The Dnnd (diabetic Neuropathy Nerve Decompression) 2 Study: A 10-year Follow-up Of The Controlled Randomized Double Blinded Prospective Study On The Effect Of Lower Extremity Nerve Decompression On Pain And Neurophysiology In Patients With Symptomatic Diabetic Neuropathy With Chronic Nerve Compression
Shai M. Rozen, M.D.1, Ahneesh J. Mohanty, BA1, Shaida Khan, DO2, Steven Vernino, MD, PhD2, Peter Crisologo, DPM1, 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: Painful Diabetic Neuropathy (PDN) is a debilitating condition affecting an estimated 80 Million pre-and diabetic patients in the USA. Although the American Neurological Association considers nerve decompression in PDN as level U (Unproven) evidence, previous studies, including the DNND1 study suggest benefits. We present a ten-year follow-up on an NIH and institutionally funded prospective, controlled, randomized double-blinded study determining the long-term effect of decompression in PDN patients on pain and neurophysiologic parameters. Methods: Pain (Likert 0-10) and electrophysiologic evaluations were performed on surgical and control patients previously enrolled in the DNND1 study. Surgical patients underwent surgery bilaterally, each side randomized to decompression or sham surgery. Patient and final evaluators were blinded to side. Results: The DNND1 study included 2987-screened patients and 138 enrollees: 92 randomized to surgery and 46 controls. 40 surgical and 27 controls completed DNND1. Of those, 28 surgical and 21 controls completed the 10-year DNND2 follow-up. The surgical group experienced a significant reduction in pain of 6.95 (SD=1.33) in the surgical leg compared to 6.13 (SD=3.31) in the sham leg (p=0.018) while the control group had no significant pain reduction in either leg. Compared with baseline, surgical legs had greater improvement in distal tibial motor latency over sham (p=0.046) and control legs (p=0.031) and non-significant changes in distal amplitude (p=0.109) compared to amplitude deterioration observed in both sham and control legs (p=0.005,p=0.009). Conclusion: Surgical decompression in patients with PDN demonstrates statistically significant pain reduction, improved conduction velocities, and slowing of axonal loss in the decompressed side.
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