over 50 million Americans are treated for pain resulting from wounds
or surgery, joint and muscle injuries, or arthritis. As Americas
baby boomers age and begin to suffer from chronic illnesses, they
will be seeking better ways to effectively manage pain.
management method, ancient and well-established but not commonly
used, is transcutaneous electrical nerve stimulation, or TENS. In
this method, low-level electrical pulses are delivered through the
skin to inhibit or interfere with the transmission of pain signals
to the brain.
problem with the method is that it has been too expensive and difficult
to use. But thats about to change, because a team of Livermore,
private-industry, and Russian scientists has developed a device
that turns TENS into a viable treatment process. For their work,
the team has been awarded an R&D 100 Award.
||Some Livermore members of
the team that developed STIM-2002 TENS. From left,
Bill Colston (demonstrating one way of applying the STIM-2002
TENS device), Alexander Rubenchik, and John Marion. Not pictured
are Kenneth Michlitsch,
Luiz Da Silva, and Ted Saito.
In 1965, Canadian psychologist Ronald Melzack
and British physiologist Patrick Wall performed an in-depth study
of pain transmission and published a now-famous theory that spawned
the development of TENS devices. Their study and those of others
revealed that in 25 years of use, TENS had caused no serious side
effects or injuries. In fact, these studies and the sustained sales
of TENS devices during the study period validated TENS as an effective
and safe pain-relieving alternative.
Traditionally, TENS devices
have been prescribed for managing intense, intractable chronic pain.
They are also routinely used in conjunction with other therapies
during physical rehabilitation to maximize pain relief and increase
patient tolerance for exercise and movement.
But standard TENS devices
have been largely inappropriate for short-term, acute pain management
because they have been large, complex, and expensive and have required
operation by a licensed therapist or physician. If TENS were easier
to use and less expensive, it could supplant narcotics and other
common medical prescriptions for pain.
|The wireless STIM-2002 TENS
receiverstimulator can be applied to different parts of
a patients body. It is remote-controlled by a palm-sized
That has now happened. Lawrence
Livermore, Cyclotec Advanced Medical Technologies (Cyclotec), Inc.,
and the Biophysical Laboratory (Biofil) Ltd. of Sarov, Russia, working
under the Department of Energy Initiatives for Proliferation Prevention
Program, have formed a joint cooperative research agreement to develop
an advanced, easy-to-use TENS technology, currently known as STIM-2002
Jeffrey S. Mannheimer and
Stephen A. Michaelson of Cyclotec developed the initial concept
and clinical methodologies for the product based on commercial market
needs. Livermore scientists Bill W. Colston, Jr., Kenneth J. Michlitsch,
Luiz B. Da Silva, Alexander Rubenchik, Ted Saito, and John E. Marion
partnered with Cyclotec and Biofil to develop and miniaturize a
smart controller for the improved TENS device. Russian scientists
from Biofil, working with Cyclotec, completed the mechanical and
electrical packaging and construction of the device.
The STIM-2002 TENS device
consists of two miniature electronic modules. One is a remote-controlled,
preprogrammed transmitter that can be kept in the users pocket
or worn like a pendant around the neck. The other is a stimulatorreceiver
that is positioned on top of a conductive adhesive electrode that
attaches the device to the patient. The transmitter sends the stimulation
paradigm to the receiver, which produces the pain-relieving pulses
where the module has been applied. Because the receiver is integrated
with and mounted on the electrode, lead wireswhich encumber
other commercial pulse stimulatorsare unnecessary.
To use the device, a patient
simply puts it on like a bandage. The electrodes can be easily reconfigured
for different body applications (to the arm, wrist, knee, back,
neck, or a small wound). Using the three buttons on the transmitter,
a patient can select one of six stimulation treatment modes (depending
on the pain and the desired therapy), different intensities of stimulation,
and different cycling protocols (that is, cycling through selected
stimulation modes for a desired treatment). The fingertip programming
that the user performs is similar to changing the settings on a
digital wristwatch and is much simpler than programming a VCR. In
fact, the operation of this TENS is intuitive; it can be used safely
and effectively without professional guidance.
The device provides patients
with feedback on operational status by continuously displaying current
mode, elapsed time, and intensity. It also collects usage data that
physicians can download if they so desire.
With its small size (as much
as five times smaller than other TENS), wirelessness, ease of use,
and cost effectiveness, the STIM-2002 TENS certainly gives patients
greater flexibility, comfort, and rapid pain relief.
psychiatrists, and physical therapists believe STIM-2002 TENS to
be a significant breakthrough because it allows TENS to be used
outside the doctors office. The U.S. National Institute on
Drug Abuse, which supported the development of STIM-2002 TENS through
grants to Cyclotec, recommends this TENS medical instrument because
it offers pain sufferers with a viable alternative to drugs
for pain relief and allows them to avoid drug side effects,
abuse, or dependency.
In a range of usesfrom
treatment of minor cuts, burns, scratches, and wounds where regular
bandages are applied, to alleviating the pain of minor surgical
procedures such as suturing, to providing relief after arthroscopic
surgeryTENS offers faster, more precisely directed relief
than oral and even some injected drugs. It has not caused any serious
and does not have anesthetic, narcotic, or addictive effects. Furthermore,
TENS treatment can be stopped instantaneously, without waiting for
the body to eliminate accumulated drugs.
the future, the technology development team sees STIM-2002 TENS
products configured as dynamic splints,
braces, supports, and straps. They envision remote-controlled TENS
transmitters in wristwatch form. They are completing
an even smaller electronic Band-Aid that can protect
open wounds, control pain, and enhance circulation to promote healing.
the STIM-2002 TENS device will significantly improve the quality
of life for millions of Americans. Users will have greater control
and management of their pain so that their work and activities will
not be affected or interrupted. And health professionalsincluding
physical therapists, physical rehabilitation physicians, chiropractors,
occupational therapists, and medical clinicianswill find that
this device significantly augments and benefits their work.
Key Words: electronic
adhesive bandage, medical device, pain management, R&D 100 Award,
transcutaneous electrical nerve stimulation (TENS).
For further information contact John Marion (925) 423-6788 (firstname.lastname@example.org).