Pain Research Group, Pain Center, Odense University Hospital, Odense, Denmark.
Department of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.
Phys Ther. 2021 Sep 1;101(9). doi: 10.1093/ptj/pzab132.
Chronic low back pain (cLBP) is the leading cause of disability. Interdisciplinary pain management is recommended for patients with severe/high-impact cLBP. Such programs are expensive, not easily accessible, and have limited effect; therefore, new cost-effective strategies are warranted. Cognitive functional therapy (CFT) has shown promising results but has not been compared with an interdisciplinary pain management approach. The primary aim of this randomized controlled trial is to investigate if a pathway starting with CFT including psychologist support (CFT+) with the option of additional usual care (if needed) is superior in improving disability and more cost-effective at 12 months compared with an interdisciplinary pain management pathway (usual care).
This pragmatic, 2-arm, parallel-group randomized controlled trial will randomly allocate patients (n = 176) aged 18 to 75 years referred to an interdisciplinary pain center due to severe cLBP to 1 of 2 groups (1:1 ratio). Participants randomized to CFT+ will participate in a 3-month functional rehabilitation pathway with the option of additional usual care (if needed), and participants randomized to the interdisciplinary pain management pathway will participate in an individualized program of longer duration designed to best suit the individual's situation, needs, and resources. The primary outcome is the proportion of participants with an 8-point improvement in the Oswestry Disability Index score at 12 months. Exploratory outcomes are change in Oswestry Disability Index scores over time and an economic analysis of quality-adjusted life years using the 3-level version of the EuroQol EQ-5D.
The study evaluates the cost-effectiveness of CFT+ with the option of additional usual care (if needed) for individuals with severe cLBP. Findings can potentially improve future care pathways and reduce cost for the health care system.
慢性下腰痛（cLBP）是导致残疾的主要原因。对于严重/高影响的 cLBP 患者，建议采用跨学科疼痛管理。此类方案费用高昂、难以获得，且效果有限；因此，需要新的具有成本效益的策略。认知功能疗法（CFT）已显示出良好的效果，但尚未与跨学科疼痛管理方法进行比较。本随机对照试验的主要目的是研究从包括心理学家支持的 CFT 开始的途径（如果需要，可加上额外的常规护理）是否优于跨学科疼痛管理途径（常规护理），以改善残疾状况，并在 12 个月时更具成本效益。
这是一项实用的、2 臂、平行组随机对照试验，将 18 至 75 岁因严重 cLBP 被转诊到跨学科疼痛中心的患者（n = 176）随机分为 2 组（1:1 比例）。随机分配到 CFT+的参与者将参加为期 3 个月的功能康复途径，如果需要，可加上额外的常规护理；随机分配到跨学科疼痛管理途径的参与者将参加个体化的、时间更长的方案，旨在最好地满足个人的情况、需求和资源。主要结局是在 12 个月时 Oswestry 残疾指数评分提高 8 分的参与者比例。探索性结局是 Oswestry 残疾指数评分随时间的变化，以及使用 3 级欧洲五维健康量表（EQ-5D）进行质量调整生命年的经济分析。
该研究评估了 CFT+加上额外的常规护理（如果需要）对严重 cLBP 患者的成本效益。研究结果可能会改善未来的护理途径，并降低医疗保健系统的成本。
