PRS AAPS Oral Proofs 2016
Shai M. Rozen, MD,* Gil Wolfe, MD,† Phil Raskin, MD,‡ Steve Vernino, MD,§ Geetha Pandian, MD,¶ Kathleen Wyne, MD,‡ Shiv Sharma, MD,‖ Joan Reisch, PhD,** Linda Hynan, MD,** Rita Fulmer, RN,¶ Toni Salvatore, BS*
From the *Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, Tex.; †Department of Neurology, University at Buffalo, Buffalo, N.Y.; ‡Division of Endocrinology, University of Texas Southwestern Medical Center, Dallas, Tex.; §Department of Neurology, University of Texas Southwestern Medical Center, Dallas, Tex.; ¶Department of Physical Medicine and Rehabilitation; University of Texas Southwestern Medical Center, Dallas, Tex.; ‖Department of Anesthesiology, University of Texas Southwestern Medical Center, Dallas, Tex.; and **Department of Clinical Science, University of Texas Southwestern Medical Center, Dallas, Tex.
PURPOSE: An estimated 50% of 74.8 million prediabetic and diabetic patients in the Unites states suffer from painful diabetic neuropathy (PDN), approximately one-third prone to nerve compression. Previous studies suggest that surgical decompression alleviates pain; however, the American Neurological Association considers available evidence level U (unproven). We present a 7-year National Institutes of Health and institutionally funded, controlled randomized double-blinded prospective study to determine the long-term effect of nerve decompression in patients with PDN.
METHODS: A multidisciplinary neurology, endocrinology, PM&R, pain, and surgery group performed baseline pain examinations (Likert: 0–10, Neuropathy scores). Patients were randomized into surgical and nonsurgical control groups (2:1 ratio, respectively). Surgical patients underwent surgery bilaterally with each side randomized to nerve decompression or sham surgery. Patient and final evaluators were blinded to side. Quarterly, final 1-year, and 4-year evaluations were performed.
RESULTS: Of 2987 screened patients, 138 enrolled for the study: 92 randomized to surgery and 46 as controls. Forty surgical and 27 controls completed the study. At 1 year, the surgical group experienced a mean pain reduction of 5.70 in the surgical leg (SD = 2.09; P < 0.0001) and 5.25 (SD = 2.79; P < 0.0001) in the sham leg, whereas the control group had no statistically significant reduction of pain. A 54.5-month follow-up of 36 surgical patients revealed a mean pain reduction of 7.47 in the surgical leg (SD = 2.54; P < 0.0001) and 5.97 (SD = 2.43; P < 0.0001) in the sham leg.
CONCLUSIONS: Surgical decompression in patients with PDN unequivocally reduces bilateral pain with statistical significance at 1 year and continued bilateral improvement at 4 years, yet demonstrates more statistically significant pain reduction in the decompressed side at 4 years.