Rehabilitation Sciences and Physiotherapy, University of Antwerp Faculty of Medicine and Health Sciences, Wilrijk, Belgium
Institute for Therapy and Rehabilitation, Kantonsspital Winterthur, Winterthur, Zurich, Switzerland.
BMJ Open. 2022 Aug 4;12(8):e058803. doi: 10.1136/bmjopen-2021-058803.
Prognosis following surgical rotator cuff repair (RCR) is often established through the assessment of non-modifiable biomedical factors such as tear size. This understates the complex nature of recovery following RCR. There is a need to identify modifiable psychosocial and sleep-related variables, and to find out whether changes in central pain processing influence prognosis after RCR. This will improve our knowledge on how to optimise recovery, using a holistic rehabilitation approach.
This longitudinal study will analyse 141 participants undergoing usual care for first time RCR. Data will be collected 1-21 days preoperatively (T1), then 11-14 weeks (T2) and 12-14 months (T3) postoperatively. We will use mixed-effects linear regression to assess relationships between potential prognostic factors and our primary and secondary outcome measures-the Western Ontario Rotator Cuff Index; the Constant-Murley Score; the Subjective Shoulder Value; Maximal Pain (Numeric Rating Scale); and Quality of Life (European Quality of Life, 5 dimensions, 5 levels). Potential prognostic factors include: four psychosocial variables; pain catastrophising, perceived stress, injury perceptions and patients' expectations for RCR; sleep; and four factors related to central pain processing (central sensitisation inventory, temporal summation, cold hyperalgesia and pressure pain threshold). Intercorrelations will be assessed to determine the strength of relationships between all potential prognostic indicators.Our aim is to explore whether modifiable psychosocial factors, sleep-related variables and altered central pain processing are associated with outcomes pre-RCR and post-RCR and to identify them as potential prognostic factors.
The results of the study will be disseminated at conferences such as the European Pain Congress. One or more manuscripts will be published in a peer-reviewed SCI-ranked journal. Findings will be reported in accordance with the STROBE statement and PROGRESS framework. Ethical approval is granted by the Ethical commission of Canton of Zurich, Switzerland, No: ID_2018-02089 TRIAL REGISTRATION NUMBER: NCT04946149.
通过评估不可改变的生物医学因素，如撕裂大小，通常可以确定肩部手术修复（RCR）后的预后。但这低估了 RCR 后恢复的复杂性。有必要确定可改变的心理社会和睡眠相关变量，并确定中枢疼痛处理的变化是否会影响 RCR 后的预后。这将通过采用整体康复方法，提高我们关于如何优化康复的知识。
这项纵向研究将分析 141 名首次接受 RCR 常规治疗的参与者。数据将在术前 1-21 天（T1）、术后 11-14 周（T2）和 12-14 个月（T3）收集。我们将使用混合效应线性回归来评估潜在预后因素与我们的主要和次要结果指标（Western Ontario Rotator Cuff Index；Constant-Murley Score；Subjective Shoulder Value；最大疼痛（数字评分量表）和生活质量（欧洲生活质量，5 维度，5 级）之间的关系。潜在的预后因素包括：四个心理社会变量；疼痛灾难化、感知压力、损伤认知和患者对 RCR 的期望；睡眠；以及与中枢疼痛处理相关的四个因素（中枢敏感化量表、时间总和、冷痛觉过敏和压痛阈值）。将评估相关性以确定所有潜在预后指标之间关系的强度。我们的目的是探讨可改变的心理社会因素、睡眠相关变量和改变的中枢疼痛处理是否与 RCR 前和 RCR 后结果相关，并将其确定为潜在的预后因素。
该研究的结果将在欧洲疼痛大会等会议上公布。一篇或多篇论文将发表在同行评议的 SCI 排名期刊上。研究结果将按照 STROBE 声明和 PROGRESS 框架进行报告。瑞士苏黎世州伦理委员会已批准该研究，注册号为 ID_2018-02089。
NCT04946149。
