Millions of Americans live with acute and chronic pain that affects every aspect of their lives. Pain by itself is an important marker of how a patient is feeling and indicates what kind of medical intervention might be necessary. The healthcare industry needs a clinically acceptable way to objectively measure pain and since pain is a very complex mixture of biochemistry and genetics and it’s unlikely that a laboratory test that directly quantifies pain will be developed.
Doctors have been using questionnaires and subjective responses including, the answer to the popular question, ‘What is your pain on a scale of 0 to 10?’ Unfortunately, each person’s pain tolerance and perception are different. Responses can be exaggerated or underplayed, pain can vary in how it is experienced or the conditions it is caused by…not to mention, adults and children can experience pain differently. It’s ultimately up to the clinician to determine the level of pain. To further complicate the pathology, clinicians may treat pain differently when it is a symptom versus when it becomes the primary pathology. One clinically actionable solution is to indirectly quantify the effects of pain using motion as a functional biomarker.
There is no question that a multi diagnostic strategy is always the best when applied to any disease. Healthcare professionals have now found that assessing a patient’s functional movements including balance, gait, and range of motion is more important than a subjective pain-based response alone. New tools have made it possible to use motion as a functional biomarker and endpoint for many treatments where the pain is involved. The ability to assess sudden or gradual changes in movement can be a vital factor in the early diagnosis, treatment, and management of a wide number of painful health issues.
Can pain be quantified? A new clinical trial showcases landmark progress in objective pain measurement.
Diagnostic and therapeutic challenges overly rely on self-reporting and the paucity of biologically-based objective methodologies. Non-addiction medicine rehabilitation specialists are likely to adjust medications based on patients’ complaints and justify increasing dosages, secondary to inadequate pain control, attributing such scenarios to the development of tolerance or progression of the disease. Without objective signs of non-adherence, the clinician may increase dosage accordingly by the absence of aberrant behavior. This does not rule out the presence of tolerance, physical dependence, addiction or drug diversion. Patient behavioral variability renders subjective analyses unreliable, and well-informed addicted patients can avoid these indirect indicators until the addiction severity overpowers self-control.
There are many treatments for pain and the ability to quantify the patient’s functional status can aid the clinician in the determination and management of their pain. A recent clinical study led by medical director Gladstone C. McDowell II, M.D., of Integrated Pain Solutions is being conducted to understand the link between functional motion and incapacitating back and leg pain in patients being treated with Nevro Corp. HFX Spinal Cord Stimulation. Dr. McDowell’s work was chosen as the Best Spinal Cord Stimulation Abstract winner at the 2022 American Society of Pain and Neuroscience (ASPN) annual Conference.
The year-long study involved 25 adult patients who were implanted with the Nevro Senza® Spinal Cord Stimulator (“SCS”). Patients’ functional status were assessed using the Oswestry Disability Index (“ODI”), a standard patient self-reporting instrument. A clinical sensor-based motion system was also employed to systematically measure functional motion and cognition in patients to warrant the use of a permanent stimulation device. Strategically placed sensors allow for the noninvasive capture of normal and pathological motion data to identify, assess, and adequately transform patient motion patterns including ambulation, balance, symmetry, range of motion, and cognition.
Inside the Clinical Study: What doctors observed.
The study was able to demonstrate there was a significant disparity between the patient’s perception, their ODI score, and the objective measurement of their function, analyzed by the sensors.
Overall, patients who received the SCS system had a significant and measurable improvement in functional motion (gait and overall balance). The few patients that were ultimately not ideal candidates for SCS implantation demonstrated significant dysfunction pre-implantation that may have indicated a lack of functional improvement post-implantation. In addition, the study confirmed that the testing and measurement of movement-based functional biomarkers provided objective and actionable analyses with greater accuracy, augmenting traditional subjective pre- and post-surgical pain assessment protocols.
AI, ML, and Sensor Technology for Pain Measurement and Management
Advancements in AI, ML, and sensor technology are finding their place in the healthcare industry. These technologies are being used to quantify unmeasurable parameters like pain; objectify physical, surgical, pharmacological, and cognitive therapies; and as a real-time biofeedback therapeutic tool that defocuses patients’ attention on the pain and discomfort and redirects their focus on their functional performance.
The development of laboratory-grade, portable technologies that provide clinically relevant information regardless of the patient’s location are critical since pain is a ubiquitous problem and access to the appropriate specialist is not equivalent across the country.
The ability to quantify, measure and manage the effects of pain is a significant advancement in treating pain-related pathologies and can improve the lives of millions living with pain anytime, anywhere.
Patients, practitioners and payers will all benefit.
About Frank Fornari, Ph.D.
Frank Fornari, Ph.D., is a life sciences consultant, educator and entrepreneur with extensive experience in pharmaceutical, basic scientific research, clinical medicine, toxicology, chemistry, and drug development. He is also chairman and founder of BioMecha leading-edge biotechnology company that develops and distributes real-time motion analytics and artificial intelligence/machine learning solutions, including BioMech Lab™ and Coretex™ that quantify and improve outcomes in healthcare, sports/wellness and industrial sectors. For more information, visit www.biomech.us.