Claim your offer for $200 OFF! Offer Expires in CLAIM NOW!

Appointment Request

Please fill out this form and we will contact you about scheduling. Questions? Call 717-727-1707

It’s 50 and 50 for Erectile Dysfunction: IWG Team on iHeart Radio

Catch up with Innovative Wellness Group as they discuss the drug-free and surgery-free alternative treatments their clinic provides to combat Erectile Dysfunction, chronic pain, and sports injuries. From Acoustic Pressure Wave Therapy to the Vagal Neurostimulator device, striving for an increased quality of life for patients through holistic means is what it’s all about.

erectile dysfunction

MICHAEL: We’re going to be talking about pain and pleasure, and you’ll understand more as we get into the topic. Joining us is Phil and Robert, and they are with Innovative Wellness Group. You’ve been hearing their ads a lot on our radio stations, not only WHP580, but all of our iHeart radio stations, talking about how they can help you deal with pain, whether it’s chronic pain, getting old, sports pain, and also when it comes to pleasure, as in Erectile Dysfunction. We will get into all those topics and more, and you’ll find out what we can’t describe in 60 seconds, 30 seconds, 15 seconds on a regular ad, and use this time in the long-form to learn more about them. So, first of all, let’s talk a little bit about Innovative Wellness Group and what you’re all about.

ROBERT: We’re a health clinic new to the area of South Lebanon down in the medical district, on the south side right off Cornwall Road. We specialize in the treatment of chronic pain, sports injuries, and Erectile Dysfunction.

MICHAEL: How did you decide to start this group?

ROBERT: I’m going to pass that over to the owner of the clinic, Phil, and let him tell everybody how he got into this.

PHIL: Really, to make a long story short, I have a friend of mine that lives out in Southern California, and he has a clinic specializing in E.D., so I flew out and met with him back in the first part of July. I did a lot of research, read a lot of information, and made the decision to open up the clinic on the south side of Lebanon. I thought it would be a good fit for central Pennsylvania, found a nice area, and that’s what we’ve been doing.

MICHAEL: We know you originally from your work when it comes to E.D., but recently, we’ve also been focusing on pain management. Is it the same kind of therapy treatment, or is it two totally separate things?

ROBERT: Well, that’s an interesting question. Both of them help with pain. When it comes to sports injuries and Erectile Dysfunction, we use something called Acoustic Pressure Wave Therapy. On the chronic pain treatment side, we use some new technology called Neurostimulation. So, two different devices, two different types of things that the clinic does.

MICHAEL: It’s kind of interesting, when we were working with these guys, and these guys are open to pretty much anything when it comes to advertising and marketing, and Hannah’s in the studio with us and she’s the Account Executive and their marketing representative for iHeart, and we were talking about this wave technology, and I said to Hannah, “How about I take the sound effect of a Star Wars light saber?” and she says, “Hey, they would go for that!” When I first heard “acoustic wave,” that was the first thing, and you’re trying to make radio advertising theater of the mind. After that came across, we’ve been getting the most comments on that. But, when it comes to technology, as Phil mentioned, too, is that you traveled across the country because of the new technology that’s coming out. When it pertains to E.D., it was that the only treatment was the pill, and now, there was this acoustic wave. Basically, I’ll let you describe it, but E.D. is caused by not enough blood flow, and this opens up the blood flow.

ROBERT: Correct. Acoustic Pressure Wave Therapy is not new technology. I’m a nurse, and this technology has been used since the ‘80s for treating kidney stones. The machine we use is called “low intensity,” which just means the beam of it spreads out and sends the waves in a wider area, where treating kidney stones is “high intensity,” but it’s the same technology. You just mentioned that Erectile Dysfunction, over 90% of it is caused from blocked blood flow to the area. What Acoustic Pressure Wave Therapy does is break up the occlusions because as we age, we get plaque that builds up in our veins and arteries. For most of us, it’s not that big of a deal, but eventually, we end up getting a chest pain or something and go to the family doctor, and he refers you to cardiology, and before you know it, you’re in getting balloons and stints put in because of that blockage. Well, the same thing is happening down in your groin and your penis, and we have to get that blockage removed, and Acoustic Pressure Wave Therapy breaks up that plaque, allowing your body to naturally process it and excrete it. Now, there are side benefits to it. It also creates a micro trauma to the area, and the benefit of that is that it creates new cell tissue growth and new nerve endings. So now, through the series of treatments, we’re going to get that blood flowing where it needs to, because let’s face it, your groin and your penis are highly vascular, so once we get that opened up, the blood can flow unrestricted, engorge the penis, allowing it to become rigid so that you can successfully complete intercourse and end with a now pleasurable-feeling orgasm the way it did back in your 20s.

MICHAEL: That’s really cool. Not to shift away from this, but you talk about how this wave therapy works with kidney stones and how it vibrates it shut, I’ve told my hygienist for years, because I hate to floss, I say, “Why can’t you all just have one of those things where you put my head into this giant thing and it shakes my head and loosens all the plaque and it all falls out?” And she said, “You might be on to something here!” So that’s our next thing, Phil, we’re going to work on this. But, going back to seriousness, I think that explains everything. I guess the problem that you have as a group and a business and we have as men, speaking as a whole, is that a lot of us men won’t seek help. Men won’t seek help to get a cut stitched, or anything else like that, so is that the biggest burden of having men talk about this?

ROBERT: Well, I think because we’re in such a conservative area, it’s almost taboo. Probably a third of our clients, when they call in, you can tell by the tone of the conversation that they’re embarrassed to be talking about it, so I always try to relax them and say, “Listen, I’m a nurse. I’ve seen it all, I’ve done it all, I’ve experienced it all with these people, and it’s okay, you can tell me. I have to ask you personal questions in order to explain things in a manner that you’re going to understand or that pertain to you.” That is a big hurdle, but normally by the end of the conversation, they can reflect back and say, “I’m glad I made this call, and I’m glad I was able to open up.”

MICHAEL: I think that was one of the things, too, that we were talking about before we went on was that we don’t want this to sound too sterile and scripted, but that’s not our program. I said that what’s great about you guys is that you have a sense of humor and you make people feel relaxed. I think that’s very, very important, especially when it comes to men approaching a medical facility. They want to be in the position, maybe not so much like a locker room but pretty close, where you just want to feel relaxed and you want to be open and talk to guys about this stuff, get advice, and then, most importantly, get these things solved.

ROBERT: Correct.

MICHAEL: The Erectile Dysfunction thing, I think you mentioned how much of the male population is affected, close to 50%?

ROBERT: It’s 50 and 50: At 50 years of age, over 50% of the male population either has Erectile Dysfunction or is starting to get Erectile Dysfunction.

MICHAEL: What are the advantages of your treatment over a pill?

ROBERT: For over 50% of American men who have tried Viagra, Cialis, Levitra, etc., it doesn’t work for them. The reason it doesn’t work for them, as I said earlier, is that they have these occlusions, they have this plaque that is built up in the veins and arteries. Since it’s restricted, and what those products and pharmaceuticals will do is mess with your blood pressure to try to give you the erection, but it doesn’t work because you can’t get the blood flow no matter what you’re going to do. They are prime candidates for us. Then there is the population that use it and it kind of works or does work, but they can’t stand the pharmaceutical side effects: the flushing, the dizziness, the blurred vision; and they don’t like the fact that they have to plan hours ahead of time, with an “Okay, I’m going to be popping this at 5:00 so that by the time I’m done with dinner, I’m ready to do the deed.”

MICHAEL: From a female standpoint, that could have an impact, too. We look at the women who are looking for that time together, and then you have to plan everything and schedule it. And we all know, married and everything, you realize how busy the schedule is, so this is definitely a good solution. Do you get a lot of women, or would you recommend the wife or spouse, to come with them to the consultation?

ROBERT: Absolutely. That’s one of the great things about what we do in helping men with E.D. I realize only one person is getting treated, but two people are reaping the benefit. I don’t know of anything else in the medical field that you can do for somebody that, even though there’s one person getting treated, many people receive benefits from it.

MICHAEL: Learn more by going to the website at innovativewellnessgroup.com or calling at local number (717) 727-1707. I’m going to switch gears here, as we’re about half way through, because while we’re talking about Erectile Dysfunction and how about 50% of males go through this, a lot more people are dealing with pain, chronic pain. Innovative Wellness Group does not just focus on E.D. and men, you’re helping people ease pain. How are you doing that?

ROBERT: I’m happy to say that we are one of the first clinics in Pennsylvania that has some new technology. It’s called a Vagal Neurostimulator, and it’s a tiny little device that attaches to the vagus nerve in the oracle of your ear with a little wire that’s attaches to a device that’s taped underneath your collar line. What it does is sends and electrical impulse to the base of the brain and, in simple terms, what it does is immediately relieves 50% or more of your chronic pain as soon as it’s turned on because it stimulates that vagus nerve which goes throughout the entire body through your parasympathetic nervous system. So, as soon as you turn it on, people are elated because the pain goes away, and they can wean themselves off their pharmaceutical products that a lot of them don’t like taking anymore because it is an opioid and they don’t want to be a person that’s addicted to them. We are starting that very shortly and we look forward to helping a lot of people with their chronic pains, whether it’s lower back pain, neck pain, any kind of neuropathy, or migraines, which are a big one that will benefit from this. Chronic pain treatments are another specialty of ours.

MICHAEL: Explain it to me again about this nerve and how your doing this through the ear?

ROBERT: You have approximately 60,000 fibrous bundles in your body that are attached to the 10th cranial nerve in your neck into the base of the brain. So this (device) sends a very low frequency electrical stimulation to that, telling it, “hey, we’re going to block this. There’s no more reason for you to be suffering from this pain,” and it blocks the parasympathetic nervous system from the pain receptors, the nico- receptors. By doing that, it immediately relieves pain. It’s not a gradual thing. As soon as it’s turned on, the pain is instantaneously relieved.

MICHAEL: Would it be similar to the TENS units?

ROBERT: It’s kind of the same technology. It’s the same thing in that it works off of a specific frequency, but this is different because every nerve bundle works off a different frequency.

MICHAEL: You’re really focusing on getting very, very specific.

ROBERT: Correct.

MICHAEL: This obviously takes the pain away, but does this treat the actual cause? Is that good or is that bad? You’re easing people of pain, but if there’s something wrong with you…

ROBERT: Right. Well, a lot of people have gone through a surgery to correct the pain, but because the nerves are still sensing the pain, there is no actual pain there, it’s just that the nerve thinks there is. So we’re getting rid of that for them so that they don’t have that pain anymore.

MICHAEL: Sports injuries, let’s talk about that. We have a lot of Weekend Warriors out there. In fact, right now I’m going through doing a little number on my knee while going out for a run, but a lot of people are suffering, or they were athletes and are still going through that pain. You can help them when it comes to sports pain as well, correct?

ROBERT: Absolutely.

MICHAEL: Would it be the same thing we were talking about before when we were talking about the chronic pain?

ROBERT: No, the treatment for sports injuries would be the Acoustic Pressure Wave. It’s great for helping things like tennis elbow or golfer’s elbow, which is basically the same thing, plantar fasciitis of the feet (it is most successful at treating plantar fasciitis), carpal tunnel (a lot of the people that work at factories or secretaries doing constant movement of the wrist, it’s very successful at treating that). There is a lot of great reasons to do it because it’s non-invasive, there’s no down time, you’re not going to have any time off of work, and there’s no side effect to it.

MICHAEL: That’s one of the things I wanted to talk to you about, Phil, with the Innovative Wellness Group. Would holistic be a good way to describe your practice?

PHIL: Very much so. Our focus as a group is really to treat pain and things like that with something that’s a non-pharmaceutical type of treatment versus simply prescribing opioids or medications or things like that. We’re really trying to get away from how typical medicine approaches those issues and go with a holistic type of approach.

MICHAEL: That is the big topic right now, as we talk about opioid abuse, more often than not, this isn’t the drug dealer or junkie on the corner, these are athletes, school board presidents, and things like that, and they get addicted to pain killers because they had a bad pain experience and got hooked on the drug. This is where a holistic approach would be beneficial. When it comes to sports injuries, could you give a testimonial to someone that you’ve helped recently?

ROBERT: I have a state police chaplain that stands on his feet a lot, and he has had surgeries in the past on his feet, and he has plantar fasciitis horribly, horribly bad. After one treatment, he stood up and put his shoes on, and said, “Wow. I feel like I’m standing on a cloud.” He was just amazed at how quickly the Acoustic Pressure Wave, or Shockwave worked. When I say “Shockwave,” I’ve had a few customers that have talked to me on the phone think I’m talking about a cattle prod-type thing and I’m literally shocking them, but that’s not the case. But yeah, plantar fasciitis, he got the treatment, and just after his very first treatment when he was getting his shoes back on, he said, “Wow. I feel like I’m standing on a cloud, and I haven’t been without pain in my feet for so long that I forgot what it feels like.”

MICHAEL: When it comes to chronic pain like this, I guess a lot of people out there will say, “Alright, this all sounds great, but how am I supposed to pay for it?” Is there insurance coverage when it comes to chronic pain, Phil?

PHIL: Insurance typically does not cover things with Acoustic Pressure Wave Therapy, however, they will cover it on the chronic pain side with our Neurostimulator device. We just talked about knowing anyone that has had results with this, and I’ll tell you for myself, when I was 12, I had a horse run over me and ripped out all the ligaments in my right knee, and it was supposed to heal back correctly, and it didn’t. I’ve had a lot of pain in that knee, especially the last couple of years. I did six treatments on this and it took the pain level in that knee from an 8 or a 9 down to a 1, and most days I don’t even think about it. It totally got rid of the swelling.

MICHAEL: So, as we wrap up, Robert, tell folks what Innovative Wellness Group is all about and how they can help us.

ROBERT: The best thing we can do for you is take care of whatever ails you when it comes to pain and do it from a holistic approach. We do not promote the use of pharmaceutical products, and in fact, we want to help you get off of them. So, if you’re a very active person and you’re looking for a modality that’s outside the normal thinking, we’re your group because we can treat whatever injury you have in the body, and if it’s chronic, we can help you relieve that pain instantly with something that’s totally covered by Medicare, Tricare, and things like that with no out-of-pocket expense. We think that we’re centrally located to the Harrisburg, Hershey, Redding, Lancaster areas, and we really enjoy seeing the results and seeing people getting treated, and then they share their stories with us. It’s very gratifying as a nurse to be providing treatments for people and getting that positive feedback. It makes you feel like you’re really making a difference in people’s lives.

MICHAEL: It’s the reason you get up in the morning.

ROBERT: Yes, and quality of life is really what it’s all about. When you can improve somebody’s quality of life, that’s our goal.

MICHAEL: You are absolutely right. We’re all getting older and there are pains we thought would never come, but they’re coming, they’re happening. When it comes to E.D. as well, men, women, if you have a problem with that, consider the options that are available at Innovative Wellness Group.

Request a FREE information packet or to schedule a consultation. Follow Innovative Wellness Group on Facebook and Twitter to stay updated!

 

 

 

Tennis Elbow High Energy ESWT a study from Orthopedic Technologies & Techniques

ESWT Treatment for Chronic Lateral Epicondylitis Study Recap

The protocol that we are now using for CLE is a high-energy one-session treatment protocol. The protocol that we are using is from a just recently published article in the American Journal of Orthopedics written by John Furia MD. Dr. Furia is an orthopedic Sports Medicine Specialist. The Dornier Epos Ultra the equipment used. We now have a reference for CLE treatments from an American published journal.

Dr. Furia served as the team physician at the amateur and professional level since 1990. He has served as the team physician for: Bucknell and Rochester Universities, Houston Oilers, Houston Astros, Houston Rockets, Rochester Americans (AHL Hockey), US Amateur Boxing and at the high school level with Westbury and Greece-Olympia’s football teams.

The Roles Maudsley results at the 12-week follow up were 78%. This is much better then the 62% for plantar fascia at the 12-week follow-up. Remember that the nature of healing tendons/plantar fascia is getting better with time. Expect better results at the six-month and one year follow for CLE, as is the case with plantar fasciosis.

It can take up to 4 weeks for improvement with CLE after High Energy ESWT Treatment. Patients need to avoid gripping and torque/twisting tasks for three weeks. In Dr. Furia’s report all work compensation patients returned to work in one week. Return to sports was allowed as the symtoms were reduced. Patients were allowed to return to work and sports, as they felt better.

Average VAS scores were the following Pre- Treatment: 8.0 ESWT/4 weeks: 4.0 ESWT 12 weeks 2.5

Roles Maudsley Scale
4 weeks Excellent/Good: 69.5 % Fair 19.4 % Poor 11.1 % (note poor means there was no change. There were no patients made worse off in this study.)

12 weeks. Excellent/ Good 78% Fair 11.1% Poor 11.1 % Note that patients moved from fair into excellent/good or improved from week six to week twelve. There was a shift of almost 10% from the fair into to the good/excellent group. The poor remained the same.

There was no second treatment offered during this study.

We know that additional treatment was beneficial from our own ESWT Plantar fasciitis treatments. If a patient is doing fair or poor at the 12-week mark and not getting better a second treatment should be considered.

Interesting facts – 50% of all tennis players will have CLE – 16% of all work compensation cases are CLE – In this study the return to work from a workman’s comp case was one week. This is dramatically different then if surgery was used – Pain reduction continued to improve from week six to week twelve which falls into the classic tendonpathies healing pattern

Shocking Relief: New Therapy Eases the Chronic Pain of Many Common Tendon Injuries

article from Newark Star-Ledger

Mary Jean Lange’s first steps each morning were so excruciating that the Hackensack teacher resorted to crawling to the bathroom. Betty Davis, an Irvington nurse, felt like the soles of her feet had been branded. Jean Smitchger, a retired businesswoman from Cornwall, N.Y., dredged up only two little words to describe the pain: “all hell.”

The three women suffered from plantar fasciitis, a swelling of the tough tissue on the bottom of the feet. Seen often among workers who have to stand on hard surfaces all day, it strikes about 2.5 million people a year. For most patients, rest, ice, stretching, special insoles or cortisone shots do the trick, but for these women, nothing short of surgery seemed to help.

Finally, their podiatrists recommended a new treatment for chronic heel pain called extracorporeal shock wave therapy. An ESWT machine sends acoustic waves into the foot, which bruises the already battered tissue. Doctors believe that these new microscopic tears promote the growth of new blood vessels, effectively jump-starting healing that had been stalled.

Davis just calls it “my miracle.”

First used in the Europe to break up kidney stones, shock wave therapy jumped the pond in the 1980s and now is standard care for kidney stone sufferers. Since the Food and Drug Administration approved the first ESWT machine for treatment of plantar fasciitis in 2000, the therapy has taken off. Without the risk or complications of surgery, most patients are back on their feet within a day or so, some reporting immediate relief.

Now doctors use shock waves to repair many common tendon injuries, including tennis elbow, Achilles tendonitis, shoulder, knee and wrist tendonitis, and trigger finger, reporting success rates of about 80 percent.

Some major insurance companies, however, do not cover the treatment or cover it only for some tendon injuries. Aetna deems it “experimental” and will not pay for it. Horizon Blue Cross Blue Shield covers the therapy for plantar fasciitis only. The cost runs about $2,000 to $3,500.

But research in Europe and Japan shows shock wave therapy holds further promise. Doctors have been using it to heal diabetic ulcers and to fix bone fractures that have not healed properly, which alleviates the need for complicated and painful bone grafts, said podiatrist Kimberly Eickmeier, a spokeswoman for the American College of Foot and Ankle Surgeons and an adviser to the International Society for Musculoskeletal Shockwave Therapy.

A Japanese study published last year in the journal Circulation showed that shock waves repaired heart damage in pigs, suggesting that it could be used to help healing in humans after heart attacks.

The German firm Dornier developed medical shock wave technology after aircraft engineers noticed pitting in the aluminum of the stabilizer wings of airplanes breaking the sound barrier. Legend (among medical historians, at least) has it that one of the engineers mentioned the phenomenon to a surgeon over a beer, and they speculated that shock waves could be used to break up kidney stones.

Later, a patient in Europe who was to be treated with shock waves for his gallstones asked the surgeon to test the machine on his heel pain, and the doctor did, according to Eickmeier. (Picture that in America: “Dude, while you’re fixing my eyes, how about zapping my hernia with that laser?”) It worked, and word about the treatment spread quickly.

Doctors typically recommend the procedure if patients are still in pain after six months of conventional therapy. The outpatient procedure takes only 10 to 20 minutes, longer if the patient must be sedated first. The injured area is coated with gel and placed against the therapy head, a rubber dome filled with water. The machine generates sound waves that emanate through the membrane and into the injured area.

Two types of machines, the HealthTronics OssaTron and the Dornier EPOS Ultra, target the injured area with high energy sound waves. This can be painful, the feeling has been likened to getting hit with a baseball bat, so a nerve block is applied to the injured area. Many patients also undergo, “twilight sedation”, in which patients remain conscious to avoid discomfort. The one-time treatment usually takes place in a hospital or surgery center.

Another machine, the Siemens Sonocur Basic, uses low-energy sound waves, so it can be performed without anesthesia in a doctor’s office. It usually takes three visits to repair the damage.

The success rate compares with that of surgery, but it does not carry the risk of infection or require stitches. Patients typically get back to their normal routines much faster.

“The worst thing that happens here is it doesn’t work,” said Maplewood podiatrist Howard Hyman, as he watched technicians administer the treatment to a patient’s right foot (the one with YES written on it) earlier this month at the Surgical Center at Millburn.

There’s actually one thing that’s worse: Paying out-of-pocket for the treatment and it doesn’t work. Although proponents say they see shock wave therapy becoming standard care for tendon injuries, particularly among worker’s compensation cases, many insurers will not cover the procedure.

Some patients who got their tennis elbow by actually playing tennis as opposed to working stiffs who got their injuries by cutting meat, fixing plumbing or painting houses, don’t balk at paying for the treatment themselves.

After the pain in her foot pushed her into a wheelchair, Smitchger was more than willing to gamble $3,500. “I was at my wit’s end,” she said. “I’d try anything.”

There is nothing about the treatment, however, that can prevent the patient from reinjuring the tendon. Doctors recommend ways to avoid reinjury, from losing weight for a heel pain sufferer to changing tennis rackets for a patient with tennis elbow. And some patients do not respond to the treatment at all.

Jeffrey Gross, a Manhattan doctor specializing in physical medicine and rehabilitation, served a number of patients who had been suffering from the same injury for years with little improvement. He followed the FDA approval process of the low-energy Sonocur machine closely, and within a month of its okay in 2002, he had one in his office.

He has since treated more than 900 patients with the device, including pro basketball, hockey and tennis players, and college and high school athletes.

“There are patients who will get better if you wave a wand over them because of the placebo effect,” he said. “I am certain there is no placebo effect acting in these people. They get better.”

ESWT Used to Treat Several Types of Tendonitis

article from Newark Star-Ledger

Tendons are strands of fibrous tissue that connect muscle to bone. They can become inflamed by overstretching or small, repeated stresses.

Most tendon problems can be treated with rest, ice and stretching, according to the American Academy of Orthopedic Surgeons. If pain persists, a doctor may recommend orthotics (shoe inserts), cortisone shots or a splint or walking cast. For those patients whose pain persists after six months of conventional treatment, Extracorporeal Shock Wave Therapy may be an option.

ESWT has been used successfully to treat several common forms of tendonitis, including:

Plantar fasciitis (also called heel spurs):

Inflammation of the connective tissue on the bottom of the foot. It is more likely to occur if you are overweight, if you walk a lot or stand on hard surfaces, if you walk or run for exercise or if you have very flat feet or very high arches.

The condition starts gradually with mild pain. Without treatment, it can become more severe, with acute pain in the first steps after waking and after exercise.

Lateral epicondylitis (tennis elbow):

Degeneration of the tendon that attaches the outer side of the elbow to the muscles that extend or lift the wrist and hand. It is occurs with repetitive use of the forearm muscles, so it strikes workers as well as athletes.

The pain can progress to a severe, burning feeling on the outside of the elbow and is exacerbated by gripping or lifting even very light objects. The pain can radiate to the forearm.

Achilles tendonitis:

Inflammation of the tendon that connects the heel bone to the calf muscles. The Achilles tendon is the largest and strongest in the human body, and also the one most frequently ruptured.

Achilles tendonitis can be brought on by runners who rapidly increase their mileage or speed and exercisers who add hill running or stair climbing to their routine. The pain starts off mildly and gradually worsens. Sufferers can feel tenderness in the lower leg in the morning, stiffness and swelling.

Patellar tendonitis (jumper’s knee):

Inflammation of the tendon that connects the quadriceps muscles to the shin bone. It is more common among athletes who jump, including basketball and volleyball players.

The pain, just below the kneecap, is often sudden, occurring just after working out, landing from a jump or going up or down stairs.

Supraspinatus tendonitis (rotator cuff tendonitis):

Inflammation of the tendon that connects the upper bone of the arm to the shoulder.

Symptoms include shoulder pain, especially with movement and at night, weakness in the arm and shoulder, and a snapping sensation in the shoulder with movement tenderness.

Extracorporeal Shockwave Therapy: The Dornier Epos Ultra -Level One Evidence

David Zuckerman DPM
Excellence Shockwave Therapy

It has been over 17 years since I first was introduced to the extracorporeal shockwave therapy (ESWT) for the treatment of plantar fasciosis and other forms of tendinopathy. Is ESWT still the best treatment for tendinopathy? Are there any new clinical studies about this treatment? Are there other products that FDA has approved? In fact, some devices on the today’s market are now being labeled as ESWT devices which aren’t even indicated for the treatment of foot and ankle diseases [4].

ESWT is a treatment involving shockwaves or high energy pulses created by an electromagnetic coil or a spark in water. These pulses are started externally to the body and transmitted via a special pad directly into the skin. This high energy treatment is used successfully all over the world in orthopedics, podiatry, physical therapy, urology and cardiology. Unfortunately, I have also observed the improper use of mislabeled ESWT equipment in podiatry and orthopedics over the years. Doctors and patients need to be educated in identifying proper ESWT equipment and accurate usage [4].

My primary goal is to educate podiatrists and orthopedists the importance of choosing an FDA approved, Class 3 device with Level One Evidence [5]. It may be unethical for a doctor to simply recommend one brand of device without controlled studies or approval by FDA. The FDA has a role to ensure both safety and efficacy in today’s consumer driven healthcare market. This includes control and supervision of medical devices as well as monitoring physician advertising. Evidence-based medicine is the key to our future as physicians and scientists. Our patients deserve this consideration. The 100s of studies over the years on ESWT speak for themselves.

The Dornier Epos Ultra device is based on sound science and received FDA clearance in 20022. The Dornier device is considered the gold standard among other ESWT devices in terms of positive long-term patient outcomes, as shown in several well-designed peer-reviewed studies in the U.S. over the past 15 years [1].

Dornier Medtech is the original company that pioneered and developed both kidney stone lithotripsy and orthopedic lithotripsy for the treatments of tendon conditions and plantar fasciosis.  Researchers carried out a one-year study in Harvard Medical School, Emory Medical School, Henry Ford Hospital and Kennedy-Fowler Sport Clinic. This was multicenter double-blind randomized controlled trial [1]. Pain was assessed by using VAS and Roles Maundley scores. One hundred fifty four patients participated. The result showed that on average the pain level reduced by 92%. In addition, 94% of the patients reported that their symptoms improved significantly. Placebo controlled patients were treated and unblinded at the 12-week endpoint [1].

A follow up study known as the North American Confirmatory Study was conducted in 2003. It had the same outcomes. Initial FDA approval was also obtained from these studies. The most recent advertised “shockwave” devices, EPAT and Zimmer, are not currently FDA approved for orthopedic treatment for foot and ankle diseases. They are only simple massage devices [4].

In my experience, the Dornier Epos Ultra is proven to be more effective than other devices because it relies on ultrasound principles. The practicing physicians can actually observe the pathogenesis and focus on the degenerative areas along the tendon. Dosage of energy in the tissues is monitored and recorded in the chart. Clinical effectiveness depends on proper selection of patients as well as optimum dosage of the shockwaves by users.

Patients expect to have good long-term outcomes and long-term relief from pain. Wang showed that there was less than 10% re-occurrence of pain after receiving high energy ESWT treatments over a five-year period [6].

In conclusion, it has been shown and proven through peer-reviewed scientific publications that the Dornier Epos Ultra is an effective FDA-approved device. A full treatment only takes 30 minutes or less and it can be done in an outpatient setting. The Dornier device has been approved by FDA and has had a track record of over 17 years with Level One Evidence. I conclude that the Dornier Epos Ultra is the best device for treating patients with tendinopathy.

David Zuckerman DPM Excellence Shockwave Therapy

References

  1. Theodore, G., et. al. (“Extracorporeal Shock Wave Therapy for the Treatment of Plantar Faciitis.” Foot & Ankle International , Volume 25, No. 5:290-297
  2. Dornier Medical Systems, Inc. (2002). Dornier EposTM Ultra summary of safety and effectiveness, PMA #P000048. Provided by fax from Dornier on December 9, 2002
  3. Kudo, Patricia, et al, “A Randomized , Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Plantar Fasciitis with an Extracorporeal Shockwave Therapy Device.
  4. Public Health Service – Food and Drug Administration to the President of Storz Mdedical Ag, 2010, in Warning Letters. D-Actor® 50 and D-Actor® 200 devices. Last updated May 2010. http://www.fda.gov/cdrh/devadvice/3122.html.
  5. American Academy of Orthopaedic Surgeons, 2008. Levels of evidence for primary research question.
    • Level I: Highest (blinded, randomized, placebo-controlled)
    • Level II: Non-randomized, placebo controlled
    • Level III: Non-randomized, case-cohort, prospective
    • Level IV: Retrospective
    • Level V: Expert Opinion
  6. Wang, Chin Jeng, MD, et al. Long-Term Results of Extracorporeal Shockwave Treatment for Plantar Fasciitis. The American Journal of Sports Medicine. April 2006. 34: 592-596.

References of Interest

Blue Cross & Blue Shield Association. Technology Evaluation Center: Assessment Program Vol. 19, No. 18, March 2005. Extracorporeal Shock Wave Treatment for Chronic Plantar Fasciitis. Retrieved on 6/6/2007:

How is High Energy ESWT Different from Low Energy or EPAT?

High Energy Extracorporeal Shock Wave Therapy (ESWT) repairs damaged fascia and tendons in one 20 minute treatment. ESWT is an alternative to surgery. Living with chronic plantar fasciitis, Achilles tendonitis, tennis elbow, shoulder or other tendinopathies is not necessary.

Originally all ESWT was high energy ESWT. Over time, manufacturers have started developing or importing cheap machines that are pressure waves or very low energy waves and marketing their treatment as ESWT.

This is confusing to patients because they are very different treatments.

Low energy or pressure waves are physical therapy. Like physical therapy there are numerous treatments scheduled in a series.

Low Energy or pressure wave therapy can be helpful in early stage inflammatory conditions. It is simple physical therapy and not FDA approved.

EPAT and Low Energy Waves are very painful because your tissue is very sensitive and there is no nerve block.

How do they different from the Dornier Epos?

High energy ESWT with the Dornier EPOS is a single treatment REPAIR of the fascia or tendon that replaces invasive, painful surgery. You do not need to suffer chronic tendon or fascia pain.

High energy is a single treatment in 80% of cases. Approximately 20% of patients benefit from a 2nd treatment in about 6 months.

A patient could receive a series of 50 EPAT or low energy wave treatments; and if their tendon needs repair it will do absolutely nothing.

The Dornier Epos is an FDA Class III approved medical device. Only the Dornier Epos Ultra has been proven effective in numerous double blind, randomized placebo controlled studies. FDA Class III is the most difficult approval to achieve.

High energy ESWT with the Dornier Epos Ultra works when other treatments have failed. Including surgery.

High Energy ESWT is administered under a regional nerve block and we are obsessed with your comfort during treatment.

If you are suffering from plantar fasciitis or tendonitis insist on High Energy ESWT with the Dornier Epos.

It’s time to stop the pain.

We will help you.