Effect Of Lower Extremity Nerve Decompression In Patients With Painful Diabetic Neuropathy On Narcotic Use And Ulceration Rates: A 10-year Follow-up From The Prospective, Controlled, Randomized, Double Blinded, Dnnd I And Dnnd Ii Trials.
Shai M. Rozen, M.D.1, Ahneesh J. Mohanty, MD1, Shaida Khan, DO2, Steven Vernino, MD, PhD2, Linda Hynan, PhD1, Javier LaFontaine, DPM1, Larry Lavery, DPM1.
1Department of Plastic Surgery, University of Texas Southwestern Medical Center, DALLAS, TX, USA, 2Department of Neurology, University of Texas Southwestern Medical Center, DALLAS, TX, USA.
Purpose: 10% of over 80 million American patients suffering from painful Diabetic Peripheral Neuropathy (DPN) rely on narcotics for pain relief. We present the 10-year follow-up from the Diabetic Neuropathy Nerve Decompression (DNND) I & II trials to determine the effect of nerve decompression on narcotic reliance and foot ulceration. Methods: The DNND I study, a prospective, randomized, patient and rater-blinded, observation group plus same-patient sham surgery-controlled trial with 5-year follow-up, evaluated the effect of nerve decompression on pain. The DNND II study consisted of 10 year follow ups on the same cohort. Narcotic requirements were calculated in Milligrams Morphine Equivalents per day (MME/day) through standardized conversions and podiatric foot exams recorded ulcerations.Results: Of 2987 screened patients, 138 were enrolled in DNND I - 92 randomized to surgery and 46 to controls. 24 surgical and 12 control patients who participated in all visits were included for analysis. Compared to baseline, at 12 months, surgical and control groups did not experience significant changes in MME/day requirements, but the surgical group experienced a significant reduction of -2.8 (p=0.004) at 56 months, and -23.3 (p=0.0001) at 10 years while controls experienced no change (p=0.96). Compared to control patients, surgical patients had similar mean MME/day requirements at 0 months (p=0.98) and 12 months (p=0.78), but lower requirements at 56 months (p=0.003) and 10 years (p=0.006). Prevalence of foot ulceration was similar between groups at 10 years (p=0.67).Conclusions: Nerve decompression provides long-term analgesic and decreased reliance on narcotics in DPN patients.
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