Clinical Trial Data
2006 Pilot Study
2002/2003 Study Comparison
2003 Second Phase Study
2002 First Phase Study
Interim Analysis of Data from the
Current Carpal-Ease™ Trial
Patients were posed questions from a Brief Pain Inventory (BPI) about
least, and average pain for both the past week as well as the amount of
immediate pain they were experiencing. During subsequent weeks, the patient
had either an active Carpal-Ease™ unit or placebo Carpal-Ease™ unit. Baseline
measurements were taken and then follow-up measurements after a week of
wearing the unit.
Figure 1. Least Pain (This measurement
indicates the least or lowest level of pain, experienced during the week.)
Looking at the baseline and at follow-up measurement for 'least pain,'
patients showed a marked and measurable decrease when the active Carpal-Ease™
unit was worn and a substantial increase when the placebo Carpal-Ease™
unit was worn.
Figure 2. Average Pain (This measurement indicates
the average pain experienced during the week) 'Average Pain' shows
a measurable decrease when the active Carpal-Ease™ unit was worn while
an increase was displayed when the placebo Carpal-Ease™ unit was worn.
Figure 3. Pain Right Now (This measurement
indicates how the subject is feeling at the time of filling out the questionnaire.)
'Pain Right Now' shows a marked and substantial decrease (approximate
25%) when the active Carpal-Ease™ unit was worn and an approximate 25%
increase when the placebo Carpal-Ease™ unit was worn.
After using Carpal-Ease™ the participants in the study experienced a reduction
in reported wrist pain. This leads to the conclusion that for the majority
of people suffering from the symptoms of Carpal Tunnel Syndrome, Carpal-Ease™
will provide significant improvement in a relatively short treatment period.
There is a definite positive trend for the active Carpal-Ease™ to decrease
wrist pain with indications of therapeutic rehabilitation with both short
term and long term use; while use of a placebo unit showed increase in
In the past, surgery has been the only viable long-term treatment option
for Carpal Tunnel Syndrome. Despite the risks associated with invasive
surgery, it has only proven effective long-term in less than 60% of cases
where repetitive stress activity is continued. Although symptoms may be
relieved immediately after surgery, full recovery from carpal tunnel surgery
will usually take months of down time and rehabilitation. Some patients
have reported infection, nerve damage, stiffness, and pain at the scar.
Wrists can lose strength long-term, because the carpal ligament is severed.
Patients undergoing surgery often have to change their hand-use pattern
to avoid reoccurrence of CTS symptoms. This may require an adjustment
in job duties or even changing careers altogether after recovery from
Alternative less invasive treatment options, such as Carpal-Ease™, are
urgently needed. Early diagnosis by a trained and licensed professional
combined with proactive treatment to minimize damage and muscle atrophy
is important to prevent the progression of the syndrome. It is also important
for suffers to know that surgery will not be performed and reimbursed
unless the symptoms have progressed to a point where Carpal Tunnel Strain
has become full-on Carpal Tunnel Syndrome documented with nerve conductivity
testing. A general requirement is that severe symptoms must persist for
six months before surgery will be performed. Carpal-Ease™ offers people
suffering from early symptoms of Carpal Tunnel Strain to proactively obtain
relief as soon as symptoms are presented. This allows the patient to take
control of their symptoms with early preventative therapy. It has been
well documented that early treatment of work place injuries is the key
to preventing more severe medical complications as well as sleep disruption
and reduced earnings.
The economics of Carpal Tunnel Syndrome are compelling. It is the biggest
single contributor to lost time at work with workers compensation costs
estimated at over $20 billion per year due to CTS. Medical Insurers would
benefit greatly in reducing the cost of treating carpal tunnel syndrome
through conventional surgery and conservative treatments. It is estimated
that insurers spend over $5 billion per year in conventional Carpal Tunnel
With the cost of Carpal-Ease™ being less than the combined co-pay of a
few visits to a physical therapy clinic, Carpal-Ease™ is a cost effective
alternative to other treatment regimens. We conclude that Carpal-Ease™
provides a reliable, affordable alternative treatment for those who suffer
from chronic Carpal Tunnel Syndrome symptoms due to repetitive stress
injuries. It is especially appealing to those who are determined to be
proactive in preventing the progression of the syndrome to the point where
surgery is an option or even a necessity.
Return to top of page
- Long term use.
- Decreased in pain scale with each subsequent use.
- Evidence of Therapeutic Value.
Grip Strength increased up to 35%
- One time use.
- Increase in Grip Strength and Flexibility.
- Evidence of Pain Relief.
Wrist Flexion increased up to 12%
Wrist Extention increased up to 20%
Return to top of page
Second Phase Study
- Phase two study was done to gather "OBJECTIVE" data.
- Subjects had hand strength and Wrist Flexion and Extension measured.
- The device was worn for one hour.
- Hand strength and Wrist Flexion and Extension were measured post
- All Subjects had increased grip strength and increased Wrist Flexion
Data from second study revealed the following: Grip strength increased
up to 35%; Flexion increased up to 12%; Extension increased up to 20%
. This indicates that along with decreased pain, the subjects are experiencing
increased grip strength along with flexion and extension of the wrist.
Return to top of page
First Phase Study
The study showed a steady decrease in pain as related by the subjects using
the 'Pain Scale Indicator' (where zero indicated no pain and 10 would represent
the worst pain you have ever experienced) over the course of 5 days.
- Initial study was performed over the course of a week
with daily applications of 1 hour.
- Results were tracked using a subjective pain scale.
- All patients experienced reduced pain upon initial
- All patients recorded the pain level after using
- At the end of the week the pain scale was significantly
- Repetitive use decreased the swelling in the wrist
allowing the inflamed tissue to heal.
Return to top of page