Physiotherapy Department, Blacktown Mt Druitt Hospital, Western Sydney Local Health District, Blacktown, New South Wales, Australia
Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
BMJ Open. 2020 Jun 3;10(6):e032675. doi: 10.1136/bmjopen-2019-032675.
Incidence of total knee arthroplasty (TKA) is projected to rise 276% in 2030, and psychological distress affects up to 42% of people with knee osteoarthritis undergoing TKA, with demonstrated detrimental effects on postoperative outcomes. Few studies have assessed psychological treatment in people awaiting TKA, and these have been psychologist-delivered treatments. No evidence exists regarding psychologically-informed interventions delivered by health professionals currently embedded in TKA clinical pathways. The primary aim of this pilot study is to explore the safety, acceptability and feasibility of the nee steoarthritis anagement with hysiotherapy informed by cceptance and ommitment herapy (KOMPACT) approach in people awaiting TKA.
51 community-dwelling adults scheduled for a primary TKA at two hospitals will be recruited to this pilot, mixed-methods, prospective randomised controlled trial with assessor blinding. Participants will be randomised in a 1:2 ratio to either usual care (education class) or usual care plus KOMPACT (2 hours 20 min of preoperative physiotherapy informed by Acceptance and Commitment Therapy). Our primary outcome measures are safety (length of stay, complications and psychological health after KOMPACT), acceptability (treatment credibility and qualitative data) and feasibility (recruitment, retention and intervention fidelity) of the KOMPACT approach. Secondary outcomes include health service outcomes, patient-reported physical and psychological outcomes, and physical performance measures. Quantitative data collection was conducted at baseline, 1-2 weeks before TKA, 6 weeks after TKA and 6 months after TKA. Qualitative data collection is 1-2 weeks before TKA. Data analysis will take a quantitative-led approach with triangulation after thematic analysis of the qualitative data.
This study has full ethics approval (HREC/18/WMEAD/440). Results from this study will be published in peer-reviewed journals and presented at local and international conferences.
Australia New Zealand Clinical Trials Registry (ACTRN12618001867280p).
预计到 2030 年，全膝关节置换术（TKA）的发病率将上升 276%，接受 TKA 的膝骨关节炎患者中高达 42%的人存在心理困扰，这对术后结果有不利影响。很少有研究评估 TKA 等待患者的心理治疗，且这些研究都是心理学家提供的治疗。目前，在 TKA 临床路径中嵌入的医疗保健专业人员提供的心理干预措施，尚无证据证明。本初步研究的主要目的是探讨接受 TKA 的人群中，基于接受与承诺疗法（KOMPACT）的新型关节炎管理与物理治疗（nee steoarthritis anagement with hysiotherapy informed by cceptance and ommitment herapy，KOMPACT）方法的安全性、可接受性和可行性。
本研究是一项试点、混合方法、前瞻性随机对照试验，采用盲法评估员，招募了 51 名在两家医院接受初次 TKA 的社区居住成年人。参与者将以 1:2 的比例随机分配到常规护理（教育课程）或常规护理加 KOMPACT（2 小时 20 分钟术前物理治疗，基于接受与承诺疗法）。我们的主要结局指标是 KOMPACT 方法的安全性（住院时间、并发症和 KOMPACT 后的心理健康）、可接受性（治疗可信度和定性数据）和可行性（招募、保留和干预一致性）。次要结局包括卫生服务结局、患者报告的身体和心理结局以及身体表现测量。定量数据收集在基线、TKA 前 1-2 周、TKA 后 6 周和 TKA 后 6 个月进行。定性数据收集在 TKA 前 1-2 周进行。数据分析将采用定量为主的方法，对定性数据进行主题分析后进行三角分析。
本研究已获得充分的伦理批准（HREC/18/WMEAD/440）。本研究的结果将发表在同行评议的期刊上，并在当地和国际会议上展示。
澳大利亚新西兰临床试验注册中心（ACTRN12618001867280p）。
