It is a piece of cake to diagnose a fracture: An X-ray can detect a fracture in even the smallest of a person’s more than 200 bones. In contrast, pain diagnosis and subsequent pain management is still a huge challenge. Pain is a highly complex phenomenon that, until now, has defied objectifiable assessment.
Pain diagnosis: An unsolved challenge
The standard question at the doctor’s office is “On a scale of 1 to 10, how bad is your pain?”. In fact, as of today this simple Numeric Rating Scale (NRS) for recording subjectively perceived pain is the gold-standard in pain diagnosis and management. The problem is obvious: What will be the assessment of a child who has had little experience of pain? How will a physician assess the testimony of a military member who is trained to “grit his teeth”?
Phantom limb pain (in case of loss of a body part) also indicates that pain or pain sensation is primarily a neurological phenomenon. The symptoms (and neurological patterns) of acute and chronic pain also differ: While high blood pressure or sweating can be observed in acute pain, this is not (any longer) true for chronic pain: The body is already in “survival mode” and the pain changes its character.
Physicians (sometimes – not always) resort to other methods to get a better idea of the patient’s pain condition. For example, they may resort to the Kellgren-Lawrence_Grade (KLG) system for assessing the severity of arthritic pain: it is a standard scoring system that takes into account the extent of structural damage and missing cartilage. However, data from the National Institutes of Health found that when Patients of Color use this system to report their pain, it results in a pain score lower than what they are truly experiencing. It is likely that the system itself was subject to bias when it was first developed as it is based primarily on data from white British patients, leading to greater inaccuracies in other demographics.
In fact, those who talk to physicians learn about a number of other methods in an attempt to better understand their patient’s pain. Nevertheless, pain diagnosis still remains an immense challenge. This challenge is also reflected in the fact that one of the major government institutions in the U.S. is allocating over $100 million for Pain Diagnosis 4.0.
Pain therapy: The market
The relevance of accurate pain diagnosis is undoubtedly widely underestimated: Efficient pain diagnosis and treatment is important for approximately 120 million (sic!) patients in the USA alone who suffer from chronic pain. In Europe, there are more than 100 million additional patients. The causes of pain are multiple: Neuropathic pain, osteoarthritis, rheumatoid arthritis, musculoskeletal pain, low back pain, migraine and the like. Some observers even suggest that inadequate pain management (in this case, primarily mismedication) contributes to the opioid crisis in the U.S., which claims tens of thousands of lives annually.
In terms of cost, the healthcare market around pain management is as follows: Recent studies have estimated that the total cost to the US Healthcare system up to $635B annually. Treatment is provided in hospitals, nursing homes, physicians’ offices and over 7500 pain clinics in the USA.
PainQx: An objectifive assessment of pain using AI
The start-up PainQx (website: www.painqx.com) has developed a series of AI-powered algorithms that can evaluate the sensation of pain based on neurological brain activity from EEG data. An objective, neurological based biomarker for pain will establish a foundation for more effective pain management practices.
The starting point is the measurement of neurological brain activity (brain EEG), for which a commercially available headset as shown in the below picture is sufficient. Devices with retail prices starting at $1,000 already provide sufficient EEG recording (see also EEG headsets). The recording itself takes a few minutes.
The evaluation is based on a AI algorithms developed by PainQx over several years by an experienced team of Data Scientists and Neuroscientists. The development is based on around 25,000 EEG recordings that have been built up at the NYU School of Medicine over a period of 40 years in one of the largest databases of its kind; the company PainQx has acquired the exclusive rights to both the data and the analyses. Over 9,000 unique features have been extracted in the process over 40 years, with hundreds more such features identified over the course of development over the past few years. PainQx has also added to the NYU EEG database through a series of clinical studies, including multiple in partnership with the US National Institutes of Health (NIH).
The startup has already been in close contact with the US Food and Drug Administration (FDA) to prepare for upcoming validation studies, with commercial launch planned for late-2022. The focus for the first practical application is on selected causes of pain: Neuropathic pain, osteoarthritis, rheumatoid arthritis, musculoskeletal pain, low back pain. Once this phase of development is complete, PainQx plans to expand its method to other causes of pain.
In a conversation I had with Founder and CEO, Frank A. Minella in early June (via video call), Frank told me, “My vision for the company goes much further. Our team looks to add more data inputs and modalities for more accurate pain diagnosis.” He said “Blood-based biomarkers, data from sleep sensors, heart rate, and the like are promising datasets that can be used in and in conjunction with our algorithms and our overall platform development.”
Since the team has developed deep expertise in identifying patterns of neurological brain activity associated with disease, it is conceivable that this expertise could be applied to other conditions as well: Diagnosis of depression, anxiety or even post-traumatic stress disorder.
The story of PainQx began in 2015: for about two and a half years, the founding team worked (in self-funding mode) to establish a methodological R&D pipeline, understand the state of ongoing pain research, partner with key experts in the field, and develop a strategy to ensure the PainQx technology will be commercially successful. In the next phase, PainQx was competitively awarded over $3.2 million U.S. dollars in funding from U.S. two government institutions: the National Institutes on Health (NIH) and the Defense Health Agency (DHA) for the objectifiable pain diagnosis project development. As explained earlier, PainQx addresses one of the key challenges in healthcare management. Currently PainQx is negotiating with investors in the U.S. and Europe for Series A funding to help prepare for FDA regulatory clearances and for commercial launch.
Good luck to you and your team, Frank!