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).
Tradition Treatment of Carpal Tunnel Syndrome
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.
Pain Mediation Technologies, Inc. has the Answer
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:
- Grip strength increased up to 35%
- Flexion increased up to 12%
- Extension increased up to 20%
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)
- Over 8-million Americans suffer from CTS.
- CTS is the #1 reported medical problem in America, accounting
for over 50% of all work-related injuries.
- 25% of all computer operators have CTS, with NIOSH estimating
that within the next few years over 50% of this entire workforce will
be affected.
- Up to 36% of all CTS patients require unlimited medical treatment.
- Women are twice as likely to develop CTS, as are their male counterparts,
principally due to their higher tendency to retain water (especially
during pregnancy).
- Surgery for CTS is the second most common type of surgery in America.
The U.S. Department of Labor has concluded that CTS is
the "chief occupational hazard of the 21st Century."
- It should be noted that these figures are baseline figures from
1998. With more people becoming computer users (and also at a younger
age), it can be assumed, with certainty, that these numbers are vastly
increased in 2006.
Competition & Competitive Advantages:
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.
Conclusions
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.
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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.
Beth Israel is also testing
a device called Carpal-Ease™, that was developed
by a small start-up in New Jersey to treat wrist pain associated
with carpal tunnel syndrome, wrist arthritis and wrist repetitive
stress syndrome.
The Carpal-Ease™ is a small device worn around
the patient’s wrist, and transmits a low voltage electrical charge
that’s supposed to reduce swelling and pressure on the median nerve.
The desired effects are greater freedom of movement and, more importantly,
less pain for carpal tunnel sufferers.
A small study, the researchers are only recruiting ten patients
for the first phase, and are working with a budget of about $30,000,
which according to Dr. Peter Homel, Director of Biostatistics in
the pain unit, is modest. “For like, major drug studies we’ll get
anywhere from 28 to a couple of hundred patients,” he says in a
telephone interview. And budgets for big drug studies are typically
in the $200,000 to $300,000 range. |
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
(reprinted with permission)
* The pattern of pain scores reported by subject
Fredda Smith is fairly consistent with what was found in the interim
analysis and show that she did show some improvement in least and
average pain after wearing the active device when compared to wearing
the inactive device.
Peter Homel, PhD |
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