An Instrument to Assess the Functional Impact of Chronic Pain - Project Summary/Abstract
Evaluation and treatment for chronic pain are major contributors to rising healthcare costs. Although accurate
assessment of pain and function is the cornerstone to successful chronic pain management, systematic, objective
assessment of the functional impact of pain remains exceptionally challenging in practice. The intricate nature of
chronic pain demands a comprehensive, multi-mode assessment methodology that combines subjective Patient
Reported Outcomes (PROs) with objective data. There is signi cant potential to reduce the costs associated
with chronic pain and simultaneously improve outcomes by leveraging novel, cutting-edge sensing technology
and analytical methods to provide new pain assessment and treatment evaluation information.
The proposed Fast Track SBIR e ort will develop and validate the reliable, low-cost KnowPain instrument.
KnowPain will objectively and quantitatively assess the functional impact of chronic pain (FIP) using measures
derived from six degrees-of-freedom (6-DOF) motion, heart rate, skin surface temperature, and skin conductivity
collected via a specially designed, ergonomic wrist-worn biometric sensing instrument. The new assessment
instrument will apply advanced psychometric methods to both physiologic and kinematic data to provide precise
scores for functional impairment due to chronic pain. The validated instrument will be a fully-automated,
stand-alone product available to clinicians assessing and treating chronic pain in a variety of settings.
The KnowPain instrument will be worn by the patient for a period of up to one week, after which collected
data will automatically be uploaded and processed by the system's custom software using Multidimensional Item
Response Theory models. The assessment results will be presented to the clinician in an easy-to-understand
report and will include longitudinal results, con dence estimates, and normative data to enable comparisons
both within and between patients. The system will include provision to interface with electronic medical records
(EMRs).
Accurate functional assessment is a crucial component in the e ective treatment of chronic pain. The
proposed approach will supplement existing methods for assessing patient function (e.g., PROs) by providing
novel and highly complementary information for a more complete (and often unobserved) picture of the impact of
chronic pain on patient function. KnowPain measures will provide important data on the practical consequences
of pain and on treatment ecacy. The impact of chronic pain on daily life is a primary concern for patients;
patients assign great value to pain interventions that improve their ability to participate in normal daily activities.
The proposed KnowPain system will provide currently unavailable objective data to facilitate informed and
e ective pain management decisions, leading to: (1) reduced functional impairment, increased mobility, and
improved quality-of-life; (2) de-emphasis on medications, particularly opioids; and (3) reduced disability and
associated healthcare costs, including worker's compensation.
