Prospective clinical study for assessing real-time objective pain using a signal processing algorithm in conjunction with wearable forehead sensors.

Pain imposes an enormous personal and economic cost and is typically measured by patient self-report using subjective ratings such as the Numerical Rating Scale (NRS). However, subjective scales present limitations, and there is a need for objective assessment of patient pain. This study assessed the Real-time Objective Pain Assessment (ROPA) algorithm that uses optical spectrometry in conjunction with signal processing to capture continuous real-time objective pain measurements in a noninvasive, portable, and inexpensive way. In a prospective cohort study enrolling 130 women in labor receiving neuraxial analgesia, we tested the ROPA algorithm using two wearable sensors, one of the many commercially available devices (ForeSight Elite) and a novel forehead sensor developed by CereVu Medical. Patient pain rating using the NRS served as ground truth. The ForeSight Elite and CereVu devices respectively demonstrated a receiver operating characteristic area-under-the-curve of 0.95 and 0.93 for no/mild vs. severe pain, 0.90 and 0.86 for no/mild/moderate vs. severe pain, and 0.88 and 0.87 for no/mild vs. moderate/severe pain. Overall, we successfully distinguished between pain levels and plan further multi-center clinical validation.