Clinical Trial Data
2006 Pilot Study
2002/2003 Study Comparison
2003 Second Phase Study
2002 First Phase Study

2006 Pilot 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 pain.

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 surgery.

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 Syndrome therapy.

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.

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2002/2003 Study Comparison

Subjective Study

  • Long term use.
  • Decreased in pain scale with each subsequent use.
  • Evidence of Therapeutic Value.

Objective Study

  • One time use.
  • Increase in Grip Strength and Flexibility.
  • Evidence of Pain Relief.
Grip Strength increased up to 35%
Wrist Flexion increased up to 12%
Wrist Extention increased up to 20%

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2003 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 use.
    • All Subjects had increased grip strength and increased Wrist Flexion and Extension.


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.

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2002 First Phase Study

                  • 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 use.
                  • All patients recorded the pain level after using the Carpal-Ease™
                  • At the end of the week the pain scale was significantly reduced.
                  • Repetitive use decreased the swelling in the wrist allowing the inflamed tissue to heal.
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.

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