for at least 4 weeks after Primary Relief treatment has begun. It can take as long as 21 to 28 days before the patient's own endorphins begin to have an effect on pain management. Please change your medications only after consultation with your physician.
Any patient who suffers from chronic pain and has seen many doctors but has not received sufficient pain relief is generally a good candidate for Primary Relief® therapy. Patients who have a strong desire to have less pain, can commit to weekly treatments, and have the patience to undergo treatment that lasts four weeks are also considered good candidates. This is a non-narcotic approach to pain relief, and the physical and emotional aspects of the autonomic nervous system (ANS) are intertwined. Because of this, it is important that the patient has a positive attitude during the treatment process and does not become discouraged. Patients should know that this treatment process could take time, with most patients seeing benefits anywhere from 4 to 20 weeks of treatment.
Drug Relief® is a percutaneous electrical nerve field stimulator (PNFS) The device is placed behind the ear and tiny needles are inserted into nerve endings in the ear. The device sends continuous electrical pulses for a period of 120 hours.
Drug Relief® is a non-narcotic treatment and is not addictive. It has been cleared by the U.S. Food and Drug Administration as safe to be used during drug withdrawal. There are no side effects and it can provide relief within 30 minutes of starting treatment.
Drug Relief® is intended to be used in the early stage of drug withdrawal as a patient goes through detoxification. It can provide relief from the symptoms of withdrawal including stomach cramps, muscle aches, muscle spasms, pounding heart, nausea, vomiting, diarrhea, agitation, depression and insomnia, along with drug cravings.
Drug Relief® is applied for up to five days at a time. This is generally long enough for the patient to go through the detoxification process to be ready for the next stage of treatment. Relief can be felt in as little as 30 minutes.
Drug Relief® is appropriate for patients over 18 who have been diagnosed with opioid disorder.
Drug Relief® can be administered by a physician or nurse practitioner as an outpatient treatment. It is available through patients under supervision of a specialist.
Since the ANSiscope® measures the activities of the parasympathetic and sympathetic systems with every new heart beat, it further becomes possible to evaluate the way these two systems function together and determine how well they interact. Based on the measurement of these activities, the ANSiscope® offers a specific measurement of autonomic dysfunction.
The patient will be required to lie down and be completely at rest, with no external stimuli. The ECG electrodes are connected to the body and readings for 512 heartbeats are taken, representing around 5 to 10 minutes. At the end of the measurement period, the ANSiscope® displays two pieces of information: a percentage that reflects the patient's autonomic dysfunction, and a classification of the patient in relation to the percentage of dysfunction.
At DyAnsys®, we firmly believe that accurate measurement of the body's system is at the core of prevention. With the use of the ANSiscope®, treatments can be specifically adapted to the condition and pain level of the patient, and help the physician gain a more comprehensive understanding of a patient's condition. Drugs acting at the sole level of nerve damage could reverse functional disorders of the autonomic nervous system (ANS) and can be determined through the ANSiscope's® instrumental measurement.
Auricular Therapy Questions
In the early 1950s, French physician Dr. Paul Nogier 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 model of the foetus – for example, points on the lower half of the body are at the top of the ear and vice versa. Auricular therapy experts in China later validated Dr. Nogier's research. The advantage of using the ear for Primary Relief® treatment is that it offers numerous points for stimulation for all areas of the body within a small area.
Your provider will make a clinical diagnosis of the pain. Once this is determined, your provider has access to several tools to determine the ideal location of the needles. Practitioners are provided with auricular charts and the ANSiscope® HRV Monitor to verify optimum placement. Once the needle locations are determined, the Primary Relief® locator helps identify specific locations of least electrical resistance.
Ideal needle locations are those areas that allow electrical stimulation to reach the free nerve endings located just beneath the skin. Often times, due to inflammation, the electrical stimulation cannot reach the free nerve endings as easily. The Primary Relief® locator 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).
Heart Rate Variability (HRV) Questions
It has been known for over 100 years that the electrocardiogram (EKG) signal contains information about the two components of the autonomic nervous system (ANS) – sympathetic and parasympathetic. This information is contained within the R-R intervals (the time between heart beats) of the EKG.
Electrodes are attached to the patient's inner wrists and ankles and the HRV test is performed. The procedure is non-invasive and takes approximately 15 minutes.
DyAnsys® has developed a proprietary technology to monitor the autonomic nervous system (ANS) from the time between heartbeats (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
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 neuropathy. Both measurements are used in the case of chronic pain.
The Autonomic Dysfunction measurement provides an overview of autonomic nervous system (ANS) behavior. Patients with chronic pain conditions may have a higher Autonomic Dysfunction value than that found in healthy individuals. As treatment progresses, their Autonomic Dysfunction values should improve.
A baseline is taken during the first patient visit for P-stim therapy and a final progress test is taken during the last patient visit. Ideally, additional progress tests should be taken on every fourth P-stim therapy 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.
This measurement reflects the instant 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.
Pain Specific Questions
Primary Relief® is based on Cranial Electrotherapy Stimulation (CES), which has been well researched since the 1950s. CES, combined with auricular therapy, has proved to stimulate a number of neuro-chemical and physiological responses that are known to relieve chronic pain and depression. The key to this relief is the stimulation and release of endorphins, which are known as the body's natural pain killers. These endorphins assist with the increase in blood flow to affected tissues, resulting in the reduction of pain symptoms. Cranial Electrotherapy Stimulation has also shown to have numerous other health benefits.
The Primary Relief® has been effectively used to treat a number of chronic 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 related aliments. Ask your provider if your condition is appropriate for this treatment.
In addition to the Primary Relief® treatment, a Heart Rate Variability (HRV) test using the ANSiscope® HRV Monitor will be administered to correctly assess the patient's level of autonomic dysfunction and autonomic nervous system (ANS) balance.
Studies have shown that patients with chronic pain will have their ANS balance skewed towards the sympathetic nervous system, which promotes body action. As treatment with the Primary Relief® progresses, the goal is that the patient's level of ANS balance will improve by moving towards the parasympathetic nervous system, which promotes body relaxation. The ANSiscope® will also be used to optimize placement of the Primary Relief® needles during each treatment.