Professionals’ Guide to:

Percutaneous Neuromodulation Pain Therapy

Recent therapeutic advances are generating promising new options for treating chronic pain, and Biowave Corporation’s Deepwave® Percutaneous Neuromodulation Pain Therapy System (Deepwave) is one such option that continues to gain recognition.

Deepwave is a percutaneous form of neuromodulation pain therapy that was featured recently on the CBS Evening News with anchor, Katie Couric, in the health segment and in an “Eye-to-Eye” physician interview. Both segments were part of a week-long focus on conditions affecting the aging baby boomer population and current treatments.

Professional sports teams adopting the technology developed by Biowave Corporation may also be raising awareness. The New York Giants were the first NFL team to use Biowave’s Sportswave® for sports-related injuries earlier this year, and the list has since grown to include the Miami Dolphins, Cleveland Browns, Philadelphia Eagles, Atlanta Falcons and New York Jets.

Designed and developed by Biowave Corporation, the Deepwave System has FDA indications for symptomatic relief of chronic intractable pain, acute pain and post-surgical pain. Clinical studies have shown that following a 20-30 minute treatment, benefits include an immediate 75% average reduction in pain and a significant increase in function, including an increase in range of motion, reduction in muscle spasm and a reduction in stiffness, all of which last for up to 24 hours post treatment, without the side effects that are common to drugs, injection therapies, surgery and implanted devices.

Biowave's patented percutaneous electrode array (PEA) is a microneedle patch technology that facilitates the delivery of electronic feed signals through the skin directly into deep tissue encompassing the pain site. The feed signals are composed of a premixed set of high frequency wave forms. As the feed signals pass through the body between an opposing electrode generally placed opposite the pain site and the PEA located directly over the pain site, polarized structures and in particular, nerve fiber membranes, that lie along the path in the body between the PEA and opposing electrode act like nonlinear devices, causing the feed signals to mix. The result is the formation of a low frequency electric field, which is believed to interrupt transmission of pain impulses by preventing action potential propagation along pain fibers – a similar mechanism to local chemical anesthesia, except without any deleterious side effects.

Noted pain expert and principal investigator, Sunil Panchal, MD, remarked that it was the duration of relief with Deepwave that initially caught his attention. Having had extensive experience implanting neurostimulation devices, Dr. Panchal took notice when a dose-ranging study with Deepwave showed a significant “carry-over effect.” That is, a significant number of patients were getting relief for up to 24 hours. Dr. Panchal explained that with most stimulation devices, patients experience relief while receiving treatment—and perhaps for another 45-minutes-to-1-hour—but not much longer. In contrast, Dr. Panchal’s experience with Deepwave supports a significant carry-over effect.

Spinal cord stimulators have been around since 1967, but according to Dr. Panchal, it’s very difficult to prove a precise mechanism in humans, and several theories on mechanism of action have been proposed. He observed that the one thing that appears to be different with Deepwave is the duration of the effect, noting that use of high frequency signal ranges allows deeper penetration into the body, and he theorized that the combination of multiple waveforms may have contributed to some of the carryover effect observed.

Biowave Vice Chairman, Chief Technology Officer and founder Brad Siff has remarked on the importance of a delivery platform that enables the formation and targeting of a low frequency electric field in deep tissue which is optimized to inhibit pain transmission and improve function.

Siff said the version of the system used in doctor offices, called Deepwave, received marketing clearance from the FDA in 2006 as a percutaneous electrical nerve stimulation (PENS) device, only the second PENS device ever cleared by the FDA. Deepwave utilizes a patented percutaneous electrode array (PEA), which is a sterile, 2.5 inch diameter, single-use electrode with more than 1,000 tiny needles that are 3/4 of a millimeter in length and feel like sandpaper on the skin. The outer layers of the dermis are about 1/4 of a millimeter in thickness so the PEA directly can deliver the therapeutic signals into deep tissue overcoming all of the impedance and capacitance issues associated with skin. Because of the PEA’s design it can easily be contoured over uneven surface areas on the body making it flexible to deliver therapeutic stimulation to numerous locations.

The signal technology is also covered by numerous patents. Biowave’s devices deliver a pre-mixed set of high frequency signals through a feed electrode which travel through the body to an opposing electrode (the PEA) placed directly over the center of the pain site. Early testing demonstrated that as the signals pass into deep tissue, polarized structures like the wall of the C-fiber and muscle tissue cause a Fourier Transform, forcing these signals to further multiply together resulting in a new spectrum of signals inside the body. One of the new signals formed in deep tissue all along the path inside the body is a low frequency signal that empirically inhibits transmission of pain signals on the pain fibers and keeps the muscle held in isometric contraction, a comfortable tingling and pressure sensation that is felt by the patient. The use of 2 different sized electrodes and the combination of a PEA with a non-invasive electrode, allow the targeting of the low frequency field into a 2-3 inch diameter volume directly under the percutaneous electrode, which encompasses the pain site. Two PEA’s can also be used simultaneously delivering an equal strength low frequency electric field underneath each electrode allowing for the treatment of bi-lateral low back or cervical pain.

The empirical result in clinical trials has been similar to that of a spinal cord stimulator, but without the risk of surgery or the expense.

The Sportswave® and Homewave® devices which have received separate clearances, use the same signal technology but with a different non-invasive electrode that does not penetrate the skin. While not as efficient as a percutaneous delivery system, the signals still travel into deep tissue and provide substantial pain relief and functional improvement. Siff said the smaller Homewave unit’s non-invasive electrodes can be re-used up to five times making it more economical for home use.

What does Deepwave mean for patients, clinicians, and staff? Physicians using Deepwave have remarked that the process is very straightforward. There is minimal training for patients and staff. The device is very user friendly, there is no programming required as the signals being delivered from the device are optimized for blocking pain. The treatment site under the percutaneous electrode array (PEA) needs to be prepped with isopropyl alcohol prior to the PEA being applied to the skin. Electrode placement is critical but generally straightforward with the PEA being placed over the center of the source of the pain. A laminated quick reference card illustrates different electrode placements for different locations on the body. Once the pads are applied under the supervision of the physician, the nurse, PA or PT explains the intensity control to the patient and the patient increases the intensity controlling their own comfort level. Patients are encouraged to get above 20.0% of maximum intensity to ensure they will receive an adequate response. Generally it takes 3 – 4 minutes for the patient to ramp up to a therapeutic level that is strong but still comfortable for them. During the remainder of the 30 minute treatment, patients will often slightly increase the intensity. Experience has shown that patients’ bodies do not accommodate to the signal over time. For a given electrode set and placement location on the body, if a patient gets to 42.5% of maximum intensity, for example, in their first treatment, then they will generally get to within +/- 10% of that level on all subsequent treatments.

On subsequent treatments in the physicians office, electrode placements can be adjusted to optimize results for individual patients based on the results of the first treatment. Once treatment is optimized, patients continue with up to a total of six 30-minute treatments in the physician’s office, typically spaced 48 hours apart, to provide a cumulative benefit and break their pain cycle. Following successful Deepwave therapy, patients can purchase the smaller non-invasive Homewave® prescription device to continue to manage their pain at home on a once per day or as needed basis.

To learn more about the Biowave Corporation, its approach to pain management, and the science behind the percutaneous technology, visit: www.biowave.com