I was in attendance at the ADA Foot Care and Neuropathy Discussion session where the subject of decompression surgery came up. Chairman J. Peter Dyck, MD, Professor of Neurology Mayo Clinic, started a review of the surgery process and introduced A. Lee Dellon, MD Peripheral Nerve Surgeon, Professor at Johns Hopkins University, who has had great success with the procedure and Arthur I. Vinik MD, Streilitz Diabetes Institute, Professor Eastern Virginia College of Medicine, who questioned if the procedure really made a difference. The results may surprise you. To find out what went on read LOWER EXTREMITY NERVE DECOMPRESSION IN THE PATIENT WITH DIABETIC NEUROPATHY: IS THERE EVIDENCE?

REPORT FROM THE AMERICAN DIABETES ASSOCIATION MEETING
Dave Joffe, BSPharm, CDE, FACA

LOWER EXTREMITY NERVE DECOMPRESSION IN THE
PATIENT WITH DIABETIC NEUROPATHY: IS THERE EVIDENCE?

Andrew J. Boulton, MD, of the ADA Program Committee introduced this session, June 12, at 2:15PM, as the first of this type, and designed to highlight an area of increasing importance for patients with neuropathy as a complication of their diabetes. Dr. Boulton introduced the Chairman for the session, J. Peter Dyck, MD, Professor of Neurology at the Mayo Clinic and an icon of knowledge in the area of Diabetic Neuropathy.

Dr. Dyck began by defining the clinical problem to be addressed as the patient who presents with symptoms of numbness and/or pain in the feet and legs, bilaterally symmetrical, with sensory usually greater than motor symptoms, and being present in a length-dependent manner (worse distally). Dr. Dyck then proceeded, in the spirit of the Controversy Session to introduce the speaker for the “Pro” position, “in the blue trunks from the right corner of the ring” as A. Lee Dellon, MD, a Plastic Surgeon, Hand Surgeon, and Peripheral Nerve Surgeon, on faculty as Professor at Johns Hopkins University, in Baltimore, Maryland, and for the “Con” position, “in the red trunks from the left corner of the ring” as Arthur I. Vinik MD, from the Streilitz Diabetes Institute, in Norfolk, Virginia, and Professor at the Eastern Virginia College of Medicine.

Doctor Dellon began by reviewing his involvement as a Hand Surgeon with carpal tunnel syndrome in patients with diabetes. Patients, who typically had relief of their carpal tunnel syndrome, would ask him, “Dr. Dellon, you helped my hands, can you help my feet with symptoms of diabetic neuropathy?” Dr. Dellon reviewed the analogies between nerve compression in the hand, and applied anatomic investigations to understanding the sites of compression in the legs. As three separate nerves in the upper extremity (median, ulnar and radial) could provide a glove distribution, so too could the skin territories of the peroneal plus the tibial nerve create a stocking distribution.

Dr. Dellon reviewed his first series of patients with diabetes in whom he had decompressed multiple peripheral nerves, reported in 1992, and the overall 80% success rate for recovery of sensation. He then reviewed more than a decade of basic science studies in diabetic and non-diabetic rats and monkeys that supported the following thesis: 1) underlying metabolic abnormalities make the peripheral nerve in the diabetic susceptible to chronic nerve compression, and 2) in the absence of a site of anatomic narrowing, like the tarsal tunnel, the pathophysiologic walking consequences of diabetic neuropathy can be prevented.

He reviewed basic science work from Yuksel, et al, from Istanbul, Turkey, and Siemionow, et al, from the Cleveland Clinic that supported this thesis. Dellon then reviewed 14 clinical papers some in print, and some to appear in 2006, that, in a “meta-analysis” demonstrated, in a group of 833 patients, relief of pain in 86% and a recovery of sensibility of 81%. These surgeons had trained with Dellon in an Advanced Lower Extremity Peripheral Nerve Workshop, and used the same inclusion criteria, surgical technique, and outcome measures. These studies used an inclusion criteria that required a history of no previous ulceration or amputation, and the presence of a positive Tinel sign over the tibial nerve in the tarsal tunnel. These studies reported not a single new ulceration or amputation. Furthermore, in a prospective , multicenter , study available on line at http:/www. NeuropathyRegistry.com, 36 surgeons have accrued 524 diabetic patients with 737 operations (about 40% have had bilateral Dellon Triple Nerve decompressions), which confirm the relief of pain, sensory recovery, and prevention of new ulcers and new amputations.

Doctor Dellon concluded by indicating that there was “plenty of evidence”, basic science and clinical, that decompression of superimposed nerves in the patient with symptoms of diabetic neuropathy could bring the patient relief and change the natural history of diabetic neuropathy for those patients.

Dr. Vinik, in presenting the contrarian position, focused upon the necessity for making the correct diagnosis in the patient with diabetes and symptoms relating to the peripheral nerves. He noted that some forms of neuropathy in diabetics could resolve spontaneously and it would appear, therefore, as if their relief were due to the “healing hand of the physician”.

Dr. Vinik detailed the ability to relate small nerve fiber endings in the skin to painful neuropathy, and the possibility of relief of pain through drug treatment of these symptoms.

Dr. Vinik indicated that there were many studies related to pain relief that were likely the result of a placebo effect rather then efficacy of the purported treatment method itself, such as studies with infrared light, magnets, and vibration.

Dr. Vinik did agree that in the population of patients with diabetes, about one third of patients would have a compression of a peripheral nerve, but the problem lay with making that diagnosis in the face of the underlying neuropathy.

Dr Vinik pointed out the “false positive” rate attributable to the Tinel sign, and that some patients with carpal tunnel syndrome and a positive Tinel sign do not improve after surgery. Dr. Vinik voiced concern that although Dr. Dellon had demonstrated many clinical studies with suggestive good outcomes, there still had not been a randomized prospective study using a placebo or sham surgical procedure as a control group. Dr Vinik noted that surgery could be a powerful placebo.

In the discussion period that followed, Dr. Andrew Boulton, of the Program Committee for the ADA , thanked the participants for a spirited Controversy Session, and asked Dr. Dellon to clarify if he, Dr. Dellon, were suggesting that every diabetic with neuropathy should have this Dellon Triple Nerve decompression procedure. Dr. Dellon said that he was teaching that only those individuals with diabetes and a superimposed chronic nerve compression, as indicated by the presence of a distally radiating tingling or pain sign over the tibial nerve (a positive Tinel sign) were candidates for the procedure.

These individuals must also be in good glycemic control, have failed neuropathic pain medication, have no edema in the ankles, and have a ankle/brachial index for circulation sufficient to support healing.

Maria Siemionow, MD, PhD, DSc, from the Cleveland Clinic, said that her basic science and clinical research supported Dr. Dellon’s observations. Dr. Siemionow, who has been in the news recently related to her work in facial transplantation, indicated that there was sufficient evidence now for patients with symptomatic diabetic neuropathy to be referred for consultation to determine if they had superimposed nerve compressions which could be treated surgically.

Dr. Scott Nickerson, an Orthopedic Surgeon from Wyoming, commented that it was important for the American Diabetes Association to consider these surgical clinical reports, as they offered hope for patients who had little else to offer a chance for symptomatic improvement and prevention of ulcers and amputations. While he hoped the ADA might sponsor the type of randomized study that Dr Vinik called for, he indicated that he did not know if an Independent Review Board would approve the ethics of a sham surgery on the diabetic foot.

Dr. Craig Haberman, an Endocrinologist and Diabetologist from Hagerstown, Maryland, indicated that while he appreciated Dr. Vinik’s concern for the bias in Dr. Dellon, the surgeon’s reporting, he, Dr. Haberman felt that long lasting improvement in pain relief and sensory recovery demonstrated by Dr. Dellon’s and the other surgeon’s reports spoke against a placebo effect being present. Furthermore, Dr. Haberman added, Dellon’s group of 50 patients who had no ulcers or amputations in the operated leg, followed for a mean of 4.5 years, but who did develop 12 ulcers and 3 amputations in the non-operated contralateral leg ,also spoke against the presence of a placebo effect.

Dr. Larry Harkless, a past ADA Educator-of-the-Year in 2002, and Professor of Podiatric Medicine and Surgery in the Department of Orthopedics at the University of Texas Health Science Center, and Director of the National Diabetes Center in San Antonio, related how he initially had great skepticism of the work presented by Dr. Dellon. Then he invited Dr. Dellon to the National Diabetes Center at the University of Texas to do this surgery. Harkless observed directly, himself, the improvement in a patient that Dr. Dellon operated upon. Dr Harkless indicated that the Dellon Triple Nerve Decompression was now being taught to his surgical residents.

Finally, Dr. Bruce Shafiroff, a Plastic Surgeon from Syracuse, New York, reported his own observations on a series of more than 300 patients with diabetes for whom he has done Dellon’s surgical approach, indicating his success rate for pain relief and recovery of sensation was better than 80%. He urged the ADA not to make the same mistake with the acceptance of this breakthrough in patient care that the Gastroenterologists made when the bacteria, Helicobacter pylori, was first suggested to be the causative factor in gastric ulcers.

Shafiroff noted that in the ten years it took for the observations on H. pylori to become accepted, more 50,000 patients died, and that ultimately Barry J. Marshall, MD and J. Robin Warren, MD were awarded the 2005 Nobel Prize in Medicine and Physiology for their seminal observations.

Shafiroff’s analogy went on to indicate the 80,000+ amputations per year related to diabetic neuropathy could be stopped by application of the basic science and clinical principles Dr. Dellon presented at the session.

In summing up the Controversies session, Dr. Dyck and Dr. Vinik both agreed that peripheral nerve decompression would be appropriate for the patient with symptoms of diabetic neuropathy in whom a superimposed nerve compression could be identified, and that if it were possible to have a randomized controlled study of the promising results presented by Dellon, it would be worthwhile having such a study completed. It was speculated upon as to availability of funding for such a study. Doctor Boulton again thanked everyone for their participation.