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 significant 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 effort 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, confidence 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 effective 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 efficacy. 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 effective 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.
Public Health Relevance Statement: Project Narrative Products resulting from this grant will improve evaluation and treatment of chronic pain through more accurate assessment of the impact of chronic pain on daily physical functioning and on activities of daily living. The ability to objectively determine the functional impact of pain will aid in selecting appropriate treatment interventions and in judging their effectiveness, leading to more informed and ecacious treatment. Additionally, the KnowPain instrument can be used in clinical trials for new pain treatments and other interventions.
NIH Spending Category: Bioengineering; Chronic Pain; Clinical Research; Neurosciences; Pain Research; Physical Rehabilitation; Rehabilitation
Project Terms: Activities of Daily Living; analytical method; Assessment tool; base; Biometry; chronic pain; chronic pain patient; clinical pain; Clinical Research; Clinical Trials; cohort; Communication; Complement; Complex; Computer software; Computerized Medical Record; cost; Custom; Data; Dementia; design; Devices; disability; effective therapy; Effectiveness; Evaluation; experience; Freedom; functional disability; Grant; Health Care Costs; Heart Diseases; Heart Rate; heart rate variability; improved; improved outcome; Individual; innovation; instrument; Intervention; kinematics; Language; Letters; Life; light weight; Literature; Malignant Neoplasms; Measurement; Measures; Methodology; Methods; Modeling; Motion; Nature; novel; Opioid; Pain; Pain intensity; Pain management; Pain Measurement; Pathology; Patient Outcomes Assessments; Patient Self-Report; Patients; Pharmaceutical Preparations; Phase; phase 2 testing; Physical Function; Physiological; Primary Health Care; Process; profiles in patients; Property; prototype; Psychometrics; Quality of life; Reporting; Research; response; Rotation; sensor technology; Skin; Small Business Innovation Research Grant; Statistical Models; Surface; System; Technology; Temperature; theories; tool; trait; Translations; Treatment Efficacy; usability; Work; Workers' Compensation; Wrist
