Barron Associates’ Pain Assessment Technology Completes Phase II SBIR Clinical Study

Chronic pain is an internal experience that cannot be directly observed or measured. Pain assessment, therefore, is exceptionally challenging, relying largely on self-report measures. The objective of this study is to develop and demonstrate the KnowPain system, an innovative wrist-worn instrument for objectively assessing the functional impact of pain (FIP) throughout the course of a patient’s treatment. The proposed approach will supplement existing methods for assessing patient function by providing novel, objective, and highly complementary information for a more complete (and often unobserved) picture of the impact of chronic pain on patient function during daily living.

The KnowPain wrist-worn instrument was tested with 100 chronic low back pain patients. KnowPain pain scores are based on a Multidimensional Item Response Theory (MIRT) model that transforms objective physiological and activity data collected by the instrument into normalized scores. Pain assessment scores generated by KnowPain were compared to standard assessment scores. Construct validity was demonstrated by achievement of statistical significance (p<0.05) compared to conventional psychometric instrument scores via multiple regression.