Evaluation of SET–A New Device for the Measurement of Pain Perception in Comparison to Standard Measures of Diabetic Neuropathy

Abstract

Early detection of sensory impairment and loss of protective pain sensation is of major importance for the prevention of neuropathic foot ulceration. The aim of our study was to evaluate a new handheld device (SET, a prototype developed by Dr. W. Henniges, Zülpich, Germany) for measurement of pain perception, in comparison with established methods for diagnosis of diabetic neuropathy. Sixty-one patients with diabetes mellitus (13 type 1, 48 type 2; 42 men, 19 women; mean +/- SD age 61.6 +/- 11.6 years) received measurement of pain perception threshold using the new SET device and a measurement of light touch sensation, temperature sensation, and vibration sensation by the use of standard clinical devices. In addition, warm, cold, heat pain and vibration perception thresholds were determined by the use of a computer-based peltier thermode and a vibration stimulator (TSA 2001, Medoc, Ramat Yishai, Israel). Using the new SET device, patients with sensory impairment showed significantly elevated pain perception thresholds at the dorsum of the foot (P < 0.001), while only a trend towards higher measurements could be observed at the plantar aspect of the foot. A significant correlation could be observed between plantar and dorsal measuring sites (r = 0.78, P < 0.0001) and between both feet (r = 0.85, P < 0.0001). Compared with other qualities of sensory dysfunction, pain perception measurement with the SET device provided the highest sensitivity (pain = 0.82; vibration = 0.61; temperature = 0.42; light touch = 0.11). Measurement of pain perception threshold using the SET device is an easy and reliable method for identifying patients with impaired small nerve fiber function.