Effect of Vibration Anesthesia on Injection-Related Pain: A Prospective Crossover Study

Needle-based procedures, including intramuscular (IM) and subcutaneous (SC) injections and fingersticks, are essential to healthcare but frequently associated with pain and anxiety. Vibration anesthesia leverages the gate control theory by stimulating competing sensory pathways to reduce nociceptive transmission. DigiVibe (Suthe Dermal) is a handheld, FDA-registered vibration device designed to mitigate needle-related pain. This study evaluated DigiVibe's (Suthe Dermal) effect on pain during common needle procedures.

Twenty (20) healthy adults (50% female; mean age 37.5 years) reporting needle aversion underwent six procedures in a single visit including fingersticks, SC injections, and IM injections, each performed once without intervention (control) and once with DigiVibe (Suthe Dermal) applied before and during needle insertion. Pain was assessed immediately after each procedure using a 10-point Visual Analog Scale (VAS). Primary endpoints included mean paired VAS differences analyzed via Paired t-test and Wilcoxon signed-rank test.

DigiVibe (Suthe Dermal) significantly reduced pain across all procedure types. Mean VAS reductions were -2.65 for SC injections (p<0.001; d= -1.66), -2.00 for IM injections (p<0.001; d= -1.23), and -1.75 for fingersticks (p<0.001; d= -1.13). Nonparametric results confirmed large effect sizes (rank-biserial r = -1.0, -0.96, and -0.88, respectively). Sixty-five percent (65%) of subjects experienced no pain with DigiVibe (Suthe Dermal) during fingersticks and 95% achieved ≥30% pain reduction for SC injections. No adverse events occurred.

DigiVibe (Suthe Dermal) produced statistically significant and clinically meaningful reductions in pain across IM, SC, and fingerstick procedures in adults with needle aversion. These findings support vibration anesthesia as a safe, non-pharmacologic method to enhance comfort and potentially improve adherence to needle-based care.