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  • 1. STS TREATMENTS REVERSE NERVE CONDUCTION LOSS AND LOSS OF PROTECTIVE SENSATION IN PATIENTS WITH DIABETES TYPE 2 Deborah Carver, M.D. (1) Jose Gaurdiola, Ph.D. (2) Marian Hendricks, D.O. (3) Donald Rhodes, D.P.M., F.A.C.F.A.S. (4) Glenda Sue Roefer, D.O., C.D.E. (5) (1) Neurology Clinic of Central Texas, New Braunfels, Texas (2) Texas A&M University Corpus Christi, Department of Computing and Mathematical Sciences, Corpus Christi, Texas (3) Coastal Bend Chronic Pain Center, Corpus Christi, Texas (4) Coastal Bend Chronic Pain Center, Corpus Christi, Texas (5) Thomas Spann Clinic, Corpus Christi, Texas ABSTRACT OBJECTIVE— To determine if Sympathetic Therapy System treatment can reverse Loss of Protective Sensation (LOPS), reverse decreased nerve conduction, and decrease subjective neuropathy symptoms in patients with diabetes mellitus type 2. RESEARCH DESIGN AND METHODS—19 patients suffering from diabetes type 2 received sympathetic therapy system treatments (Dynatron STS, Dynatronics Corporation, Salt Lake City, Utah). Sympathetic therapy is designed to stimulate the production of neuropeptides utilizing electric current. Twelve men and seven women, ranging in age from 25 to 88 years old, with an average age of 54 years old were treated utilizing twice daily treatments for one month followed by once daily treatments for the duration of the six month study. Each participant filled in questionnaires, while in the clinic, and rated their symptoms on a VAS scale of 0 to10. Nerve conduction velocity studies (NCV) and Vibration Perception Threshold testing (VPT) were performed prior to the study, at 90 and 180 days. In addition, the VPT testing was also performed at 30 and 60 days. RESULTS—Both Vibration Perception Threshold (VPT) and Nerve Conduction Velocity (NCV) showed statistically significant improvement. In addition, the participants’ rating of their symptoms mirrored the objective testing. NCV studies showed an overall improvement of 43% at 90 days and 47% improvement at 180 days. NCV studies showed that 23% of the nonresponsive nerves became responsive by day 180. Specifically, 3% of the nonresponsive sural nerves and 42% of the nonresponsive peroneal nerves became responsive. NCV testing showed that 47% of the nerves tested had improvement by 180 days. This included 40% of the sural nerves and 53% of the peroneal nerves. At the beginning of the study, 11% of the 190 sites tested had a normal
  • 2. 2 VPT testing. At 180 days, 44% of the 190 sites tested had a normal VPT testing. At the beginning of the study VPT testing showed that 73% of the 190 sites had a LOPS (Loss of Protective Sensation). At day 180, VPT testing showed that only 39% of the 190 sites tested had LOPS. In addition, at day 180, VPT testing showed that 91% of the 190 sites had improved, compared to the beginning of the study. Analysis showed that there was a statistically significant improvement in the VPT results even after only one month of treatment (p <.001, Friedman test). This statistical improvement remained throughout the six-month study. The participants reported moderate to severe foot and ankle symptoms including pain, tingling, and numbness before the study. However, these symptoms were reported as markedly improved within month one of treatment. CONCLUSIONS—STS therapy effectively improved VPT (LOPS) and NCV deficits, as well as, the subjective neuropathic symptoms in the patients with diabetes type 2 seen in this pilot study. This pilot study demonstrates the need for follow up studies involving more patients and sham treatments for better evaluation of this methodology. INTRODUCTION According to the American Diabetes Association, there are over 20.8 million children and adults in the United States, or approximately 7% of the population, who have diabetes. In addition, the U.S. spends over $132 billion a year on diabetes -- $13,242 on each patient with diabetes, compared with $2,560 per person for people who do not have diabetes -- measured in the direct and indirect costs of emergency room visits, expensive and extended hospitalizations, disability insurance costs, absenteeism and lost worker productivity. In addition, more than 5.5 million Americans have been diagnosed with diabetic peripheral neuropathies. This process is progressive and can lead to increased risk of injury, infection, Charcot joints, and amputation. South Texas, with its high Hispanic population has a very high incidence of amputations. Diabetic peripheral neuropathy is a common complication associated with diabetes. It increases with both age and duration of diabetes, and is present in more than 50% of Type 2 diabetic patients aged over 60 years. (1) Testing for diabetic peripheral neuropathies is recommended on a regular basis such as monofilament testing at office visits. Routine neurological examinations such as light touch and pinprick sensation, though commonly used to test for neuropathies, have been found to be less sensitive to diagnose diabetic neuropathy than Vibration Perception Threshold testing (VPT). A recent study of diabetic type 2 patients showed that the VPT was elevated in 65% of the patients with sensory complaints but also in 20% of the patients without sensory complaints. (2) In the past, there have not been effective treatments for this disease process, and the largely unsatisfactory results reported for the pharmacological treatment of diabetic neuropathy has spurred the search for alternative therapies. (3)
  • 3. 3 In 2003, the long-term complications of diabetic peripheral neuropathy experienced by 2.4 million people in the U.S. with reduced vibration detection were estimated to cost all U.S. health care payers approximately $14.7 billion over the next 10 years. (4) Peripheral neuropathy (or diabetic polyneuropathy) can present as a loss of sensation that can lead to neuropathic ulcers, and it is a leading cause of amputation. (5)(6) It has been found that compliance with a preventative foot care program reduces the incidence of foot ulceration in individuals with reduced vibration detection. (7) In addition, identification and treatment of individuals with reduced vibration detection that resulted in improved or normalized vibration perception would reduce the risk of ulceration and amputation. This could save up to $11.8 billion and save 333,000 life- years over the next 10 years. (8) The treatment of diabetic foot ulcerations and amputation is time-consuming and expensive. Treatment aimed at improving peripheral neuropathy, reversing or preventing loss of protective sensation (LOPS), and avoidance of ulcerations and amputations could potentially save valuable resources and improve health outcomes. (9) In a study published in 2002, treatments utilizing the Dynatronic STS system were shown to successfully decrease the objective signs and subjective symptoms of peripheral neuropathy patients. During that study, daily skin temperatures were obtained from the palmar surface of the thumbs and the plantar surface of the bilateral hallux. The study demonstrated that there was a partial or complete normalization of the actual skin temperature and the skin temperature gradient, left to right. Two patients in that study had diabetes, and both of these patients had improvement in nerve conduction velocity by the end of one month of hourly STS treatments. (10) Interestingly since then, two different studies have shown that, if elevated temperature differences between contralateral sites can be kept below 4 degrees Fahrenheit, plantar ulcerations in diabetic feet can be markedly reduced. Although this was not specifically addressed in this particular study, it will be addressed in an upcoming study to show that this treatment will cause normalization of temperature differences and decreased LOPS. (11)(12) RESEARCH DESIGN AND METHODS This investigation employed a single-case experimental design. The subjects received the treatment and would, therefore, be considered a single group or a time-series design (13) Study participants were recruited from the South Texas area. This study was comprised of 19 patients with Diabetes Mellitus type 2. Patients with pacemakers (due to the contraindication for electrical stimulation) or amputated limbs (due to the treatment requiring all four extremities to attach electrodes) were excluded from this study. During each visit to the clinic, the patients filled in questionnaires and rated their symptoms on a visual analog scale (VAS) of 0 to10. Nerve conduction velocity studies (NCV) and Vibration Perception Threshold testing (VPT) were
  • 4. 4 performed prior to the study, at 90 and 180 days. In addition, the VPT testing was performed at 30 and 60 days. Five different sites of each foot were tested for VPT. These included the plantar aspect of the head of the hallux proximal phalanx head, the plantar aspect of the 1st and 5th metatarsal heads, the medial malleolus, and the lateral malleolus. Nerve conduction velocity studies were performed on the sural and peroneal nerves, bilaterally. The patients were evaluated and received STS treatments every day in the clinic for the first thirty days and once per week thereafter for 180 days. In addition, the participants administered STS treatments to themselves at home each evening after 7 P.M. When the patients were seen in the clinic, their unit’s hour meter was checked to insure that the patient had utilized the unit for the previous night or week’s treatments. STS treatments are two simultaneous interferential treatments at a low carrier frequency, which allows longer beat duration than standard interferential treatments. The electrode leads are color-coded with the red and white leads utilizing an 1850 Hertz carrier frequency, with the yellow and black leads utilizing a 2850 Hertz carrier frequency. In this study, the beat frequency of both pairs was set to ramp up and down between 8 and 12 beats per second. The treatment was administered utilizing 8 TENS-type self-adherent electrodes. All of the electrodes utilized for the lower body treatments were “Optimizer” electrodes (magnetic electrodes from Alan Neuromedical Technologies) while only the red and white electrodes utilized for the upper body utilized the “Optimizer” electrodes. Patients completed pain grids, while in the clinic, depicting the area of worst pain, and secondary areas of pain. The electrode pad placement protocols were selected on the basis of the location of the worst pain of that day. If the patient had no area(s) of pain, a generalized upper and/or lower body STS protocol was administered, which had been designed for diabetes. All of these protocols were based upon acupuncture points, dermatomes, thermatomes, and nerve roots. Each treatment included forty minutes of treatment given through the lower extremities and forty minutes of treatment given through the upper extremities. Only 17 of the participants received NCV testing at day 0 and 180. One of those participants did not receive NCV testing at day 90. All 19 participants received VPT testing at day 0, 30, 60, 90, and 180.
  • 5. 5 RESULTS Percentage of Patient Testing Sites with Normal VPT compared to Abnormal VPT (Markedly increased risk of amputation) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Normal (<15) Day 0 Abnormal (>25) Normal (<15) Day 180 Abnormal (>25) Percentage of nerve sites with normal VPT (<15V.) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Day 0 Day 30 Day 60 Day 180
  • 6. 6 TABLE 1 NCV RESULTS Distal Motor Latency Motor NCV AMP. CMAP normal <= 5.8 m/sec normal > 43 m/sec normal > 2.3 Right Peroneal Nerve Right Peroneal Nerve Right Peroneal Nerve Day 0 Day 90 Day 180 Day 0 Day 90 Day 180 Day 0 Day 90 Day 180 Nonresponsive 4/17=24% 1/16=6% 1/17=6% 4/17=24% 1/16=6% 2/17=12% 4/17=24% 1/16=6% 2/17=12% IMPROVED 0- 90 DAYS 7/16 =44% 11/16=69% 11/16=69% IMPROVED 0-180 DAYS 9/17= 53% 10/17=59% 9/17=53% Nonresponsive to Responsive 75% 75% 75% 50% 75% 50% Distal Sensory Latency Sensory NCV AMP. SNAP normal < 3.2 m/sec normal > 40 m/sec normal > 10 Right Sural Nerve Right Sural Nerve Right Sural Nerve Day 0 Day 90 Day 180 Day 0 Day 90 Day 180 Day 0 Day 90 Day 180 Nonresponsive 7/17=41% 8/16=50% 7/17=41% 7/17=41% 8/16=47% 7/17=41% 7/17=41% 8/16=50% 7/17=41% IMPROVED 0- 90 DAYS 5/16=31% 3/16=19% 7/16=44% IMPROVED 0-180 DAYS 6/17=35% 5/17 = 29% 8/17=47% Nonresponsive to Responsive <6%> 0% <6%> 0% <6%> 0% Distal Motor Latency Motor NCV AMP. CMAP normal < 5.8 m/sec normal > 43 m/sec normal > 2.3 Left Peroneal Nerve Left Peroneal Nerve Left Peroneal Nerve Day 0 Day 90 Day 180 Day 0 Day 90 Day 180 Day 0 Day 90 Day 180 Nonresponsive 4/17=24% 2/16=13% 3/17=18% 4/17=24% 2/16=13% 3/17=18% 4/17=24% 2/16=13% 3/17=18% IMPROVED 0- 90 DAYS 6/16=38% 8/16=50% 10/16=63% IMPROVED 0-180 DAYS 6/17=35% 10/17=62% 9/17=53% Nonresponsive to Responsive 50% 25% 50% 25% 50% 25% Distal Sensory Latency Sensory NCV AMP. SNAP normal < 3.2 normal > 40 m/sec normal > 10 Left Sural Nerve Left Sural Nerve Left Sural Nerve Day 0 Day 90 Day 180 Day 0 Day 90 Day 180 Day 0 Day 90 Day 180 Nonresponsive 7/17=41% 8/16=50% 6/17=35% 7/17=41% 8/16=50% 6/17=35% 7/17=41% 8/16=50% 6/17=35% IMPROVED 0- 90 DAYS 3/16=19% 4/16=25% 7/16=44% IMPROVED 0-180 DAYS 6/17=35% 8/17=47% 8/17=47% Nonresponsive to Responsive <6%> 6% <6%> 6% <6%> 6% Nerve Conduction Velocity Studies
  • 7. 7 0 to 90 days Nonresponsive to Responsive Nerves Sural <6%> Peroneal 63% Overall 29% Improved NCV Sural 30% Peroneal 56% Overall 43% 0 to 180 days Nonresponsive to Responsive Sural 3% Peroneal 42% Overall 23% Improved NCV Sural 40% Peroneal 53% Overall 47% TABLE 2
  • 8. 8 VPT Improvement Day 0 to Day 180 0-15 16-25 26-91 >91 0-25 >25 % of 19 Pts Day 0 11% 16% 64% 9% 27% 73% % of 19 Pts Day 30 28% 26% 42% 4% 54% 46% % of 19 Pts Day 60 38% 19% 41% 2% 57% 43% % of 19 Pts Day 90 43% 21% 34% 2% 64% 36% % of 19 Pts Day 180 44% 16% 35% 4% 61% 39% Better Worse Same % of 19 Pts Day 0 % of 19 Pts Day 30 81% 14% 5% % of 19 Pts Day 60 91% 8% 1% % of 19 Pts Day 90 88% 10% 2% % of 19 Pts Day 180 91% 8% 1% TABLE 3 PATIENT SYMPTOM VAS (0-10) Day 0 Day 30 Day 60 Day 90 Day 180 Burning 2.1 0.5 0.8 0.9 0.7 Pain 4.1 1.2 1.4 1.1 1.2 Numbness 3.1 1.6 1.2 1.1 2.0 Tingling 3.9 1.1 0.8 0.5 0.5 Discoloration 1.1 0.5 0.4 0.3 0.3 Swelling 2.1 0.4 0.4 0.1 0.6 Aching 3.2 1.1 0.6 1.2 1.1 Itching 0.8 0.2 0.5 0.5 0.5 Stiffness 2.0 0.9 0.7 0.6 0.9 Ankles Sx 3.2 1.1 0.8 1.2 0.8 AVERAGE VAS 2.6 0.9 0.8 0.8 0.8 TABLE 4 PERCENTAGES OF PATIENTS WHO WERE SYMPTOM FREE
  • 9. 9 Day 0 Day 30 Day 60 Day 90 Day 180 Foot Burning 61% 76% 74% 74% 76% Foot Pain 26% 58% 63% 63% 68% Foot Numbness 53% 58% 63% 58% 66% Foot Tingling 37% 63% 74% 74% 74% Foot Discoloration 79% 89% 89% 89% 89% Foot Swelling 42% 82% 87% 92% 79% Foot Aching 37% 66% 74% 63% 71% Foot Itching 84% 87% 89% 84% 82% Foot Stiffness 55% 74% 79% 74% 71% Ankle Pain/Swelling 42% 63% 68% 39% 74% TABLE 5 VAS, VPT, AND NCV OF THE 16 PATIENTS WHO HAD ALL OF THE TESTING DAY 0 TO 180 VAS SYMPTOMS VPT VPT NCV IMPROVED IMPROVED NCV NORMAL PATIENT PAIN TINGLING >25 DAY 0 >25 DAY 180 DAY 180 DAY 180 DAY 180 PATIENT 1 5 ---> 0 5 ---> 0 10 0 10 / 10 10 / 12 12 / 12 PATIENT 3 2 ---> 1 6 ---> 1 10 10 10 / 10 9 / 12 7 / 12 PATIENT 4 10 ---> 2 10 ---> 2 4 0 10 / 10 9 / 12 9 / 12 PATIENT 5 10 ---> 4 10 ---> 2 10 3 10 / 10 7 / 12 11 / 12 PATIENT 6 0 ---> 0 0 ---> 0 7 2 10 / 10 4 / 12 12 / 12 PATIENT 7 0 ---> 0 0 ---> 0 7 7 10 / 10 5 / 12 10 / 12 PATIENT 8 1 ---> 0 9 ---> 0 10 10 8 / 10 6 / 12 0 / 12 PATIENT 9 4 ---> 3 5 ---> 3 10 10 5 / 10 3 / 12 0 / 12 PATIENT 10 5 ---> 0 1 ---> 1 5 0 10 / 10 5 / 12 8 / 12 PATIENT 11 0 ---> 0 0 ---> 0 1 0 10 / 10 6 / 12 4 / 12 PATIENT 12 8 ---> 0 8 ---> 0 10 10 8 / 10 1 / 12 0 / 12 PATIENT 14 6 ---> 3 4..5 ---> 0 10 8 9 / 10 0 / 12 0 / 12 PATIENT 15 2 ---> 0 0 ---> 0 0 0 10 / 10 12 / 12 12 / 12 PATIENT 16 5 ---> 0 5 ---> 0 10 10 3 / 10 1 / 12 0 / 12 PATIENT 18 0 ---> 0 4 ---> 0 4 0 10 / 10 3 / 12 6 / 12 PATIENT 19 2..5 ---> 0 1 ---> 0 10 2 10 / 10 5 /12 8 / 12 DISCUSSION Three different types of measurements were used to determine the improvement of the participants of this pilot study, NCV, VPT, and the patients’ VAS rating of symptoms.
  • 10. 10 Semmes-Weinstein monofilament testing was not utilized due to the possible problems with reproducibility and lack of quantification. In addition, when mono-filament testing has been compared to VPT >25V, it was found that a significant number of patients were identified at risk with VPT had been not been identified by the mono-filament testing. (14)(15)(16) Nerve conduction velocity testing is widely accepted as a methodology for determining peripheral neuropathies by testing hypoesthesia of A-beta neurons. There is strong correlation between NCV and VPT testing, and research has shown that these tests can predict foot ulceration and death in diabetes. (17)(18)(19)(20)(21)(22) After the NCV testing at day 90 and particularly after the NCV at day 180, virtually all of the participants complained that the testing was painful. No participant complained of the pain caused by the NCV testing before the study started. Vibration perception sensitively reflects disturbances in the function of fast adapting mechanoreceptors and of thick myelinated sensory nerve fibers. Both are commonly affected in diabetes. VPT measurements using a bioesthesiometer have been demonstrated to be reproducible under different levels of blood glucose, at different hours of the day, ambient temperature, and skin temperature. It has been shown that increased disease duration leads to significantly higher VPT readings in diabetic patients. Also it has been shown that VPT has a significantly higher specificity than neuropathy score. (23)(24) (25)(26)(27) It has been demonstrated that VPT shows twice the prevalence of abnormality compared with clinical examination or clinical evidence of neuropathy. (28)(29) VPT has been shown to be a good predictor of the long-term complications of diabetic peripheral neuropathy. It has been shown that patients with a VPT<15V. have had a cumulative incidence of foot ulceration of 2.9% compared with 19.8% in patients with a VPT>25V. The average individual with reduced vibration detection (>25V.) is estimated to incur approximately five times more direct medical costs for foot ulcer and amputations than an average individual with normal VPT (<15 V.). (30)(31) While some clinics only test the great toe for sensitivity and specificity for VPT to determine LOPS, other studies have shown that there is a great variability between testing sites. In addition, studies have shown that variability between sites was significantly greater in the diabetics than the nondiabetic subjects. (32)(33)(34)(35) The results of the VPT testing were analyzed utilizing the Friedman test and computed using the statistical package SPSS. The null hypothesis was rejected at p <.001. Therefore, it was found that a statistically significant difference was apparent. The Wilcoxon signed rank test with the Bonferroni adjustment was also used to evaluate the VPT data. The improvement was found to be significant at the 0.002 level. It has been shown by numerous investigators, that a reduction or impaired blood flow and the resultant endoneurial hypoxia are important factors underlying nerve conduction deficits. Studies have demonstrated that there is a good correlation between the degree of microangiopathy and measures of neuropathic severity in diabetics. It has also been
  • 11. 11 shown that with a return of more normal blood flow, there is a normalization of nerve conduction. (36)(37)(38)(39)(40) Other researchers have shown that revascularization surgery and hyperbaric oxygenation significantly increased the transcutaneous oxygen tension and the oxygen tension in ischemic tissues. However, no differences were noticed in the vibration perception threshold, NCV or Semmes-Weinstein monofilament measurements. (41)(42)(43)(44) (45) It has been observed that the cAMP level in diabetic nerves is decreased and that the decrease in nerve conduction is proportional to the reduction in cAMP. It has been shown that cAMP content may play an important role in the development of diabetic neuropathy by modulating Na+, K+, and ATPase activity in the peripheral nerves. It has been shown that electrical stimulation of nerves can increase nerve blood flow and nerve conduction and significantly increased intracellular cAMP, which allows peripheral nerve regeneration. (46)(47) In addition, it has been shown that these treatments can normalize nerve transmission and increase circulation to the nerves. It has been shown that this is due to the release of Calcitonin gene-related peptide (CGRP) and Vasoactive Intestinal Polypeptide (VIP). (48)(49)(50)(51)(52)(53)(54)(55)(56)(57)(58)(59)(60)(61)(62)(63) (64)(64)(65) CONCLUSIONS In this pilot study, five different sites of each foot were tested. These included the plantar aspect of the head of the hallux proximal phalanx head, the plantar aspect of the 1st and 5th metatarsal heads, the medial malleolus, and the lateral malleolus. It was found that there was a great variation between testing sites, which matches previous results cited. There was a marked improvement in the VPT scores through the study and there was a 400% increase in the testing sites rated as “normal” (VPT <15) when the 180-day scores were compared to day 0. When the testing sites which were considered to have LOPS (VPT >25) at day 0 were compared to results on day 180, 47% of those sites were no longer considered to have LOPS. Earlier in this article, there was an estimate given that the long-term complications of diabetic peripheral neuropathy experienced by the 2.4 million people in the U.S. with reduced vibration detection will cost all U.S. health care payers approximately $14.7 billion over the next 10 years. If all the patients with LOPS received therapy with comparable results to this study, it would be estimated savings of $6.9 billion. In this study, there was a marked improvement in NCV, particularly in the peroneal nerves. Many of the nonresponsive nerves became responsive with treatment and, since diabetic neuropathies continue to worsen with time, even maintenance of NCV would be an improvement. The participants evaluated their symptoms throughout the study and rated them on a scale of 0-10. At the beginning of the study, the overall VAS was 2.6. Beginning at 30 days and extending through the end of the 180-day study, the VAS was less than 1.0. The
  • 12. 12 average pain in the feet was rated at 4.1 but had reduced to 1.2 at 30 days and continued at approximately that level throughout the study. The best improvement was in the reported average tingling, which was 3.9 at the beginning of the study and had dropped to 0.5 by 90 days and remained there for the rest of the study. In actuality, all of the participants’ symptoms markedly improved and remained improved for the remainder of the study. As is apparent in tables 4 and 5, a significant number of the participants became symptom free, even as early as 30 days into the study. All of these symptoms decreased in severity throughout the study, with the exception of ankle symptoms. While the ankle symptoms decreased from day 0 through day 60, they were increased by day 90. In all probability, this was due to the markedly increased activity of the participants as the study progressed and the participants felt better. The ankle symptoms did decrease by the end of the study. The percentage of patients who did not have pain or tingling in their feet increased from 26% to 58% and from 37% to 63% respectively. Table 6 compares patients’ perception of pain and tingling in their feet with the objective findings of VPT and NCV. As can be seen from this table, there was a good correlation between the decreased patients’ symptom VAS scores and improved VPT findings, as well as, VPT improvements and NCV improvements. In reviewing this study's results, it could be hypothesized that improved circulation to the nerves resulted in the improvement in the diabetic peripheral neuropathy patients. The hypothesis for this study is that the STS treatments are effective due to a combination of the following aspects of the treatments: low frequency electrical current passing through long sections of nerves, production of cyclic adenosine monophosphate, electrode pad placement (including acupuncture points), the choice of the peripheral nerves being stimulated so that there is a cross-over effect in the CNS, leakage of action potentials from the nerves being stimulated into nerves entering the sympathetic ganglia, the quadrilateral location of stimulation, creation of action potentials through sympathetic nerves in the peripheral nerves being stimulated, production of ACTH, production of dynorphins, enkephalins or beta-endorphins, creation of action potentials through sympathetic nerves in the peripheral nerves being stimulated which enter the sympathetic ganglia directly, local analgesia resulting in a decrease of substance P; and/or the production of melatonin and circulation altering neuropeptides such as vasoactive intestinal polypeptide (VIP) and calcitonin gene-related peptide (CGRP). In addition, utilizing this therapy to relieve painful areas in the participants’ bodies diminished the amount of substance P and, therefore, would increase nerve oxygenation due to increased effectiveness of CGRP. (66) Further studies of this technology need to be performed. These future studies should include controls and greater number of participants. In addition, if it can be demonstrated that this therapy was effective due to the increase in neuropeptides such as CGRP and VIP, further studies will need to be performed to demonstrate its effectiveness in treating the underlying biochemical pathologies of related diseases such as Parkinson’s Disease. This small pilot study showed the effectiveness of this treatment for symptomatic and objective improvement of the peripheral neuropathies in patients with diabetes type 2.
  • 13. 13 Finally, all of medicine revolves around the patient’s perception of their health. Therefore, the most important improvement for the participants was shown in their rating of their symptoms rather than the improvement in the objective testing. 84% of the study participants stated that they felt better or much better after one week of treatment and more than 90% felt better or much better after 30 days of treatment and throughout the rest of the study. REFERENCES (1) Young MJ, Boulton AJ, MacLeod AF, Williams DR, Sonksen PH. “A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population.” Diabetologia. 1993 Feb; 36(2):150-4.) (2) van der Naalt J, Fidler V, Oosterhuis HJ. “Vibration perception threshold, complaints and sensory examination in diabetic patients.” Acta Neurol Scand. 1991 May; 83(5) 297-300. (3) Bosi E, Conti M, Vermigli C, Cazzetta G, Peretti E, Cordoni MC, Galimberti G, Scionti L. “Effectiveness of frequency-modulated electromagnetic neural stimulation in the treatment of painful diabetic neuropathy.” Diabetologia. 2005 May; 48(5):817-23. Epub 2005 Apr 15.) (4) Gordois A, Scuffham P, Shearer A, Oglesby A: “The health care costs of peripheral neuropathy for people with diabetes in the U.S.” Diabetes Care 26:1790–1795, 2003. Young MJ, Breddy JL, Veves A, Boulton AJ. (5) Poncelet AN: Diabetic polyneuropathy: risk factors, patterns of presentation, diagnosis, and treatment (Review). Geriatrics 58:16–18, 24–25, 30, 2003. (6) Vileikyte L, Rubin RR, Leventhal H: Psychological aspects of diabetic neuropathic foot complications: an overview. Diabetes Metab Res Rev 20 (Suppl. 1):S13–S18, 2004. (7) MJ Young, JL Breddy, A Veves, and AJ Boulton. “The prediction of diabetic neuropathic foot ulceration using vibration perception thresholds: a prospective study.” Diabetes Care 17:557–560, 1994. (8) Arran Shearer, MSc, Paul Scuffham, PHD1, Adam Gordois, MSC1 and Alan Oglesby, MPH. “Predicted Costs and Outcomes From Reduced Vibration Detection in People With Diabetes in the U.S. Diabetes Care 26:2305-2310, 2003. (9)Calle-Pascual AL, Durán A, Benedi A, Calvo MI, Charro A, Diaz JA, Calle JR, Gil E, Maranes JP, Cabezas-Cerrato J. “A preventative foot care programme for people with diabetes with different stages of neuropathy.” Diabetes Res Clin Pract 57:111–117, 2002.
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