Accuracy of monofilament testing to diagnose peripheral neuropathy: a systematic review.

PURPOSE We wanted to summarize evidence about the diagnostic accuracy of the 5.07/10-g monofilament test in peripheral neuropathy. METHODS We conducted a systematic review of studies in which the accuracy of the 5.07/10-g monofilament was evaluated to detect peripheral neuropathy of any cause using nerve conduction as reference standard. Methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) tool. RESULTS We reviewed 173 titles and abstracts of articles to identify 54 potentially eligible studies, of which 3 were finally selected for data synthesis. All studies were limited to patients with diabetes mellitus and showed limitations according to the QUADAS tool. Sensitivity ranged from 41% to 93% and specificity ranged from 68% to 100%. Because of the heterogenous nature of the studies, a meta-analysis could not be accomplished. CONCLUSIONS Despite the frequent use of monofilament testing, little can be said about the test accuracy for detecting neuropathy in feet without visible ulcers. Optimal test application and defining a threshold should have priority in evaluating monofilament testing, as this test is advocated in many clinical guidelines. Accordingly, we do not recommend the sole use of monofilament testing to diagnose peripheral neuropathy.