The UVB cutaneous inflammatory pain model: a reproducibility study in healthy volunteers.

BACKGROUND The human ultraviolet-B (UVB) experimental pain model induces cutaneous neurogenic inflammation, involves hyperalgesia, and is widely used as a pharmacological screening pain model. AIM To estimate the test-retest reliability of the UVB pain model by application of a comprehensive set of vasomotor and quantitative sensory assessment methods and to estimate sample sizes required for parallel or crossover pharmacological screening studies when this model is considered to be applied. METHODS The upper arms of 15 healthy male volunteers were UVB irradiated with three times the minimal erythema dose. Neurogenic inflammation was assessed by measuring erythema index, superficial blood flow and skin temperature at baseline, 1 day, 2 days and 3 days post irradiation. Sensory changes were assessed by brush stroke, von Frey hairs, pressure algometry, heat-evoked pain, stimulus response function to weight calibrated pin-prick stimulation, and the area of secondary hyperalgesia. The experiment was repeated with a two-week interval. Systematic bias, Coefficient of variation (CV), and intra-class correlation (ICC) were calculated within and between UVB irradiations. The sample sizes for parallel and crossover studies were calculated. RESULTS Neurogenic inflammation (erythema index) and primary hyperalgesia (pin-prick stimulation) remained significant for 3 days, and were highly reproducible within and between the UVB irradiations resulting of low sample sizes (4-26) in both parallel and crossover studies. CONCLUSION Based on sample size calculations, it is recommended to use the erythema index to assess neurogenic inflammation, and pin-prick stimulation for primary hyperalgesia for both parallel and crossover pharmacological screening studies.