Leininger Brent, Evans Roni, Greco Carol M, Hanson Linda, Schulz Craig, Schneider Michael, Connett John, Keefe Francis, Glick Ronald M, Bronfort Gert
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.
School of Medicine, Department of Psychiatry, University of Pittsburgh, 580 S. Aiken Avenue, Suite 310, Pittsburgh, PA, 15232, USA.
Chiropr Man Therap. 2025 Feb 5;33(1):6. doi: 10.1186/s12998-025-00570-7.
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.
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.
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.
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.
关于背部相关腿痛(BRLP)保守治疗的高质量研究有限。这项可行性研究是为一项全面试验做准备,该试验将比较针对慢性BRLP的全人支持自我管理干预与医疗护理。
参与者被随机分配接受由物理治疗师和脊椎按摩师提供的为期12周的个性化支持自我管理,或接受基于指南的药物护理的医疗护理。支持自我管理基于一种行为模型,该模型采用全人方法来增强参与者进行自我护理的能力、机会和动机。它将BRLP教育与心理社会策略(如放松呼吸、渐进性肌肉松弛、引导意象、沟通技巧)以及运动和脊椎推拿治疗等物理方式相结合。提供者接受培训以满足参与者的个性化需求,并使用行为改变和动机沟通技巧来建立治疗联盟以促进自我管理。在为期六个月的研究期间,使用预先设定的招募、入组、干预实施和数据收集目标来评估可行性。此外,还评估了全面试验中流程和方案的潜在改进和优化领域。
我们几乎达到或超过了所有可行性目标。2022年的六个月期间招募了42名参与者,很少有人因偏爱一种治疗而拒绝参与。除一名参与者外,所有参与者均接受了治疗,95%的参与者达到了最低就诊次数(自我管理组=6次,医疗护理组=2次)。在12周时,自我管理组95%的参与者报告在进行该项目中学到的自我管理实践,77%的医疗护理参与者报告按规定服药。对自我管理干预的满意度很高,85%的参与者报告对该项目总体满意。自我管理干预提供者在72%的就诊中提供了所有所需活动。提供者还指出在共同决策过程中以及决定优先使用哪些自我管理工具方面存在一些挑战。在为期六个月的研究期间,月度调查的完成率为每月91%,每周调查的完成率为86%。
我们能够证明,一项将针对慢性BRLP的全人支持自我管理干预与医疗护理进行比较的全面随机试验是可行的,并确定了重要的优化领域。