Delayed-onset muscle soreness: a pilot study to assess analgesic study design features.

Based on a thorough review of the available literature in the delayed-onset muscle soreness (DOMS) model, we identified multiple study design characteristics that are considered to be normative in acute pain research but have not been followed in a majority of published DOMS experiments. We designed an analgesic investigation using the DOMS model that both complied with current scientifically accepted standards for the conduct of analgesic studies and demonstrated reasonable assay sensitivity. This randomized, double-blind, placebo-controlled within-subject study compared the efficacy of topical diclofenac sodium 1% with a matching placebo in reducing pain associated with DOMS. After exercise, subjects reporting DOMS received topical diclofenac sodium gel 1% (DSG 1%) applied to one leg and placebo to the other every 6 hours for 48 hours. Pain intensity was assessed at rest, upon standing, and when walking in the 48 hours after initial drug application (T0). The primary end point was the reduction in pain intensity (SPID 24) on walking. Subjects receiving DSG 1% had less pain while walking compared with those receiving placebo at 24 hours (SPID 24 = 34.9 [22.9] and 23.6 [19.4], respectively; P = 0.032). This investigation used experimental techniques that have been vetted in the field of exercise physiology and superimposed techniques that are considered to be best practice in the field of analgesic research. Over time and with the help of colleagues in both fields of study, similar investigations will validate design features that impact the assay sensitivity of analgesic end points in DOMS models. In addition, the study confirmed the analgesic efficacy of topical DSG 1% over placebo in subjects experiencing DOMS.