Blog | 9/21/2022
Digitalization in Pain Management: A Painless Effort?
By Dominic Bachmann and Dr. Holger Müller
Key Takeaways
- Pain results in significant and widespread disability and suffering. ~70% of patients in the emergency department suffer pain acutely, and up to 50M of the US population experience chronically
- Pain is multi-factorial, with both sensory and emotional components. Despite the recognition of the multi-factorial nature of pain, pharmacotherapy remains the mainstay therapy in pain management with NSAIDs and opioids being the dominant MoAs
- However, alternative pain management strategies such as movement- and behavioral based techniques, as well as mind-body interaction have long been applied in pain management
- The emergence of connected devices will support a transition of these alternative strategies into the digital environment
- While a clear winner for non-pharmacological pain management strategy has not emerged, musculoskeletal-associated pain is mostly treated with movement-based therapies while multi-sensory pain sentiments require also multi-factorial treatment approaches
Pain as a Multi-Sensory Indication
Pain is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. It is broadly categorized into nociceptive pain, which develops because of receptor activation by a specific stimulus such as a broken bone or burnt tissue, and neuropathic pain, which arises from disease or malfunctioning of the nervous system without any specific outside stimulus. Although nociceptive pain is more commonly associated with a short duration and resolves when the injured tissue heals, both types of pain can be of acute (<3 months) or chronic in nature (≥3 months).
Given that 50 million people in the US suffer from chronic pain, it is unsurprising that chronic pain is one of the most common reasons why patients seek medical attention. Prevalence of chronic pain is only expected to increase due to an aging society and lifestyle changes that will increase the incidence of chronic conditions that cause pain, like osteoarthritis or sarcopenia. Typically, chronic pain is treated in an outpatient setting. Acute pain, meanwhile, is commonly treated in hospitals and is reported in over 70% of patients admitted to the emergency department. In both cases, pain is associated with significant medical, emotional, and socioeconomic burdens, amounting to hundreds of billions of dollars in direct medical costs, lost productivity, and disability insurance. In a much-cited article, the US Journal of Pain estimated that the total annual cost of chronic pain management ranged between $560 to $636B annually.
Non-Pharmacological Approach in Pain Management
From the 1970s to 1990s, a growing understanding of the underlying mechanisms that cause pain and the introduction of novel pain medications led many to believe that the medical community and pharmaceutical companies would be able to dramatically reduce the incidence of uncontrolled pain. Unfortunately, the efficacy of these interventions was less than hoped for and opioid-based treatments were partially misused, contributing to an opioid crises. Consequently, multiple institutions, like the National Academy of Medicines or NIH’s Strategy for Pain are promoting a shift from pharmacology-based approaches to a more patient-centric, collaborative care-based approach, that emphasizes the patient’s essential role in the management of his or her pain-related condition. Several non-pharmacological pain management strategies are available and have a well-documented history as effective pain management approach. These can be broadly classified into behavioral- and movement-based approaches as well as mind-body interventions (Figure 1).
Widespread use of these alternative, non-pharmacological treatment options have been limited however, due to lack of payer coverage of these services, limited availability of providers, and lack of awareness and/or acceptance amongst physicians.
Emergence of Digital Solutions in Pain Management
Digital tools can be leveraged to address the shortcomings of these established, non-pharmacological treatment approaches for pain management, given the ubiquity of connected devices and the increasing digitalization of healthcare services and systems. In recent years, a number of these approaches have reached the commercial stage and are now available to patients (Figure 2).
These solutions digitize the non-pharmacological pain management approaches outlined in the previous graphic (mind-body, movement-based, and behavioral approaches). In doing so, they improve access to these interventions either by leveraging telemedicine or by removing the human provider entirely. For example, Kaia’s solution is software only and leverages mobile phones and visualization technologies to guide patients through their exercises. Omada’s solution on the other hand builds on a telemedicine platform that removes the geographical barrier between in-person therapists and the patients, augmented with visualization technologies that track the progress on motion range in patients. Both approaches place more responsibility for treatment with the patient, a key principle of the National Institutes of Health (NIH) national pain strategy.
Developers of these solutions are rightly focused on generating compelling evidence to demonstrate clinical effectiveness and ensuring robust market access through payer reimbursement. Kaia, for example, designed its Rise-uP clinical trial as a randomized two-arm study involving 1,245 patients and following its proof of efficacy, the innovation office of the Federal Joint Committee (G-BA) suggested for Rise-uP to be included in the reimbursable service portfolio. As we discussed in an earlier Health Advances blog, robust evidence generation can translate into higher pricing potential at least in Germany following the introduction of the Digital Healthcare Act, short DVG.
Modes of Action: Correlation but No Clear Winner
The various digitized non-pharmacological pain management approaches lend themselves to different use cases (Figure 3). Developers of digital pain management solutions should take note and align their approach (e.g., movement-based, behavioral, mind-body) with the type of pain that is being addressed. Unsurprisingly, musculoskeletal pain is primarily addressed through movement-based approaches, replacing physiotherapy with digital solutions. Complex pain conditions with multifactorial causes (e.g., migraine or fibromyalgia) rely on approaches that stimulate physical- and neurological aspects simultaneously. Sedation and analgesia have been applied more commonly for use in acute pain management. These solutions rely heavily on body-mind interactions like distraction and hypnosis, to compete with the pain sentiment for the patient’s mental capacity and thus lend themselves more to acute pain management.
When correlating underlying non-pharmacological treatment strategies with the targeted types of pain, no clear winner can be identified. Current evidence suggests that each treatment strategy is specifically suited for a selected patient population. Developers therefore need to link their treatment approach with the targeted patient population and define a coherent evidence generation strategy. To further minimize the technology risk, developers should also consider the complexity of the underlying technology. Omada for example employs a telemedicine solution to connect patients with actual therapists, Kaia takes a more digitized approach, leveraging visualization technologies to eventually replace the in-person therapist altogether, clearly increasing the technical risk for the developer and requiring a comprehensive evidence base, which is obvious from Kaia’s 3,000 patient programs.
References
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8255155/
https://aixr.org/insights/digital-therapeutics-a-modern-solution-to-chronic-pain-management/
https://pharmaphorum.com/news/trial-finds-orion-digital-therapeutic-helps-chronic-pain-sufferers/
https://www.chiefhealthcareexecutive.com/view/fda-approves-digital-health-app-chronic-pain
https://clinicaltrials.gov/ct2/show/NCT04225884
https://www.frontiersin.org/articles/10.3389/fpubh.2021.779328/full
https://pubmed.ncbi.nlm.nih.gov/33353407/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4590163/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5732548/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4590076/
https://nam.edu/programs/action-collaborative-on-countering-the-u-s-opioid-epidemic/
https://bmcprimcare.biomedcentral.com/articles/10.1186/s12875-017-0608-2
https://www.nga.org/wp-content/uploads/2020/08/NGA_PainManagement.pdf
https://pubmed.ncbi.nlm.nih.gov/15745617/
https://www.sciencedirect.com/science/article/abs/pii/S0140673600021620
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Dominic Bachmann is a Senior Analyst based in the Zug office with experience in market-, product- and portfolio assessments for several therapeutic areas across biopharma, medtech, diagnostics, and digital health.
Dr. Holger Müller is a Vice President and leads Health Advances’ European Office. Holger works extensively with industry clients from the biopharmaceutical- and digital technologies sectors and with investors on buy- and sell side assessments.