Supervised versus self-managed rehabilitation for patients with an acute first-time or recurrent patellar dislocation: the Physiotherapy Rehabilitation Post Patellar Dislocation (PRePPeD) external pilot randomized controlled trial and embedded qualitative study.
Colin P Forde, Elizabeth Tutton, Matthew L Costa, Jonathan A Cook, Marloes Franssen, Duncan Appelbe, Rupert Barker, David J Keene, Georgina Taylor, Mark Deakin, Aran Horrell, Crispin Mortimer, Joy Edwards, Teswaree Sewdin, Lisa Irving, Alexander Herring, Andrew Waton, Genevieve Simpson, Paul Minty, Niall Maher, Sanjeev Anand
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引用次数: 0
Abstract
Aims: The aim of this study was to determine the feasibility of a full-scale randomized controlled trial (RCT) comparing two exercise-based rehabilitation interventions for patients with an acute patellar dislocation.
Methods: A two-group external pilot RCT and embedded qualitative study was conducted in five English NHS hospitals. Patients were aged ≥ 14 years with an acute (recruited ≤ 21 days of injury) first-time or recurrent patellar dislocation. Randomization was 1:1 to supervised rehabilitation (between four and six physiotherapy sessions of tailored advice and prescribed home exercises) or self-managed rehabilitation (one physiotherapy session of advice, exercise instruction, and the provision of materials to guide self-management). Quantitative feasibility objectives were: patients' willingness to be randomized; patient recruitment; adherence to the intervention (overall proportion of supervised rehabilitation patients who attended at least four physiotherapy sessions and self-managed rehabilitation patients who attended at least one session); and retention. Follow-up was at three, six, and nine months after randomization. There was no blinding. Semistructured interviews aimed to understand patients' experience of recovery, and the acceptability to them of the interventions and the methods of follow-up.
Results: A total of 50 of 88 eligible patients (57% (95% CI 46 to 67)) were willing to be randomized. Sites recruited a mean of 1.4 patients per month (95% CI 0.6 to 1.8), the rate of adherence to the intervention was 72% (95% CI 58 to 83), and the rate of retention at nine months was 62% (95% CI 48 to 74). During follow-up, three patients redislocated the index patella and another underwent patellar stabilization surgery. Interviews with nine patients showed that the experience of recovery was conveyed through the themes 'coming to terms with the initial injury' and 'regaining my former self'. Interviews also indicated that the interventions and methods of follow-up were generally acceptable to patients.
Conclusion: A full-scale RCT comparing two exercise-based rehabilitation interventions for patients with an acute patellar dislocation is feasible with minor modifications. Modifications should prioritize improving retention and attendance at physiotherapy sessions.
目的：本研究的目的是确定一项全面随机对照试验（RCT）的可行性，比较两种基于运动的康复干预措施对急性髌骨脱位患者的影响。方法：在英国5家NHS医院进行两组外部先导随机对照试验和嵌入定性研究。患者年龄≥14岁，首次急性（受伤≤21天）或复发性髌骨脱位。随机分组为1:1：有监督的康复（4 - 6次物理治疗，提供量身定制的建议和规定的家庭运动）或自我管理的康复（1次物理治疗，提供建议、运动指导和指导自我管理的材料）。定量可行性目标为：患者随机化意愿；病人招募;干预依从性（至少参加四次物理治疗的受监督康复患者和至少参加一次物理治疗的自我管理康复患者的总比例）；和保留。随访时间分别为随机分组后3个月、6个月和9个月。没有致盲。半结构化访谈旨在了解患者的康复经历，以及他们对干预措施和随访方法的接受程度。结果：88例符合条件的患者中有50例（57% (95% CI 46 ~ 67)）愿意随机化。站点平均每月招募1.4名患者（95% CI 0.6至1.8），干预依从率为72% (95% CI 58至83)，9个月的保留率为62% （95% CI 48至74）。随访期间，3例患者髌骨再脱位，1例患者接受髌骨稳定手术。对9名患者的采访表明，康复的经历是通过“接受最初的伤害”和“恢复我以前的自己”这两个主题来传达的。访谈还表明，患者普遍接受干预措施和随访方法。结论：一项全面的随机对照试验比较了两种基于运动的康复干预措施对急性髌骨脱位患者的影响，只需稍加修改即可。修改应优先考虑提高物理治疗的保留率和出勤率。
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