Professionals’ Guide to:

Percutaneous Neuromodulation Pain Therapy

• The National Institute of Health estimates there are 50 million cases of chronic pain and 30 million cases of acute and post-operative pain in the U.S. annually
• Recent therapeutic advances offer new options for treating chronic pain. Biowave’s Deepwave® Percutaneous Neuromodulation Pain Therapy System is one such option; Deepwave is a minimally-invasive form of neuromodulation pain therapy
• Results with Deepwave continue to gain media attention, including this month’s appearance on the CBS Evening News, along with a physician interview, in the health segment ‘Eye to Eye’, with television news anchor, Katie Couric
• In this SpineUniverse interview on advances in the treatment of chronic pain, we ask the CEO, President & Founder of the National Institute of Pain, Sunil Panchal, MD, to share his insights and experience with us. A noted leader in Pain Management, Dr. Panchal’s research interests include studies on the company’s Deepwave and Homewave® devices.

SpineUniverse: What do you find most intriguing about this type of therapy for back pain?

Dr. Panchal: Having had experience with neurostimulation devices throughout my career—and I implant spinal cord stimulators—the initial attraction to me was from Biowave’s dose-ranging study, where they had a significant carry-over effect. With most stimulation devices, while they are on, patients will get relief. But when the device is turned off, they may feel better for only 45 minutes to an hour, but not much longer, and the patient then needs to have another treatment to get relief. With Biowave’s dose-ranging study, they were getting a significant number of folks who were getting relief for up to 24 hours, and that caught my attention. And that’s what really got me interested in participating with their subsequent studies.

SpineUniverse: What is the most significant advantage you have observed using these devices as compared to other therapies?

Dr. Panchal: Well, it’s easy to apply: the signals coming out of the device are optimized so there is no programming required, the invasiveness from the percutaneous electrode array is minimal, it’s well-tolerated by the patients and I would say about 75-80% of patients get relief that lasts a reasonable duration making this a very valuable therapy. Also, very importantly, this therapy avoids having to put patients on a lot of different medications. So, if I do 4 to 6 treatments in the office with the percutaneous device, and the patient gets consistently good relief, then I can prescribe for them a non-invasive home version of the device so they can treat themselves very easily as needed at home, and it can allow them to maintain good function, and have a frequency of treatment that would be conducive to an active lifestyle. If they have a good carryover effect, they don’t have to be tethered to a machine; nor do they have to take medication multiple times during the course of the day or worry about taking medication in the middle of the workday, at the office…this modality keeps people comfortable and functional and this is a good step forward.

SpineUniverse: Can you describe the mechanism of action? What process is at work, making this therapy so effective?

Dr. Panchal: Spinal cord stimulators have been around since 1967. Right now, several theories on mechanism of action have been proposed for these devices, but it’s very difficult to prove a precise mechanism in humans. We talk about the gate theory, activating descending inhibitory pathways, causing release of neurotransmitter, endogenous opioids, endorphins, etc. So, stimulatory devices may work through a variety of mechanisms, and it’s tough to prove which mechanism is the most dominant, but this holds true for most long-standing therapies. The one thing we can say is that there appears to be a difference in the duration of the effect; clearly, using high frequency signal ranges allows deeper penetration into the body, and when you start combining multiple wave forms that are delivered in and that interact with different structures in the body…then perhaps that has contributed to some of the carryover effect we are seeing.

SpineUniverse: How would you recognize a patient who might be a good candidate for this therapy?

Dr. Panchal: With neurostimulation devices like Deepwave, if they can be applied in a minimally invasive way, then you start getting closer and closer to a first-line therapy. So the question becomes more about our ability to provide relief to a patient without having to use multiple pharmacologic agents. And so there is the potential of less worrying about drug-drug interactions or drug side effects and related issues. I look at Deepwave as something you try on patients earlier in the course, so one can start looking at a wider array of patients as potential candidates. Then, if you can provide relief and maintain function without having to go to opioid therapy, for example, I think this can be a viable opioid-sparing approach.

SpineUniverse: How much training is needed for your staff to use the device?
Dr. Panchal: It’s very straightforward – there’s no programming of the device. The training is very minimal, and it’s also minimal for the patients, themselves. When it comes to the percutaneous electrodes, the placement is critical but very straightforward. The percutaneous electrode is generally placed directly over the center of the source of the pain. Good hygiene is important, so you typically use a sterile alcohol prep and then firmly press the electrode down through the skin. The electrode itself is sterile and it’s comfortable for the patient – it feels like Velcro or sandpaper to the touch. Then, connecting the electrodes to the device is via a simple leadwire cable. The patient activates the device, and usually we’ll have the patient increase the power at a rate that they can tolerate; the controls are very user friendly for them. So we are talking about minimal time for staff-involved patient training.

SpineUniverse: How do you approach a patient who may benefit from Deepwave?

Dr. Panchal: I tell the patient that stimulation devices have been around for a long time and that, while this device is new, it appears to be different in regard to the carry-over effect. I explain that my thought would be to do a first treatment, and if they have a significant carry over effect, then I would have them come in for a total of 4 to 6 treatments. We have seen that multiple 30-minute treatments spaced within 48 hours of one another produce a cumulative benefit helping to break the pain cycle. Then I would prescribe the home therapy device so the patient can continue to manage their pain with a 20-minute once per day treatment at home. Most patients are very excited about trying something they can treat themselves with and reduce the number of different medications they need to consume.

SpineUniverse: Will it prevent more invasive / expensive procedures?

Dr. Panchal: Potentially—if they get good relief early on in their therapy, this will reduce their need for other more invasive treatments and other healthcare utilization.

SpineUniverse: What kinds of pain will it treat?

Dr. Panchal: The studies that have been done so far have been focused on spine- and large joint-related issues: axial back pain, shoulder, hips, knees and low back pain. But in my clinic, I have also treated patients with other conditions successfully. I had a patient who had neuropathic facial pain in one of the branches of the trigeminal nerve, and with a single application of the device, she had relief that persisted for 2 and a half weeks. She had been blinded with respect to the expected duration of relief. I repeated the treatment, and again, she experienced another 2 weeks of relief, so she is quite satisfied with her results. I have treated other patients with cervical spine-related pain with consistently good results; and patients with pelvic pain have had reasonably good results: 24-48 hours of symptom improvement—and these patients have all requested to be moved on to home treatment with the device.

SpineUniverse: How long does a procedure take?

Dr. Panchal: What I do is apply the pads, then have the patient increase the power to the maximum tolerated level, and then the treatment at that level is continued for approximately 30 minutes. Then I remove the pads, check the sites, and discharge them. I also have them keep a diary to help assess the magnitude and duration of their pain relief. Then, when they come back for follow-up, based on those results, we may opt to do a trial with the pads placed in a slightly different configuration—sometimes this can optimize results for an individual—or, if the results are good, then it would be reasonable to continue with several additional treatments before converting the patient to the home-based therapy.

SpineUniverse: How long do patients stay on this treatment? Would they be using this device for as long as they have the pain?

Dr. Panchal: Many, many chronic pain treatments are not going to be cured and essentially you are looking at how to best manage them and still maintain function — this would be true of any of the treatments you might select for these patients — whether this is with medication, where you are trying to find the balance between pain relief and side effects, or procedures, which can yield effects that can vary considerably in duration. So, for example, if you look at someone injecting corticosteroids: most corticosteroids, if they are in depot form, will stay in the body for only 2 weeks, so some people will get relief for those 2 weeks and then it will wear off. Some people will have a carry-over benefit that may last a couple of months— the duration of response will determine whether they are a candidate for repeated steroid therapy. For others, the duration is so short that repeated steroid therapy is not a reasonable option. Even if you look at radiofrequency denervation, some people get relief for 9 months, others 1 year, and some get relief for a couple of years. But the nerves will grow back. So, whatever the etiology of pain, you may not be completely cured with most techniques—you are essentially going to be managing their symptoms with a practical approach that meets the individual patient’s goals.

SpineUniverse: Overall, how has this system changed the way you treat pain?

Dr. Panchal: I think it’s given us a very useful tool that allows us to offer a greater number of options to the patient—options that may significantly reduce their level of requirement for medications and prevent the need for more invasive courses of action. In patients with milder symptoms who are seen early on, we may be able to avoid the need for any medication. So, from an opioid-sparing philosophy, I think it’s very useful.

SpineUniverse: What has been your reimbursement experience for the Deepwave procedure?

Dr. Panchal: Reimbursement that exists with Deepwave has been reasonable. The company provided a Reimbursement Guide to our billing person that provides a description of appropriate codes, a Letter of Medical Necessity, a description of the procedure and a one-page data form to help carriers understand the new therapy, how it works, and how you’re assessing its effectiveness. But once that’s been submitted with the claim, the experience has been very positive in terms of level of reimbursement and turnaround time from submission of claim to payment.

SpineUniverse: Any additional tips or pearls you might give to a spine surgeon looking to add this system to their practice?

Dr. Panchal: In terms of trying to provide more comprehensive care to their patients, this hopefully will allow them to provide symptomatic relief while observing an opioid-sparing philosophy, which may help patients avoid side effects and the treatment of side effects. In today’s environment, with scenarios such as random urine testing factoring in, when we think about this large number of patients who end up having to be on opioids chronically, having one more tool in the armamentarium, I think, is very useful.

SpineUniverse: Is it true that the Deepwave device is being used by professional sports teams?

Dr. Panchal: Yes—I designed a study with the New York Giants utilizing the non-invasive electrodes that were available at the time to treat pain from sports-related injuries. The study with the Giants ran for about 2 1/2 years from June 2003 through December 2005. The Giants continued to use these Biowave devices [called Sportswave] following the company’s first FDA approval and once the company launched this past June, the team purchased I believe 6 systems. I have heard that there has been rapid adoption in the NFL over the past 3 months and that other NFL teams including the Dolphins, Browns, Eagles, Falcons and Jets have been increasingly using this treatment modality. Trainers have reported that players are coming into the training room and requesting Biowave over any other modality that is available to them because the response they are receiving is superior to other treatments.