Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.
Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.
Lancet Rheumatol. 2024 Jul;6(7):e424-e437. doi: 10.1016/S2665-9913(24)00086-9. Epub 2024 May 30.
Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack).
Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486.
Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference -0·5 [97·5% CI -1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (-0·6 [-1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care.
The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice.
National Institute for Health and Care Research Health Technology Assessment (16/111/78).
腰痛普遍存在，是导致残疾的主要原因。我们旨在确定一种易于获取且可扩展的互联网干预措施在支持行为自我管理方面的临床和成本效益，该措施被称为 SupportBack。
英国初级保健机构中患有腰痛但无严重脊柱病理的患者，按照残疾程度和电话支持中心分层，采用计算机算法，以 1:1:1 的比例随机分配至常规护理、常规护理加 SupportBack 或常规护理加 SupportBack 加物理治疗师电话支持（三次简短电话）。主要结局指标为 6 周、3 个月、6 个月和 12 个月时的腰痛相关残疾（Roland Morris 残疾问卷 [RMDQ] 评分），使用重复测量模型进行分析，采用 97.5%CI 进行意向治疗分析。采用健康服务视角的平行经济评估来估计成本效益。从试验开始，有腰痛实际经验的人参与了这项试验。这项完成的试验在 ISRCTN 和 ISRCTN14736486 上进行了注册。
在 2018 年 11 月 29 日至 2021 年 1 月 12 日期间，825 名参与者被随机分配（274 名接受常规护理，275 名接受仅 SupportBack，276 名接受 SupportBack 加电话支持）。参与者的平均年龄为 54（SD 15）岁，821 名参与者中有 479（58%）名女性和 342（42%）名男性，641 名参与者中有 591（92%）名是白人。随访率在 6 周时为 687（83%），3 个月时为 598（73%），6 个月时为 589（72%），12 个月时为 652（79%）。对于主要分析，有 736 名参与者被分析（249 名接受常规护理，245 名接受 SupportBack，242 名接受 SupportBack 加电话支持）。在显著性水平为 0.025 时，SupportBack 与常规护理相比（调整后的平均差异 -0.5[97.5%CI-1.2 至 0.2]；p=0.085）或 SupportBack 加电话支持与常规护理相比（-0.6[-1.2 至 0.1]；p=0.048），RMDQ 在 12 个月时没有差异。没有与治疗相关的严重不良事件。经济评估表明，SupportBack 组优于常规护理，不仅更有效，而且成本更低。与常规护理相比，在 20000 英镑/QALY 的阈值下，这两种干预措施都很可能具有成本效益。
与常规护理相比，SupportBack 互联网干预措施在 12 个月内并未显著降低腰痛相关残疾。它们可能具有成本效益和安全性。在确定是否将这些干预措施应用于临床实践时，应综合考虑临床效果、成本效益和安全性。
英国国家卫生与保健优化研究所卫生技术评估（16/111/78）。
