Effect of Lower Extremity Nerve Decompression in Patients with Painful Diabetic Peripheral Neuropathy: The DNND Randomized, Observation Group- and Placebo Surgery-controlled Clinical Trial

Shai M Rozen; Gil I Wolfe; Steven Vernino; Philip Raskin; Linda S Hynan; Kathleen Wyne; Rita Fulmer; Geetha Pandian; Shiv K Sharma; Ahneesh J Mohanty; Cristina V Sanchez; Austin Hembd; April Gorman

doi:10.1097/SLA.0000000000006228

Effect of Lower Extremity Nerve Decompression in Patients with Painful Diabetic Peripheral Neuropathy: The DNND Randomized, Observation Group- and Placebo Surgery-controlled Clinical Trial

Ann Surg. 2024 Feb 8. doi: 10.1097/SLA.0000000000006228. Online ahead of print.

Authors

Shai M Rozen¹, Gil I Wolfe², Steven Vernino³, Philip Raskin⁴, Linda S Hynan^{5

6}, Kathleen Wyne⁷, Rita Fulmer⁸, Geetha Pandian⁸, Shiv K Sharma⁹, Ahneesh J Mohanty¹⁰, Cristina V Sanchez¹, Austin Hembd¹, April Gorman⁵

Affiliations

¹ Department of Plastic and Reconstructive Surgery, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
² Department of Neurology. University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.
³ Department of Neurology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
⁴ Division of Endocrinology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
⁵ Peter O'Donnell Jr. School of Public Health, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
⁶ The Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
⁷ Division of Endocrinology, Diabetes and Metabolism, Department of Internal Medicine, The Ohio State University, Wexner Medical Center, Columbus, Ohio, USA.
⁸ Department of Physical Medicine and Rehabilitation, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
⁹ Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
¹⁰ Now with the Section of Plastic and Reconstructive Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.

PMID: 38328975
DOI: 10.1097/SLA.0000000000006228

Abstract

Objective: Evaluate the effect of nerve decompression on pain in patients with lower extremity painful Diabetic Peripheral Neuropathy (DPN).

Summary background data: Currently, no treatment provides lasting relief for patients with DPN. Benefits of nerve decompression remain inconclusive.

Methods: This double-blinded, observation- and same-patient sham surgery-controlled randomized trial enrolled patients aged 18-80 years with lower extremity painful DPN who failed one-year of medical treatment. Patients were randomized to nerve decompression- or observation-group (2:1). Decompression-group patients were further randomized and blinded to nerve decompression in either right or left leg and sham surgery in the opposite leg. Pain (11-point Likert score) was compared between decompression and observation groups and between decompressed versus sham legs at 12 and 56 months.

Results: Of 2987 screened patients, 78 were randomized. At 12 months, compared with controls (n=37), both right-decompression-group (n=22) and left-decompression-group (n=18) reported lower pain (mean difference for both, -4.46; [95% CI, -6.34 to -2.58 and -6.48 to -2.45 respectively]; P<0.0001). Decompressed and sham legs equally improved. At 56 months, compared with controls (n=14), pain was lower in both the right-decompression-group (n=20) (mean difference, -7.65; [95% CI, -9.87 to -5.44]; P<0.0001) and left-decompression-group (n=16) (mean difference, -7.26; [95% CI, -9.60 to -4.91]; P<0.0001). Mean pain score was lower in decompressed versus sham legs (mean difference, 1.57 [95% CI, 0.46 to 2.67]; P=0.0002).

Conclusion: Although nerve decompression was associated with reduced pain, the benefit of surgical decompression needs further investigation since a placebo effect may be responsible for part or all of these effects.