Academic Rheumatology, University of Nottingham, Nottingham, UK.
NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, UK.
Rheumatology (Oxford). 2024 May 3;63(6):1582-1592. doi: 10.1093/rheumatology/kead432.
To evaluate the feasibility of conducting a cohort randomized controlled trial (RCT) of a nurse-led package of care for knee pain and determining a treatment sequence for use in a future trial.
This study was an open-label, three-arm, single-centre, mixed-methods, feasibility cohort RCT. Adults aged ≥40 years with moderate-to-severe knee pain for ≥3 months were eligible. Participants were randomized into group A (non-pharmacological treatment first), group B (pharmacological treatment first), or group C (usual care). The intervention was delivered over 26 weeks. Outcomes were dropout rate, recruitment rate, intervention fidelity, ability to collect outcome data, and treatment acceptability.
Seventeen participants were randomized and enrolled into each of groups A and B (5.2% recruitment rate), and 174 participants were randomized to group C. The participant characteristics at randomization were comparable across the three arms. Coronavirus disease (COVID-19) paused the study from March-November 2020. Participants enrolled in groups A and B before March 2020 were withdrawn at the restart. Of the 20 participants enrolled after the restart, 18 completed the study (10% dropout). The nurse reported delivering most aspects of the intervention with high fidelity. The participants viewed the package of care as structured, supportive and holistic, they learnt about self-managing knee pain, and they could engage with and follow the non-pharmacological treatment. Most found the non-pharmacological treatment more useful than the pharmacological treatment, preferring to receive it before or alongside analgesia. Many self-report questionnaires were not fully completed.
The nurse-led package of care for knee pain was acceptable, with low dropout, although the cohort RCT design may not be feasible for a definitive trial.
ClinicalTrials.gov, https://clinicaltrials.gov, NCT03670706.
评估由护士主导的膝关节疼痛护理套餐进行队列随机对照试验（RCT）的可行性，并确定未来试验中使用的治疗顺序。
这是一项开放标签、三臂、单中心、混合方法可行性队列 RCT 研究。年龄≥40 岁、膝关节疼痛≥3 个月且疼痛程度为中度至重度的成年人符合条件。参与者被随机分为 A 组（首先进行非药物治疗）、B 组（首先进行药物治疗）或 C 组（常规护理）。干预措施持续 26 周。主要结局为脱落率、招募率、干预一致性、获取结局数据的能力和治疗可接受性。
A 组和 B 组各有 17 名参与者随机分组并入组（招募率为 5.2%），C 组有 174 名参与者随机分组。三组参与者在随机分组时的特征相似。2020 年 3 月至 11 月，由于 COVID-19（冠状病毒病）暂停了研究。2020 年 3 月之前入组 A 组和 B 组的参与者在重启时退出研究。重启后入组的 20 名参与者中，18 名完成了研究（10%脱落）。护士报告说，该干预措施的大部分方面都得到了高度一致的实施。参与者认为该套餐式护理具有结构性、支持性和整体性，他们了解了膝关节疼痛的自我管理方法，并且能够接受和遵循非药物治疗。大多数人认为非药物治疗比药物治疗更有用，他们更愿意在接受镇痛药治疗之前或同时接受非药物治疗。许多自我报告问卷并未完全填写。
护士主导的膝关节疼痛护理套餐是可以接受的，脱落率较低，尽管队列 RCT 设计可能不适用于确定性试验。
ClinicalTrials.gov，https://clinicaltrials.gov，NCT03670706。
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