A combined program of education plus exercise versus general advice for ankle osteoarthritis: A feasibility randomised controlled trial

IF 2.2 3区医学 Q1 REHABILITATION Musculoskeletal Science and Practice Pub Date : 2024-08-28 DOI:10.1016/j.msksp.2024.103169

Michelle D. Smith , Viana Vuvan , Natalie J. Collins , Melinda M. Franettovich Smith , Nathalia Costa , Zachary Southern , Tim Duffy , Alexander Downie , David J. Hunter , Bill Vicenzino

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Abstract

Background

Unlike hip and knee OA, there is little evidence to guide the management of ankle osteoarthritis (OA) and there are no clinical guidelines for ankle OA. Regardless of the body region, guidelines for treating OA typically include education, weight loss and exercise as the key components of management. Such an intervention has not been investigated in people with ankle OA.

Objectives

To determine the feasibility of conducting a randomised controlled trial (RCT) that compares physiotherapist-delivered education plus exercise to physiotherapist-delivered general advice for people with ankle OA. Secondarily, to inform planning for future RCTs.

Design

A randomised parallel-group feasibility trial.

Method

Study participants were recruited, assessed for eligibility, and randomised using 1:1 concealed allocation to receive either physiotherapist-delivered education plus exercise, or physiotherapist-delivered general advice. Primary feasibility outcomes were evaluated based on predetermined feasibility criteria. Secondary participant-reported and physical outcomes were collected to inform the design of future RCTs.

Results

Thirty participants (67% (n = 20) women, mean (standard deviation) age: 66.1 (11.5) years) were randomised. Data for key feasibility outcomes met a priori feasibility criteria: consent rate (97%), participant adherence with their allocated intervention arm (71%), fidelity of the intervention (94%) and rate of completion of outcome measures at 3 months (87%).

Conclusions

This study demonstrates that it is feasible to run an adequately powered RCT comparing physiotherapist-delivered education plus exercise versus physiotherapist-delivered general advice for people with ankle OA. Study data will inform the planning of a full-scale RCT.

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针对踝关节骨关节炎的教育加锻炼综合方案与一般建议：可行性随机对照试验

背景：与髋关节和膝关节 OA 不同，几乎没有证据可以指导踝关节骨关节炎（OA）的治疗，也没有针对踝关节 OA 的临床指南。无论身体处于哪个部位，治疗 OA 的指南通常都将教育、减肥和锻炼作为治疗的主要内容。目前尚未对踝关节 OA 患者进行过此类干预研究：目的：确定对踝关节OA患者进行随机对照试验（RCT）的可行性，将物理治疗师提供的教育加锻炼与物理治疗师提供的一般建议进行比较。其次，为未来的随机对照试验规划提供信息：随机平行组可行性试验：招募研究参与者，对其资格进行评估，并采用1:1随机分配法，将其随机分配为接受物理治疗师提供的教育加锻炼，或接受物理治疗师提供的一般建议。根据预先确定的可行性标准对主要可行性结果进行评估。此外，还收集了参与者报告的次要结果和身体结果，为今后的 RCT 设计提供参考：30名参与者（67%（n = 20）为女性，平均（标准差）年龄：66.1（11.5）岁）被随机分配。主要可行性结果的数据符合先验可行性标准：同意率（97%）、参与者对所分配干预措施的依从性（71%）、干预措施的忠实性（94%）和 3 个月结果测量的完成率（87%）：这项研究表明，对踝关节OA患者进行物理治疗师提供的教育加锻炼与物理治疗师提供的一般建议进行充分的RCT比较是可行的。研究数据将为规划全面的 RCT 提供依据。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Musculoskeletal Science and Practice Health Professions-Physical Therapy, Sports Therapy and Rehabilitation

CiteScore

4.10

自引率

8.70%

发文量

152

审稿时长

48 days

期刊介绍： Musculoskeletal Science & Practice, international journal of musculoskeletal physiotherapy, is a peer-reviewed international journal (previously Manual Therapy), publishing high quality original research, review and Masterclass articles that contribute to improving the clinical understanding of appropriate care processes for musculoskeletal disorders. The journal publishes articles that influence or add to the body of evidence on diagnostic and therapeutic processes, patient centered care, guidelines for musculoskeletal therapeutics and theoretical models that support developments in assessment, diagnosis, clinical reasoning and interventions.