Controlled Randomized Double Blinded Prospective Study on The Role Of Surgical Decompression of Lower Extremity Nerves for The Treatment of Patients with Symptomatic Diabetic Neuropathy with Chronic Nerve Compression
Shai M. Rozen, M.D.1, Gil Wolfe, MD2, Phil Raskin, MD3, Steve Vernino, MD4, Geetha Pandian, MD5, Kathleen Wyne, MD3, Shiv Sharma, MD6, Joan Reisch, Ph.D.7, Linda Hynan, MD7, Rita Fulmer, RN5, Toni Salvatore, BS1.
1Department of Plastic Surgery; University of Texas Southwestern Medical Center, DALLAS, TX, USA, 2Department of Neurology; University at Buffalo, Buffalo, NY, USA, 3Division of Endocrinology; University of Texas Southwestern Medical Center, DALLAS, TX, USA, 4Department of Neurology, University of Texas Southwestern Medical Center, DALLAS, TX, USA, 5Department of Physical Medicine & Rehabilitation; University of Texas Southwestern Medical Center, DALLAS, TX, USA, 6Department of Anesthesiology; University of Texas Southwestern Medical Center, DALLAS, TX, USA, 7Department of Clinical Science; University of Texas Southwestern Medical Center, DALLAS, TX, USA.
An estimated fifty-percent of 74.8 million pre-and diabetic patients in the USA suffer from Painful Diabetic Neuropathy (PDN), approximately one-third prone to nerve compression. Previous studies suggest surgical decompression alleviates pain, however the American Neurological Association considers available evidence level U (Unproven). We present a seven-year NIH and institutionally funded, controlled randomized double-blinded prospective study to determine the long-term effect of nerve decompression in patients with PDN.
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 non-surgical-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 one-year, and four-year evaluations were performed.
Of 2987-screened patients, 138 enrolled: 92 randomized to surgery and 46 as controls. 40 surgical and 27 controls completed the study. At one 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 while 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.
Surgical decompression in patients with PDN unequivocally reduces bilateral pain with statistical significance at one year and continued bilateral improvement at four years, yet demonstrates more statistically significant pain reduction in the decompressed side at four years.
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