Carpal-Ease

Pain Mediation Technologies Seeks FDA 510K Approval for its Carpal-Ease™ Device

Matthew Gitkin
Vice President – Public Relations & Media
Release: December 2006

Low Flux Density Static Electro Magnetic Fields (SEMFs) could have a substantial impact on different medical ailments ranging from Carpal Tunnel syndrome to Patellar Tendonitis to Supraspinatus Tendonitis. However, few companies have successfully obtained Food and Drug Administration (“FDA”) approval to commercialize SEMF materials and devices. This article, introduces Pain Mediation Technologies, a company seeking to obtain FDA approval for a SEMF medical “device,” and how it plans to capitalize on this achievement, with the introduction of its first product for wrist pain; Carpal-Ease™.

Introduction; What is Carpal Tunnel Syndrome?

Carpal Tunnel Syndrome (CTS) is a compression neuropathy of the median nerve within the carpal tunnel which is the channel on the palm side of the wrist formed on the side by the semi-circular arrangement of the bones of the wrist and on the other by the carpal ligament. Running through the tunnel are the tendons used to move the fingers and wrist and the median nerve, which is one of two nerves providing both sensation and motor function in the hand.

The structure of the carpal tunnel leaves very little room for expansion so swelling of the tissue in or around the carpal tunnel can press on the median nerve and cause the symptoms of carpal tunnel syndrome. Symptoms include aching, tingling, pins and needles, burning, numbness, or pain in the hand and in the digits served by the median nerve – the thumb, the index and middle fingers, and part of the ring finger. In time, symptoms can spread to the arm and shoulder. It affects about 1 in 100 people at some point in their life. Men and women of any age can develop it, but it is most common in women ages 30 to 60.

These symptoms tend to be worse at night or first thing in the morning and are often aggravated by strenuous wrist movements. Carpal tunnel syndrome can affect one or both hands, and the severity of the symptoms can vary. The symptoms may be mild or only occur from time to time. As the condition worsens, symptoms may become constant. The hand muscles may become weakened, making it difficult to grip objects, and there may be permanent loss of feeling. Fine finger movements, such as writing, may become more difficult.

The term repetitive stress injury (RSI) refers to a group of conditions caused by placing too much stress on a joint. CTS is included in the category of RSIs. Repetitive stress injury happens when the same action is performed repeatedly. When stress is placed on a joint it pulls on the tissues around it. These tissues include muscles, tendons and bursae. This can cause pain and swelling in the muscles, tendons and bursae. When an action that is stressful to a joint is repeated frequently, such as when playing tennis or typing, the area does not have time to recover and it becomes irritated. This can cause the area to become painful and swollen. The two most common types of repetitive stress injury are tendonitis and bursitis. Tendonitis is inflammation of a tendon. Bursitis is inflammation of a bursa.

RSIs generally occur in those over the age of 30 as a result of the normal wear and tear of aging. The incidence of RSI is becoming more widespread as many jobs now require people to make repetitive actions such as typing or clicking a computer mouse. It can also occur more frequently in those who play sports. DeQuervain's tendosynovitis is caused by repeated pinching or twisting of the wrist.

NIOSH (National Institute for Occupational Safety and Health) reports that over 8 million American suffer from CTS with 850,000 new cases annually. CTS accounts for over 50 % of all work-related injuries. The prevalence is high among computer operators, with 25 % of all computer operators currently showing some degree of CTS. Up to 36 % of all CTS patients require unlimited medical treatment and 30 % of the new cases presenting each year will require surgery (NIOSH 137-140).

Non-surgical treatments include corticosteroid tablets (e.g. prednisolone), steroid injections (e.g. hydrocortisone) given directly into the carpal tunnel, and prescription-only NSAIDs, such as diclofenac (e.g. Voltarol) and celecoxib (Celebrex). These help to reduce swelling and give some temporary relief. If excess fluid is thought to be causing the swelling, a doctor may prescribe a diuretic drug that causes the body to excrete more water and reduce fluid pressure. Other treatments include ultrasound treatment and vitamin B6 (pyridoxine) tablets although there is little evidence to suggest they are effective. There is some literature supporting laser acupuncture for reducing pain.

If the symptoms worsen, and the cause of the carpal tunnel syndrome can’t be removed, surgery is often the only effective longterm treatment. The operation known as carpal tunnel release involves cutting the carpal ligament to make more space for the nerves and tendons in the carpal tunnel. It can usually be done as an outpatient procedure. In a more traditional, open operation, a long cut is made in the palm of the hand. More recently, the operation may be done endoscopically which leaves a smaller scar, and usually allows people to get back to their usual activities more quickly. However, there may be a slightly higher risk of nerve damage with the endoscopic repair.

Similar to CTS, the most common medications for RSIs are NSAIDS and corticosteroids. NSAIDS are used to treat the inflammation of repetitive stress injury. NSAIDs reduce pain when taken at a low dose, and relieve inflammation when taken at a higher dose.

A corticosteroid, like prednisone, may also be prescribed to reduce the inflammation. Some of the side effects from long-term use of prednisone include cataracts, high blood pressure, sleep problems, muscle loss, bruising, thinning of the bones (osteoporosis), weight gain and increased risk of infections. The goal with this and most drugs is to find the lowest effective dose that will avoid as many of the side effects as possible.

Cold application can also provide temporary relief of the pain of repetitive stress injury. Cold helps numb the area by constricting the blood vessels and blocking nerve impulses in the joint. This in turn helps to reduce the inflammation.

After the irritation and swelling of the joint has been reduced, patients with RSI are urged to begin to begin exercising the muscles slowly so they do not become irritated again and to prevent loss of movement in the joint.

Dr. Robert Sylvester and his colleagues at Pain Mediation Technologies hope to change that with Carpal-Ease™, by using Low Flux Density SEMF Technology for relief of pain and the therapeutic treatment of inflammatory and painful disorders of the hand and wrist.

Carpal-Ease’s™ Low Flux Density SEMF Technology works by slightly changing the charges associated with voltage-dependant ion channels in the cell membranes of the human body. This stabilizes abnormal fluid transport into the cells through aquaporin channels and the sodium ions relating to them: treating inflammation; and altering the flow of calcium, chloride and potassium ions through their respective neuronal ion channels: thus treating pain.

In the initial trials conducted by PMT, test subjects receiving a onetime application of the Carpal-Ease’s™ device lasting from 45 to 60 minutes, showed the following results when grip strength, wrist flexion and wrist extension were tested immediately before and after application:

The details of the process used to create Low Flux Density SEMF Technology are currently a trade secret. The result, however, is that when the Low Flux Density SEMF Technology of the invention is introduced to a region of the body experiencing pain it effectively reduces pain.

According to the U.S. Bureau of Labor Statistics, nearly two thirds of repetitive strain injuries were caused by exposure to repeated trauma of the wrist, elbow or shoulder. This repetitious trauma, according to the National Center for Health Statistics, is what produces CTS, with over 850,000 new cases annually, 260,000 eventually requiring carpal tunnel release surgery. NIOSH has published the following results from its statistical data base. (http://www.cdc.gov/niosh/homepage)

The U.S. Department of Labor has concluded that CTS is the "chief occupational hazard of the 21st Century."

Non-medical products to manage CTS pain are strictly confined to: massagers, pain gels, hot & cold packs, exercise equipment, braces and magnets. Most of these products are priced in the tens-of-dollars, with more elaborate braces, and magnets, in the hundreds. Currently, there are not any products available that employ any modern technologies.

Static Electro Magnetic Field (SEMF) treatment technology could have a substantial impact on medicine in general, with direct effects for relief of pain and the therapeutic treatment of inflammatory and painful disorders. Pending FDA approval, Pain Mediation Technologies, Inc. will provide the first example of a company to successfully bring a Static Electro Magnetic Field (SEMF) medical device to market. Focus, strategic thinking and an experienced management team will provide PMT's first-to-market advantage with an innovative technology.

Your Body for Science: Clinical trials are not just for guinea pigs.

Our Town downtown | January 15, 2007

Edward Gallardo’s troubles began about ten years ago. Since then, the actor, playwright and Chelsea resident has been through prostate cancer-related surgery, multiple back surgeries and complications from both.

“This last one was for lumbar fusion. It’s been fun,” he says with a laugh, in the Hollywood Diner, across the street from his apartment.

A look at a dated photo on his Web site makes it clear that Gallardo, who says he was healthy prior to his prostate and back ailments, is a shadow of his former self. He moves the way he talks, with a lot of effort, and gets around with the aid of a cane. He can walk about two blocks, tops. Yet harsh as that may sound, he is feeling much better these days and credits his participation in one of the many clinical trials that take place at downtown research centers, with making him feel better than he has in a long time.

Gallardo has not worked in years due to severe pain, and has been on morphine since about 2004. His regimen includes one long-lasting pill, three times a day, and another short-lasting, but more potent pill, every four hours as needed.

The morphine helps, but for a long time, it had a nasty side effect, narcolepsy. He would fall asleep abruptly, without warning, even while standing, up to what he estimates was 12 times a day. This was particularly dangerous because he is a smoker. “[I] have woken up and the cigarette’s on the floor … in my apartment … more than once.” He was also afraid of passing out in the street or in another public place.

He complained about the problem to his doctor at Beth Israel Medical Center, who told him he would be a good candidate for a drug trial being conducted at the hospital’s Pain Medicine and Palliative Care unit.

The drug was Modafinil, a stimulant normally prescribed for sleep disorders. The aim of the study was to see how effective it was in treating sedation and excessive daytime sleepiness in patients on pain medications. Gallardo took it every morning for four weeks, and filled out a daily sleep chart to measure how long and how soundly he slept, when he wanted to sleep, and how many times he fell asleep when he didn’t want to.

Gallardo says the results were “astounding,” and that he knew it wasn’t a placebo within two hours of taking it for the first time. “The only time I fell out would be like when I was watching a DVD or something … And that would be, I’m sure, because I don’t sleep well.” Otherwise, he had more energy than he had had since he began taking morphine two years ago. He could walk more too.

Throughout the trial process the researchers were available to answer any questions he had and he describes the experience as “wonderful.”

The researchers told him about all the possible side effects, but he “felt very safe taking it.” And the only thing that scared him was what would happen when the study ended, since he received the medication for free while he participated.

The study ended on January 5th, and now Gallardo is trying to convince his insurance company to pay for the drug. He says he expects they will.

Not all trials are as invasive as those that involve taking a new drug or undergoing experimental surgery.

A lot of the studies at the pain center involve opiates. Some come from drug companies who ask researchers at anywhere from five to twenty sites to test new products.

And others are “investigator-initiated,” where doctors at the center take existing opiates like morphine or oxycodone, for example, and test out how well they work when they’re applied in new ways, or test out new formulations they’ve come up with on their own. Typically, drug companies or the National Institutes of Health (NIH) are approached for the funding of investigator-initiated studies.

Study participants, like Edward Gallardo, are often existing patients, recruited through other parts of the hospital or its network, for trials that apply to a specific condition they have. But investigators also launch aggressive campaigns that utilize the media and the Internet. (An advertisement for the carpal tunnel study was posted on Craig’s List.) NYU Medical Center advertises its studies in newspapers, on the radio, on its Web site and on television. There are even ads on buses to get subjects to come in and participate in trials.

For some studies, outreach workers go into the field and recruit people cold. Project ACHIEVE (AIDS Community Health Initiative Enroute to a Vaccine Effort), a part of the HIV Vaccine Trials Network, is holding HIV vaccine trials at its Union Square location. The group’s outreach workers recruit men off the streets of Chelsea, and in gay bars and clubs to participate in clinical trials.

Beth Israel’s Dr. Peter Homel says that that the number of institutions conducting research and the number of individual trials is very high, so the competition between them to get volunteers is intense, and “people are practically inundated by ads.”

For the carpal tunnel study, he put up flyers in departments that would deal with the syndrome – neurology and the pain clinic were a few – and even put them up in local health food stores. Fredda Smith saw one in the Sol Goldman 14th Street Y, where she volunteers, and signed up for the study.

Smith, who has carpal tunnel syndrome in both wrists, didn’t realize until after two preliminary interviews that she would be paid for taking part. From that point on she received fifty dollars for each session. *

Typically research volunteers are compensated. “You’re asking for them to come in and give up their time … It interferes with their life, their work. It’s travel costs, all those sorts of things,” Homel says.

Beau Gostomsky, who directs clinical trials at NYU Medical Center, says that in the majority of studies research institutions pay volunteers for their travel expenses, and a small stipend if they’re going to have to stay for an hour or two.

If it’s a long-term study where the subject has to stay overnight and undergo lab tests, he or she
is usually paid per-hour, “based on time and effort,” he says in a telephone interview.

But Gostomsky stresses that despite popular notions about professional guinea pigs, the incentive to participate in a medical trial should not be money. He says that people do approach him with money on the brain, though. “We have to be very diligent … from an institutional standpoint to make sure that compensation doesn’t appear as an incentive or is not an incentive, or isn’t a coercive incentive.” And his concern about this goes well beyond his own institution. “The federal government is very concerned that a study doesn’t come through and [say] ‘listen, if you participate, we’re gonna pay you $10,000’ … That would unduly influence somebody to participate in a clinical trial.” For this reason, he says, compensation is “minimal” and should only cover “time and effort.”

Potential benefits aside, some people are hesitant to volunteer for medical research for fear of side effects. Federal law mandates that all potential side effects of a particular drug are made clear in the informed consent documents a patient signs before they take part in a study.
But Gostomsky says that the informed consent process is not just signing off on an initial waiver form and hoping for the best. And if it was, it’s not now. Informed consent is an ongoing, active process, a dialogue between the subject, the investigator and the research team, he says.
“It’s very much focused on, you know, continually informing the patient and continually encouraging the patient as to whether or not they want to be, and continue in, the trial. A patient can withdraw from a clinical trial at any time for any reason.”

And there is an institutional review board in place at most hospitals to safeguard the rights of patients, and ensure that all clinical trials are ethical.

Any clinical trial in the U.S. must gain approval from an institutional review board before it begins. According to the NIH, these boards consist of doctors, statisticians, researchers, and community advocates among others, and periodically review ongoing research after it’s approved.

A.J. Walker had heard rumors about HIV vaccine tests, but had no idea he’d end up participating in clinical trials for one. Walker, 27, lives in Chelsea and is a writer.
He was at Splash, a gay bar on 17th Street, when he was approached by a member of Project ACHIEVE’s outreach team who was looking for men of color who have sex with men. He was interested, but for a reason he can’t recall, wasn’t applicable for that particular study. But he volunteered for another one the outreach team suggested. “They interviewed me and asked me a ton of questions, which fortunately for me, I consider myself an open book, so that wasn’t a big problem,” he says in a telephone interview.

He entered the first part of the study last spring and went in for vaccinations once every two weeks at first. Now that he’s in the later stages of the study, he goes in every six months. His last visit was in August.

Walker never had any reservations about participating, although he admits that he has “friends who were very sort of neurotic, like ‘oh my God, you’re gonna take a risk. They’re gonna infect your blood’ and everything like that.” His thinking was that, having worked with HIV positive populations in the past, having done research on the virus, and considering all the modern safeguards for patients, there was “no way on earth that anything would be allowed to be operated in this day and age that had more than perhaps a tenth of a percent of risk of me being infected [with] HIV.”

He says he could only see good coming out of participating, and while he is “99.9 percent safe,” in terms of sexual activity, being a part of the study is helping him to analyze his own sexual behaviors more effectively. “It causes you to really reevaluate the situations that you’ve been in and how safe you’ve been, and how safe you could be.”

The Union Square site is one of three locations where Project ACHIEVE conducts HIV vaccine studies. The other two are at Columbia University Medical Center and in the Bronx.
The HIV Vaccine Trials Network is international and its headquarters are in Seattle.

Project ACHIEVE is in the middle of a phase II trial and currently has the highest enrollment for the trial in the country, according to John Bonelli, who supervises the recruiters and organizes outreach activities for the group.

Krista Goodman, who oversees clinic operations, describes the different stages of research, in a telephone interview. “Phase I trials are the first step of human experimental testing, which is really determining the safety of the vaccine.” Over the years they’ve conducted about 15 at the Union Square site.

“If they seem to be safe … and there’s some sort of immune response, it can move into a phase II trial.” Phase II looks at a vaccine’s effectiveness. Specified populations take the vaccine, with their likelihood of contracting HIV taken into account.

They are compared with a control group (that doesn’t get the vaccine), and if the results are promising the study can move into phase III trials. “This is really looking at efficacy, and does this vaccine work.”

Goodman says only one phase III trial has ever taken place in the United States and that the results were disappointing. “There was absolutely no difference between people who got the vaccine and people who didn’t, and the number of infections that occurred.” She estimates that it ended in 2003.

The current phase II trial is promising, “anecdotally,” but she says none of the data’s been analyzed.

Goodman and Bonelli agree that the most realistic answer to the AIDS riddle is probably a vaccine, rather than a cure, largely because of economics; though more and more medications are being developed to help people with AIDS live longer, the majority of people worldwide cannot afford them, and a cure will likely be very costly. “It’s really about preventing new infections. I think that’s where the push is,” Goodman says.

Studies like the ones the network are conducting take a long time to complete and analyze. Goodman says individual studies take four to five years to conduct, so it’s not possible to imagine when a working vaccine will be discovered. To illustrate this she mentions that the data from some of the ongoing studies were projected to be available in 2011.

The importance of studies like these, Bonelli says, is that even though findings from each one are pieces of a much larger puzzle, the science keeps advancing with each small discovery.
Speaking about the project’s work in cooperation with other network members around the globe, A.J. Walker says he thinks the project is “a case of building blocks.”

And asked whether he would have been as quick to take part in a clinical trial, before he got sick, Edward Gallardo (who took part in the pain medication study) says that if there were something he felt were important enough – he happens to mention a hypothetical AIDS vaccine – he “definitely” would have.

Recently, he read about a doctor who built a bladder out of stem cells and was intrigued, since
complications from prostate cancer have left him incontinent. He says that if he could find a clinical trial for it, he “would do it in a nanosecond.”

-- Matt Elzweig