A Pilot Trial of Peripheral Nerve Decompression for Painful Diabetic Neuropathy (P01.125)

OBJECTIVE: To study clinical and electrophysiologic outcomes of patients undergoing peripheral nerve decompression for painful diabetic neuropathies. BACKGROUND: Despite extensive research there is no clear understanding of the pathophysiology of diabetic neuropathy. One approach that has emerged is the concept of decompressing nerves that are commonly entrapped in diabetes. Unfortunately there is no consensus on how entrapped nerves can be identified as nerve conduction studies (NCS) often do not detect abnormalities or may be difficult to reliably obtain. Anecdotally many patients report improved pain and sensibility following decompression surgeries however prospective studies evaluating changes in symptoms, and electrophysiology have been limited. DESIGN/METHODS: 10 patients with painful diabetic neuropathy who chose to undergo peripheral nerve decompression were enrolled. Patients were given a HR-QOL, PGI, NPS, and BPI questionnaires at screening to evaluate initial pain and severity of their neuropathy. Neurological, Physical Exams, strength, skin biopsies for epidermal nerve fiber density and NCS were performed preoperatively. Peroneal and tibal nerves were assessed by Medtronic9s Nerve Integrity Monitor 3.0 intraoperatively before and after decompression. Immediately post operatively, NCS and neurological exams were assessed. Repeat exams were performed at weeks 4 and 12 with repeat skin biopsies and NCS at 12 and 24 weeks. RESULTS: To date there is a clear trend for improvement in NCS even at sites where no compression was demonstrated pre-operatively suggesting compression may be present in some nerves that cannot be demonstrated by routine NCS. Improvements in distal toe strength in patients with toe extensor weakness were noted. Final data for all of the outcome measures will be collected and analyzed before the meeting in April. CONCLUSIONS: Peripheral nerve decompression for painful diabetic neuropathy may have validity in the treatment of symptoms of diabetic neuropathy. A larger controlled multi-center study is indicated. Disclosure: Dr. Levine has received personal compensation for activities with Lilly, Pfizer, Griffolw, and Baxter. Dr. Levine has received research support from Synthetic Biolgics and Questcor Pharmaceuticals. Dr. Barrett has nothing to disclose. Dr. Hank has nothing to disclose. Dr. Yamasaki has received personal compensation for activities with Medtronic, Inc as an employee. Dr. Yamasaki holds stock and/or stock options in Medtronic, Inc., which sponsored research in which Dr. Yamasaki was involved as an investigator. Dr. Nickerson has nothing to disclose. Mr. Hacker has received personal compensation for activities with Medtronics as an employee. Mr. Hacker holds stock in Medtronics. Dr. Saperstein has received personal compensation for activities with Talecris, CSL Behring, Eli Lilly,Corinthian reference lab, as speaker, scientific advisory board and neuropathy services.