A Randomized Controlled Trial of a Community-Based Chronic Pain Self-Management Program in West Virginia Chronic pain (CP) affects 1 in 3 US adults and costs up to $635 billion annually in medical costs and lost work productivity. The impact of CP is worse in people with both CP and comorbid chronic diseases such as arthritis, diabetes, and heart disease. Use of opioid medications for CP has risen in the US, and opioid overdose deaths have quadrupled, yet with no overall change in pain. Although one-third of US adults have CP, there is a lack of affordable, non- pharmacological, evidence-based, community-delivered interventions for people with CP. Thus, there is a vital need to rigorously test more interventions that can be brought to scale and widely disseminated in the US. One program, the Chronic Pain Self-Management Program (CPSMP), provides short-term improvements in pain but its long-term effects (i.e., at 1 year) have not been evaluated. This study will examine the long-term effects of CPSMP in the medically underserved state of West Virginia (WV). With one of the worst health profiles in the US, WV has the highest rates of arthritis, diabetes, heart disease, and drug overdose deaths, and therefore has a compelling need for the CPSMP. The objectives of this community-engaged, randomized, wait-list controlled study are to: 1) determine the short- (12 and 24 weeks) and long-term (52 weeks) effectiveness of the 6-week CPSMP in adults with CP in WV; 2) evaluate the Reach (number of participants, completers), Effectiveness (outcomes), Adoption (number of sites, leaders, trainings), Implementation (fidelity), and Maintenance (satisfaction, continuation) of CPSMP using the RE-AIM Framework; and 3) disseminate the results to key stakeholders including evidence-based organizations, public health practitioners/researchers, and healthcare providers. The study will enroll 128 participants in 16 workshops at 8 community-based sites in 2 counties in WV, Greenbrier (rural) and Wood (urban). Participants will attend free, 2.5-hour weekly sessions for 6 weeks. Two trained leaders will facilitate group discussions on managing pain, emotions, depression, fatigue, and sleep; proper exercise, nutrition, and medication use; weight management; strategies for effective communication with healthcare professionals; evaluating treatments; and pacing/planning. Self-reported, performance-based, and physiological data will be collected at baseline and 12, 24, and 52 weeks after the intervention ends. The primary outcomes are pain (severity, quality, interference, medication use), mental health (mood, anxiety, catastrophizing), function (self-efficacy, coping, health-related quality of life, sleep, fatigue, communication, physical activity), healthcare utilization, missed work days, and gait speed. Secondary outcomes include A1C and cholesterol levels, blood pressure, and body mass index.
A Randomized Controlled Trial of a Community-Based Chronic Pain Self-Management Program in West Virginia The proposed study addresses a critical gap in the management of people with chronic pain and will determine if the Chronic Pain Self-Management Program has long-term benefits. Given the lack of programs to address chronic pain, the investigation of a safe, sustainable non-pharmacological intervention, which may not only alleviate pain symptoms but address associated co-morbidities, is clearly warranted in medically underserved West Virginia. If the findings of the proposed study are positive for the intervention's long-term benefits, this study can help support the development of a public health infrastructure to widely disseminate the program, and contribute to reducing the individual, societal, and economic burden associated with chronic pain.
