A 5-year Follow-up of the Lower Extremity Nerve Entrapment Study: Surgical Decompression in Patients with Painful Diabetic Neuropathy
Jasper L. de Kleijn, Bsc1; Willem D. Rinkel, MD2; J. Henk Coert, MD, PhD1; Joanne M.F Macaré van Maurik, MD, PhD3
1University Medical Center Utrecht, Utrecht, Netherlands, 2Erasmus Medical University Center / St. Franciscus Gasthuis, Rotterdam, Netherlands, 3Rivierenland Hospital, Tiel, Netherlands
Introduction: Patients with diabetes mellitus (DM) commonly show symptoms of diabetic polyneuropathy. These include sensations like burning, tingling and electrical sparks, but a loss of sensation is often observed as well. Therefore, patients with DM are at an increased risk of foot ulceration and lower extremity amputation. Nerve entrapments are common in patients with diabetes, and even more frequently in patients with polyneuropathy. It is in these patients lower extremity nerve decompression surgery may be a viable treatment option to reduce pain, the risk of ulceration and amputation by allowing recovery of nerve function.
Only one well-designed randomized controlled trial has been published so far. The Lower Extremity Nerve Entrapment Study (LENS), carried out in Utrecht, the Netherlands showed a reduction in VAS pain and an improvement in protective sensation at 12 months follow-up. However, the follow-up was too short to judge the effects of decompression surgery of lower extremity nerves on the incidence of ulceration and amputation. Therefore, we carried out a cross-sectional follow-up study of patients formerly participating in the LENS study to assess the sensation and the incidence of ulceration and amputation at five years follow-up.
Methods: All 42 participants of the LENS study were approached to participate in this follow-up study. The primary outcome was difference in sensation at the feet between the operated and non-operated legs. We assessed sensation with static- and moving two-point discrimination, set of 20 Semmes-Weinstein monofilaments (0.008 to 300 g), vibration sense, the ability to discriminate a cold stimulus, Romberg test and Tinel sign over the tarsal tunnel. The second outcomes assessed were on VAS-score, incidence of ulceration and amputation in operated and non-operated legs (patients were operated on one extremity) and quality of life.
Results: Data are analyzed now and will preferably be presented at ASPN 2017.
Conclusions: This first long-term follow-up of a well-designed randomized controlled trial will assess the value of nerve decompression surgery on sensation, pain, the incidence of ulceration and amputation and quality of life. This very important study will reveal the role of this type of nerve surgery in light of evidence-based medicine. Hence, we want to present the results of this analysis at the ASPN 2017 comparing them with baseline and 12 months outcome as well.
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