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The DNND (Diabetic Neuropathy Nerve Decompression) II Study: A 10-Year Follow-Up on a Randomized Controlled Double Blinded Study on The Effect of Nerve Decompression on Pain and Narcotic Dependence in Patients with Diabetic Peripheral Neuropathy
Ahneesh J Mohanty, BA1, Shaida Khan, DO2, Steven Vernino, MD3, Peter Crisologo, DPM2, Javier LaFontaine, DPM2, Larry Lavery, DPM2 and Shai M. Rozen, MD4, (1)University of Texas Southwestern Medical Center Department of Plastic Surgery, Dallas, TX, (2)The University of Texas Southwestern Medical Center, Dallas, TX, (3)UT Southwestern Medical Center, Dallas, TX, (4)Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, TX

Introduction: Diabetic Peripheral Neuropathy (DPN) is a debilitating condition of increasing incidence, affecting an estimated 45% of diabetics. DPN is usually treated pharmacologically with analgesics, however, 10% of patients report a reliance on daily narcotic analgesia for relief. The proposed etiology of this condition potentiates the benefits of nerve decompression in pain alleviation, however, its exact benefits remain unclear. The Diabetic Neuropathy Nerve Decompression (DNND) study was a randomized, prospective, controlled, double-blinded study proposed in 2008 to evaluate the role of nerve decompression on DPN. In this trial, 2987 patients were screened, and 138 patients were enrolled in the study. Surgical patients underwent surgery bilaterally with each side randomized to nerve decompression or sham surgery, and patients and final evaluators were blinded to side. We present a ten-year follow-up on this population to determine the long-term effect of decompression in patients with DPN on pain and neurophysiologic parameters. Previous data from our trial have shown improvement in subjective pain score over the ten-year follow-up period, however, its impact on chronic narcotic usage remains to be elucidated.
Materials and Methods: During this blinded follow-up visit, a multidisciplinary team performed follow-up pain, podiatric, and electrophysiologic evaluations on surgical and control patients. Narcotic requirements were calculated at each visit in terms of Milligrams Morphine Equivalents per day (MME/day) according to standardized conversions.
Results: All 24 surgical and 12 control patients who participated in DNND II and reported reliance on chronic narcotics at any point during the trial were included in this analysis. HbA1c levels were found to be homogeneous in all groups at all evaluations. At baseline and the 12 month follow-up visit, no significant differences in mean daily narcotic requirements existed between either group. From baseline to the 10-year follow-up, the surgical group experienced a significant mean reduction in MME/day requirements of -23.3 MME/day (p=0.0001) versus control which experienced no significant changes in narcotic use from baseline (p=0.98). Two-way repeated measures ANOVA revealed significant interaction between time and surgery (p=0.027), indicating greater decrease in MME/day over time in surgical patients as compared to control patients.
Conclusion: The findings of this study show that peripheral nerve decompression provides long-term analgesic benefits in patients with DPN, through decreased subjective pain scores as previously reported, and decreased reliance on chronic narcotic use. Thus, peripheral nerve decompression may prove beneficial in select patients with DPN.


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