个性化运动和足部矫形器治疗足跟足底疼痛的临床疗效及成本效益：TREADON随机多组多阶段适应性试验方案
Clinical and cost-effectiveness of individualised exercises and foot orthoses in the treatment of plantar heel pain: protocol for the TREADON randomised multi-arm multi-stage adaptive trial.
作者信息
Thomas Martin J, Hughes Gemma, Cooke Kendra, Butler-Walley Stephanie, Marshall Emma, Bowyer Laura, Wathall Simon, Smith Jo, Lawton Sarah A, Brammar June, Burnett Thomas, Drake Chris, Foster Nadine E, Hendry Gordon J, Holden Melaine A, Jaki Thomas, Joseph Royes, Keenan Anne-Maree, Kigozi Jesse, Lewis Martyn, Mallen Christian D, Menz Hylton B, Mozgunov Pavel, Roddy Edward
机构信息
Centre for Musculoskeletal Health Research, School of Medicine, Keele University, Keele, Staffordshire, UK.
Midlands Partnership University NHS Foundation Trust, Haywood Hospital, Haywood Academic Rheumatology Centre, Burslem, Staffordshire, UK.
出版信息
NIHR Open Res. 2025 May 6;5:42. doi: 10.3310/nihropenres.13930.1. eCollection 2025.
BACKGROUND
Plantar heel pain (PHP) is the most common soft tissue foot condition and impairs mobility, physical function, ability to work, and quality of life. Systematic reviews highlight a need for high-quality randomised controlled trials (RCTs) of exercises and orthoses for PHP.
OBJECTIVES
To determine the clinical and cost-effectiveness of individualised exercises and/or prefabricated foot orthoses plus self-management advice (SMA) compared to SMA alone in adults with PHP.
METHODS
A multi-centre four-arm two-stage adaptive parallel-group RCT with internal pilot. Up to 696 participants aged ≥18 years with PHP will be identified from general practice, physiotherapy/podiatry referrals and self-referral, and randomised 1:1:1:1 to: (1) SMA (control), (2) SMA plus individualised exercises, (3) SMA plus prefabricated foot orthoses, or (4) SMA plus individualised exercises and prefabricated foot orthoses. Outcomes will be collected by SMS text-message (weekly during weeks 1-12, monthly during months 4-12) and questionnaires at 12 weeks and 6 and 12 months. The primary outcome is change in PHP intensity (0-10 numeric rating scale) between baseline and the average over 6-12 weeks. Interim analysis when 348 participants have completed the primary outcome assessment will inform adaptation, where interventions may be dropped or the trial stopped early (for efficacy or futility). The main between-group comparison for the primary outcome will be undertaken using linear mixed modelling. Secondary outcomes will examine i) short-term pain trajectories over weeks 1-12, ii) pain at 6 and 12 months, and monthly from 3-12 months, iii) first step pain, physical function, global rating of change, pain self-efficacy, illness perceptions, ability to work, and treatment satisfaction at 12 weeks, 6 and 12 months, iv) cost-effectiveness. Patient and public partner involvement is embedded throughout.
DISCUSSION
The TREADON multi-arm multi-stage RCT will provide new evidence on the clinical and cost-effectiveness of individualised exercises and prefabricated foot orthoses for people with PHP.
TRIAL REGISTRATION
- Registration date 06 December 2022 https://doi.org/10.1186/ISRCTN12418153.
背景
足跟足底疼痛（PHP）是最常见的足部软组织疾病，会损害行动能力、身体功能、工作能力和生活质量。系统评价强调需要针对PHP的运动和矫形器进行高质量的随机对照试验（RCT）。
目的
确定与单纯自我管理建议（SMA）相比，个体化运动和/或预制足矫形器加SMA对成年PHP患者的临床效果和成本效益。
方法
一项多中心四臂两阶段适应性平行组RCT，设有内部预试验。将从全科医疗、物理治疗/足病转诊和自我转诊中识别出多达696名年龄≥18岁的PHP患者，并按1:1:1:1随机分为：（1）SMA（对照组），（2）SMA加个体化运动，（3）SMA加预制足矫形器，或（4）SMA加个体化运动和预制足矫形器。结果将通过短信（第1 - 12周每周一次，第4 - 12个月每月一次）以及在12周、6个月和12个月时通过问卷收集。主要结局是基线至6 - 12周平均水平之间PHP强度的变化（0 - 10数字评分量表）。当348名参与者完成主要结局评估时进行中期分析，以指导调整，在此过程中可能会放弃某些干预措施或提前终止试验（出于疗效或无效性考虑）。主要结局的组间主要比较将采用线性混合模型进行。次要结局将检查：i）第1 - 12周的短期疼痛轨迹，ii）6个月和12个月时的疼痛，以及第3 - 12个月每月的疼痛，iii）第12周、6个月和12个月时的第一步疼痛、身体功能、总体变化评分、疼痛自我效能、疾病认知、工作能力和治疗满意度，iv）成本效益。患者和公众合作伙伴参与贯穿始终。
讨论
TREADON多臂多阶段RCT将为个体化运动和预制足矫形器对PHP患者的临床效果和成本效益提供新的证据。
试验注册
12418153。注册日期2022年12月6日https://doi.org/10.1186/ISRCTN12418153。
Zotero 插件