CARPAL TUNNEL TREATMENT CLINICAL STUDY RESULTS
At the end of the two weeks, 82% of participants in the study experienced relief from symptoms of Carpal Tunnel Syndrome and a significant improvement in hand functionality as measured by the grip strength testing. One participant did not experience any relief from symptoms and a second experienced only minor relief from the symptoms of Carpal Tunnel Syndrome.
SLEEP INTERRUPTION RESULTS
18% of the patients eliminated sleep interruption due to hand pain after just two weeks of treatment
64% of participants reported significant reduction in the frequency of the interruption of sleep due to hand pain
9% of the participants reported minor improvement, but still experienced sleep interruption
9% of the participants reported no improvement
Sleep interruption is a major issue for Carpal Tunnel Syndrome sufferers. Based on the results of this limited study, we are optimistic that the Carpal Solution will offer Carpal Tunnel Syndrome sufferers relief from the intense pain and interruptions that often occur during sleep.
GRIP STRENGTH RESULTS
Tables 1 though 5 summarize the test data generated with the Jamar Pinch Test and the Jamar Dynamometer 5 Position Grip Strength Device in the attached pages 11 through 15 of EXHIBIT II. Table 5 on page 15 summarizes all of the data for rapid review and comparison.
As demonstrated in EXHIBIT II, areas of improved grip strength varied between position 1, 3, 5 and the pinch test using the Jamar hand functionality testing equipment. This is attributed to the variation of participant’s job functions and hand use patterns leading to soft tissue injury, tendon strain, median nerve impingement and corresponding muscle atrophy. Each patient’s hand muscles are uniquely affected by carpal tunnel syndrome. As the pain is relieved and the patient returns to full activity, the unique hand use pattern also results in custom results for each patient in the restoration of hand grip strength as muscle atrophy is overcome. Also, the different use pattern from the right and left hand in the same patient will result in different improvement rates in the muscle functionality. The size of the individual’s hand and muscle mass are other variables that contribute to the variation in absolute readings from person to person at each of the various positions tested.
As would be expected, the people with the weakest readings experienced the largest percentage improvements. All patients experienced some improvement in at least one of the tests. However, patient number 10 experienced only a 14% improvement in position #1 and no improvement in the other three hand muscle positions tested on the left hand and only minor improvement on the right hand. This patient also did not experience an improvement in symptoms during sleep. It is concluded that the Carpal Solution was not effective for this patient. It seems clear that there are other medical conditions in addition to carpal tunnel syndrome affecting patient number 10. It has been well documented in the literature that many other conditions often complicate the treatment of Carpal Tunnel Syndrome including: diabetes, auto immune disorders such as arthritis, Gout, Hypothyroidism, tenosynovitis of the flexor tendons, ganglion cyst, musculotendinous variants, and various soft tissue tumors, etc. It was beyond the scope of this study to identify other complicating disorders. The Carpal Solution is best suited for relief of CTS symptoms that are brought on by repetitive stress injury.
While physicians often only test one grip strength position to monitor results of therapy due to time constraints, only looking at one position gives limited validation of progress. Patient 10 demonstrates the effectiveness of the test procedure used in this study. In testing multiple hand strength positions, including the pinch test, and by taking the average of three tests at each position, we have a complete look at hand functionality and have avoided potential false positives. The most meaningful data point to focus on is in Table 5 on page 16 of EXHIBIT V, the Average Improvement All Tests for each hand. We will refer to it as the Average Improvement from here on.
In the patients that experienced significant relief from the symptoms of CTS, the Average Improvement results for each hand of each patient ranged from 15.22% Average Improvement in the right hand of patient number 8; to 125.36% Average Improvement in the right hand of patient number 5. Patient 3 had a 97.22% Average Improvement in the right hand while experiencing only an 80.83% Average Improvement in the left hand. This difference is attributed to the difference in use pattern for each hand in the same patient. As the pain of CTS is relieved, the dominant hand will usually respond more quickly to improvement in grip strength testing.
Six patients of the eleven (55%) experienced a greater than 40% Average Improvement in their grip strength in the two week trial. Fourteen, of the eighteen hands treated (78%), experienced a 20% or greater Average Improvement in grip strength. Since the protocol is six weeks for chronic cases of CTS, we would conclude that the patients who were responding more slowly were the more chronic cases. We would expect that as these more chronic cases continue the Carpal Solution therapy, they will experience continued improvement in grip strength and eventually eliminate the interruption of sleep due to hand pain.