Pivoting to virtual delivery for managing chronic pain with nonpharmacological treatments: implications for pragmatic research

Coronavirus disease 2019 (COVID-19) created rapid disruptions throughout healthcare. Before the pandemic, chronic pain was the leading cause of disability worldwide,1 and one of the most common reasons for healthcare visits.[18; 31; 70; 71] COVID-related restrictions interrupted in-person care and have had other detrimental effects for individuals with chronic pain. Co-occurring mental health conditions are common among persons with chronic pain,[40; 64] and may be intensified by the social isolation and psychological consequences of COVID-19.[35; 74] Chronic pain is more prevalent in older adults[19] whose activities are most restricted. Pandemic-related disruptions present unique challenges for individuals with chronic pain and may have enduring consequences.

Pain care has been undergoing a transformation to increase focus on nonpharmacological treatments (NPTs).[58] Recommended NPTs for chronic pain include exercise, acupuncture, manipulation, mindfulness, cognitive-behavioral therapy (CBT), and other approaches.[69; 75] Although guidelines recommend NPTs, implementation into routine care has lagged.[29] Overuse of imaging, interventional pain procedures, and medications, particularly opioid therapy, continues to characterize chronic pain care.[43] The considerable gap between guidelines and practice has motivated pragmatic research studying implementation in “real-world” settings. Implementation of NPTs was difficult before COVID-19. The pandemic has imposed additional challenges. COVID-19 could result in losing ground on efforts to narrow the pain management evidence-practice gap, raising concerns that overreliance on opioids and other low value care will increase.[53,41]

Pivoting to Virtual Pain Management – The Need for Pragmatic Research

Virtual delivery encompasses all the ways providers interact synchronously or asynchronously with patients using technology, including videoconferencing, audio-only communication, mobile apps, and remote health monitoring.[25] There was pre-pandemic interest in virtual delivery as a strategy to overcome the pain management evidence-practice gap, but implementation was sluggish.[18] Thus while the pivot to virtual delivery has been disruptive, it presents unique opportunities to address key questions via ongoing pragmatic research. The National Institutes of Health (NIH)-Department of Defense (DoD)-Department of Veterans Affairs (VA) Pain Management Collaboratory (PMC) supports 11 large, multi-site pragmatic clinical trials in military and VA health systems.[45] The PMC pragmatic trials examine a spectrum of NPTs. COVID-19 disruptions have posed a variety of challenges and opportunities for these studies.[14]

Pragmatic studies evaluate the effects of treatment provided under usual clinical circumstances.[12; 79] Relative to research evaluating treatment efficacy under controlled conditions, pragmatic studies permit greater flexibility in several domains, including intervention delivery. Thus, ongoing pragmatic trials may more readily accommodate the transition to virtual delivery. PMC investigators, as an interactive research group, have identified important challenges and opportunities related to the shift to virtual delivery of NPTs. Some issues are common across studies, while others relate to characteristics of specific NPTs. Herein, PMC investigators highlight issues arising from the pivot to virtual delivery, and identify research gaps to be addressed to help ensure that virtual delivery is part of improved pain management in a post-pandemic future.

Cross-Cutting Issues Related to Virtual Delivery of Nonpharmacological Pain Treatments

Although PMC investigators are examining many NPTs, there are cross-cutting challenges and knowledge gaps related to virtual delivery. These issues are summarized in Table 1 and described below.

TABLE 1.

Summary of cross-cutting issues identified by the Pain Management Collaboratory investigators and the corresponding knowledge gap that can be addressed through pragmatic research.

Cross-Cutting Issue Related to Virtual Delivery of NPTs	Knowledge Gaps Addressable by Pragmatic Research
Provider Training	Quantify and compare with in-person care the ability to form patient-provider therapeutic alliances Document amount and type of provider training required to achieve effective alliance with patient using virtual delivery
Patient Preferences	Examine patient preferences for mode and technologies for virtual delivery Document differences in preference based on race/ethnicity, age, rurality, and other factors Identify strategies to engage patients and providers in shared decision-making regarding virtual delivery
Privacy	Develop patient education strategies to facilitate informed decision-making around privacy and security concerns
Implementation and Sustainability	Evaluate COVID-19- necessitated implementation efforts using comprehensive, theory-based frameworks Develop strategies to sustain and scale virtual delivery as in-person care resumes
Risk of Exacerbating Co-Occurring Conditions	Document and evaluate for accuracy assessment procedures to identify risk for acute exacerbations of mental or physical health conditions
Multimodal Care	Examine procedures for communication and coordination of care within and between a patient and multiple providers. Develop and evaluate strategies to integrate virtual care into multimodal pathways (e.g., stepped care delivery models)
Risk of Exacerbating Health Disparities	Evaluate accessibility of virtual delivery options among diverse patient populations Develop and evaluate solutions to overcome access barriers

Provider Training:

A good patient – provider therapeutic alliance encompassing mutual trust and empathy is a cornerstone patient-centered and effective NPTs.[6; 28] The provider skills necessary to achieve an effective alliance may differ between virtual and in-person delivery. A limited number of studies suggest good therapeutic alliance can be achieved virtually,[37; 39; 77] however this research focuses on psychotherapy for mental health diagnoses. Little is known about the development of effective alliances across a broader range of patients and providers. Research is needed to identify facilitators of effective therapeutic alliances for virtual delivery using different technologies (e.g., phone, videoconference, etc.).[10] Understanding the amount and type of provider training, and determining optimal strategies to achieve effective therapeutic alliances are research questions that can help ensure providers’ ability to deliver effective NPTs virtually.

Patient Preference.

The sudden emergence of COVID-19 caused healthcare systems to pivot to virtual delivery irrespective of patients’ preferences. As the pandemic wanes, decisions to provide care virtually or in-person should increasingly be shared with patients. Pre-COVID research on patient preferences for virtual versus in-person primary care visits revealed differences based on patients’ age, race/ethnicity, and socioeconomic factors.[66] Because patient engagement and motivation are important for effective NPTs, failure to consider patient preferences could adversely impact care. Further research on preferences is needed to inform strategies for informed decision-making beyond the COVID-19 pandemic.

Privacy:

The U.S. Department of Health and Human Services issued guidance for telehealth during the COVID-19 pandemic, authorizing any non-public-facing remote delivery option available to communicate with patients without penalties for HIPAA noncompliance.[73] Yet patients may have privacy concerns around virtual delivery arising from personal circumstances, such as lack of trust in health systems or living arrangements that do not easily accommodate sensitive conversations. Privacy concerns may make patients less willing to participate in virtual delivery or to share important information out of concern for inappropriate disclosure, discrimination or stigma. Privacy concerns are a barrier that need to be addressed to sustain virtual delivery.

Implementation and Sustainability:

While the rapid pivot to virtual delivery was unplanned, the ability to sustain this option into the future requires preparation. Studies before COVID-19 found virtual delivery especially difficult to implement, scale and sustain; with high rates of non-adoption and abandonment despite intensive efforts and enthusiasm.[34] Frameworks including the non-adoption, abandonment, scale-up, spread, and sustainability and user-centered design can provide organizing frameworks for developing, implementing and evaluating technology-based strategies.[33] Using theory-based frameworks to plan NPT virtual delivery will be invaluable to sustain use as in-person care resumes.

Risk of Exacerbating Co-Occurring Conditions:

Chronic pain is associated with high rates of mental health conditions including depression, post-traumatic stress disorder, substance use disorders, suicidal ideation and attempts.[8; 36; 44] Pandemic-related stressors may exacerbate these conditions. The ability to recognize warning signs of mental health crises is an essential task for providers working with patients with chronic pain. Use of NPTs may reduce risk for adverse outcomes from these comorbid conditions,[54] but the impact of transitioning to virtual delivery is unknown. Additional training and new assessment procedures are needed to help providers identify risk factors when providing care virtually and to shift to in-person care when required for patient safety. Protocols to address patients identified as a threat to self or others during virtual delivery should be clarified.

Multimodal Care:

The complex, biopsychosocial nature of chronic pain is best managed with multimodal care that uses combinations of medical management and multiple NPTs.[22] Evidence is clear that no single NPT is superior for all patients with chronic pain, and multimodal approaches are more effective.[42; 62] Multimodal care requires communication and coordination among and between providers and patients to provide the appropriate treatment tailored to a patient’s circumstances, and to modify care based on responsiveness.[46] Multimodal pain pathways pre-COVID were rare, with the VA health system leading the development of delivery models.[9] Strategies to integrate virtual delivery are needed to sustain efforts to implement multimodal pain models post-COVID.

Risk of Exacerbating Health Disparities:

Disparities in the experience and treatment of pain based on poverty, rurality, and race/ethnicity were pre-COVID concerns identified by the National Pain Strategy and other efforts.[15; 38; 55] Given the overrepresentation of chronic pain among poor, rural, and racially/ethnically diverse populations, the potential to deepen disparities in the pivot to virtual delivery must be considered. For example, chronic pain among individuals in the lowest income quartile in the U.S. is more than twice the population average; Black/African Americans and Hispanic/Latinx in the U.S. are more likely to report severe pain present most of the time, yet individuals in these groups are less likely to receive NPTs.[40; 57; 67; 80] People in rural communities, particularly with low household incomes, are also more likely to report chronic pain, more likely to receive opioids, and less likely to receive NPTs.[11; 23; 30; 65]

While virtual delivery has the potential to expand access and help alleviate disparities; evidence before and during COVID-19 suggests it may have the opposite effect.[7; 24; 59; 78] Both urban and rural underserved communities face financial and resource challenges described as a “digital divide” that must be overcome if virtual delivery can be part of the solution to health disparities. Of particular concern are access to, and comfort with technology, availability of high-speed internet, and trust in health systems.[21; 59] Preliminary reports on virtual delivery during COVID raise concerns that non-White or lower income persons are less likely to receive virtual care.[24; 49; 84] Pragmatic research should examine strategies to mitigate the digital divide for NPTs to avoid the unintended consequence of deepening pain management disparities.

Issues Related to Virtual Delivery of Specific Nonpharmacological Pain Treatments

The pivot to virtual delivery raises additional considerations for specific NPTs. An important distinction occurs between NPTs that rely to varying degrees on physical touch and care that does not use physical touch as outlined below.

Touch-Based Therapies

Evidence-based NPTs for chronic pain that use physical touch are used by chiropractors, physical therapists, acupuncturists and massage therapists.[75] These providers also rely on touch for assessment, clinical decision-making, and patient engagement. Virtual delivery alters or removes these sources of information.

Prior to COVID-19 there was little evidence on the effectiveness of touch-based therapies provided virtually. Most studies involved physical therapy. With respect to assessment, limited research supports the concurrent validity of pain intensity and range of motion assessments conducted in-person or virtually.[50] One study of physical therapists and patients with back pain found good diagnostic agreement between in-person and assessment using videoconferencing.[63] A modest body of literature suggests the outcomes of physical therapy provided virtually are at least equal to in-person treatment; however, most studies examined post-surgical care (e.g., joint arthroplasty that typically places less emphasis on hands-on treatment.[16] Other studies examined virtual delivery as an adjunct to in-person care, which likely reduces some challenges arising from entirely virtual delivery.[16; 81]

Although research on virtual delivery of touch-based NPTs is sparse, there are important lessons to inform future efforts. A study from the United Kingdom implemented a phone-based, physical therapy assessment and advice intervention for patients with musculoskeletal pain and found outcomes equivalent to in-person care.[72] Phone-based care was acceptable to patients, although it was preferred as an adjunct, not a replacement, for in-person interactions.[61] Qualitative studies examining virtual delivery of NPTs for chronic pain suggest that patients prefer phone-based virtual delivery to alternatives such as videoconferencing or internet-based care,[17; 83] but it is unclear if these findings represent current preferences or reflect outdated attitudes about older technology. A COVID-related adaptation of chiropractic care to virtual delivery using videoconferencing in work sites clinics reported that patients were satisfied with the visits.[32] A small number of studies examine adaptations of hands-on therapies for virtual delivery, such as instructing patients about self-massage, self-mobilization, and manual stimulation of acupressure points.[5; 13; 60]

The COVID-induced pivot to virtual delivery illustrates the need for evidence evaluating touch-based NPTs adapted for virtual delivery. Studies should evaluate effectiveness relative to in-person care and other virtual options with additional patient-centered outcomes including adherence, satisfaction, and side effects. There is a need to examine different modes of virtual delivery and opportunities to develop hybrid in-person and virtual protocols. There is also an opportunity to re-evaluate the role of touch-based procedures for providers who have historically relied on these techniques. For example, chiropractic care is often perceived as synonymous with spinal manipulation, despite its multimodal scope of practice.[82] Virtual delivery necessitates greater emphasis on other components (e.g., education and self-management instruction).[32] Adapting touch-based NPTs for virtual delivery will require additional provider training and curricular changes in education programs.

Finally, the payment environment was an important pre-COVID-19 barrier to virtual delivery of touch-based NPTs. Medicare, Medicaid, and commercial insurers restricted or denied reimbursement of virtual visits provided by chiropractors, physical therapists, or other providers who utilize touch-based treatments. Modifications and waivers were granted in response to COVID-19, but not all NPT providers were included, and the sustainability of these changes is uncertain.[2; 3] Pragmatic research has a unique opportunity to provide evidence to inform future policy determinations and payment models.

Non-Touch-Based Therapies

Several evidence-based NPTs do not involve physical touch including psychological therapies, mindfulness-based interventions, and self-management programs including yoga or other exercise regimens.[75] The absence of touch alleviates some challenges to the adaptation for virtual delivery, but important considerations remain.

A body of literature existed pre-COVID on virtual delivery of non-touch-based NPTs,[56; 76] however most studies examined asynchronous, self-guided internet-, or app-based delivery with limited provider interaction. Few studies evaluated synchronous, phone-based, or videoconferencing delivery options.[76] Systematic reviews of these studies identify reductions in pain, disability, and psychological distress of modest magnitude favoring virtual delivery relative to control conditions for patients with chronic pain, with no differences between virtual and in-person delivery of the same NPT.[4; 51; 76] A recent trial from the VA health system found better outcomes for patients with chronic pain and a mood disorder from virtual delivery of psychological NPTs provided with intermittent provider contact versus no contact.[48] Patient satisfaction and sense of being cared for were greater for those receiving provider contact.[52]

Despite supporting evidence, virtual delivery of non-touch NPTs was rare before COVID-19, due to several important barriers. Patient perceptions and awareness of virtual delivery options for NPTs are often low.[27] Without the benefit of in-person provider support, the cognitive demands of interacting with education materials, workbooks, and other information associated with psychological therapies such as CBT can be challenging for many patients. In addition, many psychological therapies for chronic pain including CBT, mindfulness, yoga and exercise therapies, are often provided to groups of patients,[47] a circumstance that may be difficult to replicate in a virtual format.

Disruptions from COVID-19 provide opportunities to address important research gaps related to non-touch NPTs. A key consideration is the optimal balance of provider contact versus patient-directed, self-management, which may differ for individual patients. NPTs delivered using internet-based or other virtual resources without provider contact are effective, but effect sizes are small and inconsistent.[26] It remains unclear to what extent provider guidance and contact enhance outcomes.[20] Self-management approaches are attractive as a strategy to overcome shortages of behavioral health providers and overcome the stigma and costs that may accompany provider-led psychological treatment.[68] Group-based delivery of exercise and psychological therapies is a common strategy to facilitate patient motivation and compliance while reducing provider time demands. Investigations are needed into virtual strategies for group-based care or alternative approaches to help motivate and engage patients. Research is also needed to understand the optimal content and timing of the self-directed work required of patients during virtual delivery to avoid cognitive overload, particularly for patients who are older or with lower health or digital literacy.

Conclusions

Virtual delivery of NPTs for pain management has been promoted and tried on a small scale for many years. The COVID-19 pandemic forced wide-scale implementation. As a multi-disciplinary group of researchers conducting pragmatic studies of NPTs, the NIH-DoD-VA PMC was well-positioned to respond to the rapid pivot to virtual delivery and consider opportunities to inform the future of virtual delivery of nonpharmacologic pain care. The post-COVID-19 future of virtual delivery of NPTs is uncertain. Making NPTs available across an array of delivery modes can help reduce over-reliance on pain medications, promote patient-centered care and may be an important strategy to narrow the evidence-practice gap around the use of nonpharmacological pain treatments.