Geraghty Adam W A, Becque Taeko, Roberts Lisa C, Hill Jonathan, Foster Nadine E, Yardley Lucy, Stuart Beth, Turner David A, Griffiths Gareth, Webley Frances, Durcan Lorraine, Morgan Alannah, Hughes Stephanie, Bathers Sarah, Butler-Walley Stephanie, Wathall Simon, Mansell Gemma, White Malcolm, Davies Firoza, Little Paul
Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.
School of Health Sciences, University of Southampton, Southampton, UK and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Health Technol Assess. 2025 Apr;29(7):1-90. doi: 10.3310/GDPS2418.
Low back pain is highly prevalent and a leading cause of disability. Internet-delivered interventions may provide rapid and scalable support for behavioural self-management. There is a need to determine the effectiveness of highly accessible, internet-delivered support for self-management of low back pain.
To determine the clinical and cost-effectiveness of an accessible internet intervention, with and without physiotherapist telephone support, on low back pain-related disability.
A multicentre, pragmatic, three parallel-arm randomised controlled trial with parallel economic evaluation.
Participants were recruited from 179 United Kingdom primary care practices.
Participants had current low back pain without indicators of serious spinal pathology.
Participants were block randomised by a computer algorithm (stratified by severity and centre) to one of three trial arms: (1) usual care, (2) usual care + internet intervention and (3) usual care + internet intervention + telephone support. 'SupportBack' was an accessible internet intervention. A physiotherapist telephone support protocol was integrated with the internet programme, creating a combined intervention with three brief calls from a physiotherapist.
The primary outcome was low back pain-related disability over 12 months using the Roland-Morris Disability Questionnaire with measures at 6 weeks, 3, 6 and 12 months. Analyses used repeated measures over 12 months, were by intention to treat and used 97.5% confidence intervals. The economic evaluation estimated costs and effects from the National Health Service perspective. A cost-utility study was conducted using quality-adjusted life-years estimated from the EuroQol-5 Dimensions, five-level version. A cost-effectiveness study estimated cost per point improvement in the Roland-Morris Disability Questionnaire. Costs were estimated using data from general practice patient records. Researchers involved in data collection and statistical analysis were blind to group allocation.
Eight hundred and twenty-five participants were randomised (274 to usual primary care, 275 to usual care + internet intervention and 276 to the physiotherapist-supported arm). Follow-up rates were 83% at 6 weeks, 72% at 3 months, 70% at 6 months and 79% at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 internet intervention, 242 telephone support). There was a small reduction in the Roland-Morris Disability Questionnaire over 12 months compared to usual care following the internet intervention without physiotherapist support (adjusted mean difference of -0.5, 97.5% confidence interval -1.2 to 0.2; = 0.085) and the internet intervention with physiotherapist support (-0.6, 97.5% confidence interval -1.2 to 0.1; = 0.048). These differences were not statistically significant at the level of 0.025. There were no related serious adverse events. Base-case results indicated that both interventions could be considered cost-effective compared to usual care at a value of a quality-adjusted life-year of £20,000; however, the SupportBack group dominated usual care, being both more effective and less costly.
The internet intervention, with or without physiotherapist telephone support, did not significantly reduce low back pain-related disability across 12 months, compared to usual primary care. The interventions were safe and likely to be cost-effective. Balancing clinical effectiveness, cost-effectiveness, accessibility and safety findings will be necessary when considering the use of these interventions in practice.
This trial is registered as ISRCTN14736486.
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/111/78) and is published in full in ; Vol. 29, No. 7. See the NIHR Funding and Awards website for further award information.
腰痛极为普遍，是导致残疾的主要原因。通过互联网提供的干预措施可为行为自我管理提供快速且可扩展的支持。有必要确定高度易获取的、通过互联网提供的支持对腰痛自我管理的有效性。
确定一种易获取的互联网干预措施（有或没有物理治疗师电话支持）对腰痛相关残疾的临床效果和成本效益。
一项多中心、务实的三平行组随机对照试验，并进行平行经济评估。
参与者从英国179家初级医疗诊所招募。
参与者目前患有腰痛，但无严重脊柱病变指标。
参与者通过计算机算法进行整群随机分组（按严重程度和中心分层），分为三个试验组之一：（1）常规护理，（2）常规护理 + 互联网干预，（3）常规护理 + 互联网干预 + 电话支持。“SupportBack”是一种易获取的互联网干预措施。物理治疗师电话支持方案与互联网程序相结合，形成一种联合干预措施，物理治疗师进行三次简短通话。
主要结局是使用罗兰 - 莫里斯残疾问卷在12个月内的腰痛相关残疾情况，在6周、3个月、6个月和12个月时进行测量。分析采用12个月的重复测量，按意向性分析，使用97.5%置信区间。经济评估从英国国家医疗服务体系的角度估计成本和效果。使用从欧洲五维健康量表五级版本估计的质量调整生命年进行成本效用研究。成本效益研究估计罗兰 - 莫里斯残疾问卷每改善一分的成本。成本使用来自全科医疗患者记录的数据进行估计。参与数据收集和统计分析的研究人员对分组分配情况不知情。
825名参与者被随机分组（274名接受常规初级护理，275名接受常规护理 + 互联网干预，276名接受物理治疗师支持组）。6周时随访率为83%，3个月时为72%，6个月时为70%，12个月时为79%。对于主要分析，736名参与者进行了分析（249名接受常规护理，245名接受互联网干预，242名接受电话支持）。与没有物理治疗师支持的互联网干预后的常规护理相比，12个月内罗兰 - 莫里斯残疾问卷有小幅降低（调整后平均差异为 -0.5，97.5%置信区间 -1.2至0.2；P = 0.085），以及与有物理治疗师支持的互联网干预相比（-0.6，97.5%置信区间 -1.2至0.1；P = 0.048）。这些差异在0.025水平上无统计学意义。没有相关严重不良事件。基础病例结果表明，与常规护理相比，在质量调整生命年价值为20,000英镑时，两种干预措施都可被认为具有成本效益；然而，SupportBack组优于常规护理，既更有效又成本更低。
与常规初级护理相比，有或没有物理治疗师电话支持的互联网干预在12个月内并未显著降低腰痛相关残疾。这些干预措施是安全的，且可能具有成本效益。在实际应用中考虑使用这些干预措施时，有必要权衡临床效果（有效性）、成本效益、可及性和安全性等方面的结果。
本试验注册为ISRCTN14736486。
本奖项由英国国家卫生与保健研究机构（NIHR）卫生技术评估项目资助（NIHR奖项编号：16/111/78），并全文发表于；第29卷，第7期。有关更多奖项信息，请参阅NIHR资助与奖项网站。
