Surgical peripheral nerve decompression for the treatment of painful diabetic neuropathy of the foot - A level 1 pragmatic randomized controlled trial.

Abstract

AIMS\nTo assess the efficacy of surgical decompression of lower extremity nerves for the treatment of painful diabetic peripheral sensorimotor polyneuropathy (DPN).\n\n\nMETHODS\nPeople with painful diabetic neuropathy were randomized single-blind to a lower extremity decompression surgery (n\u202f=\u202f12) or observation (n\u202f=\u202f10) for 1\u202fyear.\n\n\nRESULTS\nPain was the primary outcome assessed with 2 measures. The McGill pain visual analogue scores over time changed within the groups (p for time\u202f<\u202f0.0001), and changed differently over time within the groups (p for group\u202f×\u202ftime\u202f=\u202f0.0138). The NeuroQoL pain sensitivity analysis significantly changed from baseline to 12\u202fmonths comparing intervention to control (p\u202f=\u202f0.0079), and the joint effect of group and time on pain scores was statistically significant (p for group\u202f×\u202ftime\u202f=\u202f0.0009). At the study end-point of 12\u202fmonths, intervention group participants had over 3 times the odds of rating their pain as better compared to unchanged or worse in the control group (p\u202f=\u202f0.0177).\n\n\nCONCLUSIONS\nSurgical decompression of lower limb nerves was an effective treatment for decreasing pain in patients with DPN and superimposed nerve compressions.