Supported biopsychosocial self-management for back-related leg pain: a randomized feasibility study integrating a whole person perspective.
Brent Leininger, Roni Evans, Carol M Greco, Linda Hanson, Craig Schulz, Michael Schneider, John Connett, Francis Keefe, Ronald M Glick, Gert Bronfort
Author Information
Brent Leininger: Integrative Health and Wellbeing Research Program, Earl E. Bakken Center for Spirituality and Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, Minneapolis, MN, 55414, USA. lein0122@umn.edu.
Roni Evans: Integrative Health and Wellbeing Research Program, Earl E. Bakken Center for Spirituality and Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, Minneapolis, MN, 55414, USA.
Carol M Greco: School of Medicine, Department of Psychiatry, University of Pittsburgh, 580 S. Aiken Avenue, Suite 310, Pittsburgh, PA, 15232, USA.
Linda Hanson: Integrative Health and Wellbeing Research Program, Earl E. Bakken Center for Spirituality and Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, Minneapolis, MN, 55414, USA.
Craig Schulz: Integrative Health and Wellbeing Research Program, Earl E. Bakken Center for Spirituality and Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, Minneapolis, MN, 55414, USA.
Michael Schneider: Doctor of Chiropractic Program, School of Health and Rehabilitation Sciences, University of Pittsburgh, Bridgeside Point 1, 100 Technology Drive, Suite 500, Pittsburgh, PA, 15219, USA.
John Connett: School of Public Health, Division of Biostatistics, University of Minnesota, 717 Delaware Street SE, 2Nd Floor, Minneapolis, MN, 5455, USA.
Francis Keefe: Pain Prevention and Treatment Research Program, Department of Psychiatry and Behavioral Sciences, Duke Medical Center, Duke University School of Medicine, Box 3159, Durham, NC, 27705, USA.
Ronald M Glick: School of Medicine, Departments of Psychiatry and Physical Medicine and Rehabilitation, University of Pittsburgh, 580 S. Aiken Avenue, Suite 310, Pittsburgh, PA, 15232, USA.
Gert Bronfort: Integrative Health and Wellbeing Research Program, Earl E. Bakken Center for Spirituality and Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, Minneapolis, MN, 55414, USA.
BACKGROUND: There is limited high-quality research examining conservative treatments for back-related leg pain (BRLP). This feasibility study was done in preparation for a full-scale trial comparing a whole-person supported self-management intervention to medical care for chronic BRLP. METHODS: Participants were randomized to 12 weeks of individualized supported self-management delivered by physical therapists and chiropractors or medical care consisting of guideline-based pharmacologic care. Supported self-management was based on a behavioral model that used a whole person approach to enhance participants capabilities, opportunities, and motivations to engage in self-care. It combined BRLP education with psychosocial strategies (e.g., relaxed breathing, progressive muscle relaxation, guided imagery, communication skills) and physical modalities such as exercise and spinal manipulation therapy. Providers were trained to address participants' individualized needs and use behavior change and motivational communication techniques to develop a therapeutic alliance to facilitate self-management. Feasibility was assessed using pre-specified targets for recruitment and enrollment, intervention delivery, and data collection over the six-month study period. In addition, areas for potential refinement and optimization of processes and protocols for the full-scale trial were assessed. RESULTS: We met or exceeded nearly all feasibility targets. Forty-two participants were enrolled over a six-month period in 2022 and very few individuals declined participation due to preferences for one treatment. All but one participant received treatment and 95% of participants attended the minimum number of visits (self-management = 6, medical care = 2). At 12 weeks, 95% of participants in the self-management group reported engaging in self-management practices learned in the program and 77% of medical care participants reported taking medications as prescribed. Satisfaction with the self-management intervention was high with 85% of participants reporting satisfaction with the program overall. Self-management intervention providers delivered all required activities at 72% of visits. Providers also noted some challenges navigating the shared decision-making process and deciding what self-management tools to prioritize. Over the six-month study period, completion rates were 91% for monthly surveys and 86% for weekly surveys. CONCLUSION: We were able to demonstrate that a full-scale randomized trial comparing a whole-person supported self-management intervention to medical care for chronic BRLP is feasible and identified important areas for optimization.
