| Pierre L. LeRoy, MD, FACS |
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Date: September 19, 2001 I wish to thank your company, Electromedical Products International, Inc., for lending the Delaware Pain Clinic program the FDA approved Alpha-Stim® units for clinical trials to evaluate and treat chronic, refractory neuropathic and myofacial pain syndromes, without any financial interests. Our limited trials of ten patients who had both Somatic and Psychological diagnosis - were drug free and provided informed consent agreements. We were very impressed they demonstrated significant clinical improvements. This group included non-operative, pre-operative, and post-operative treatments. The results were encouraging enough to recommend a larger series for clinical trials in order to accumulate more data, to better determine efficacy to avoid more complex neuroaugmentive or ablative neurosurgical procedures by spinal and brain stimulators, and trial of post-operative patients who have significant residual pain syndromes as adjunctive therapy for those who are drug sensitive or intolerant. |