Faculty of Health, Social Care & Medicine, Edge Hill University, St Helen's Road, Ormskirk, Lancashire, L39 4QP, UK.
Faculty of Health, Social Care & Medicine, Edge Hill University, St Helen's Road, Ormskirk, Lancashire, L39 4QP, UK.
Musculoskelet Sci Pract. 2023 Nov;68:102874. doi: 10.1016/j.msksp.2023.102874. Epub 2023 Oct 30.
Once a decision to undergo rotator cuff repair surgery is made, patients are placed on the waiting list. It can take weeks or months to receive surgery. There has been a call to move from waiting lists to 'preparation' lists to better prepare patients for surgery and to ensure it remains an appropriate treatment option for them.
To evaluate the feasibility, as measured by recruitment rates, treatment fidelity and follow-up rates, of a future multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of undertaking a physiotherapist-led exercise programme while waiting for surgery versus usual care (waiting-list control).
Two-arm, multi-centre pilot randomised controlled trial with feasibility objectives in six NHS hospitals in England.
Adults (n = 76) awaiting rotator cuff repair surgery were recruited and randomly allocated to a programme of physiotherapist-led exercise (n = 38) or usual care control (n = 38).
Of 302 eligible patients, 76 (25%) were randomised. Of 38 participants randomised to physiotherapist-led exercise, 28 (74%) received the exercise programme as intended. 51/76 (67%) Shoulder Pain and Disability Index questionnaires were returned at 6-months. Of 76 participants, 32 had not received surgery after 6-months (42%). Of those 32, 20 were allocated to physiotherapist-led exercise; 12 to usual care control.
A future multi-centre randomised controlled trial is feasible but would require planning for variable recruitment rates between sites, measures to improve treatment fidelity and opportunity for surgical exit, and optimisation of follow-up. A fully powered, randomised controlled trial is now needed to robustly inform clinical decision-making.
一旦决定进行肩袖修复手术，患者就会被列入等候名单。他们可能需要数周或数月的时间才能接受手术。有人呼吁将等候名单改为“准备”名单，以更好地为患者准备手术，并确保手术仍然是他们的合适治疗选择。
评估一项未来多中心随机对照试验的可行性，该试验将比较在等待手术期间进行物理治疗师主导的运动计划与常规护理（等候名单对照）的临床和成本效益，以招募率、治疗保真度和随访率为衡量标准。
在英格兰的 6 家 NHS 医院进行的两臂、多中心试点随机对照试验，具有可行性目标。
招募等待肩袖修复手术的成年人（n=76），并将其随机分配到物理治疗师主导的运动计划（n=38）或常规护理对照组（n=38）。
在 302 名符合条件的患者中，有 76 名（25%）被随机分配。在随机分配到物理治疗师主导的运动计划的 38 名参与者中，28 名（74%）按照预期接受了运动计划。在 6 个月时，有 51/76（67%）的肩痛和残疾指数问卷得到了回复。在 76 名参与者中，有 32 名在 6 个月后仍未接受手术（42%）。在这 32 名患者中，20 名被分配到物理治疗师主导的运动组；12 名被分配到常规护理对照组。
未来的多中心随机对照试验是可行的，但需要计划在不同地点之间的可变招募率、提高治疗保真度的措施和手术出口的机会，并优化随访。现在需要进行一项充分的、随机对照试验，以稳健地为临床决策提供信息。
