Department of Physiotherapy, School of Science and Technology, Sao Paulo State University (UNESP), 305 Roberto Simonsen St, Presidente Prudente, SP, 19060-900, Brazil.
Brazilian Center for Mindfulness and Health Promotion - Mente Aberta, Federal University of Sao Paulo (Unifesp), Sao Paulo, Brazil.
BMC Musculoskelet Disord. 2023 May 11;24(1):372. doi: 10.1186/s12891-023-06491-x.
Patellofemoral pain (PFP) is a common knee disorder that causes persistent pain, lower self-reported function and quality of life. People with PFP also present with altered psychological factors, which are associated with higher levels of pain and dysfunction. Mindfulness-based interventions (MBI) generally consist of meditative practices developed to provide a holistic approach to chronic conditions. However, the effects of MBI on clinical and psychological outcomes for people with PFP remains understudied.
This assessor-blinded, parallel, two-arm randomized clinical trial aims to investigate the effects of adding an 8-week online MBI program to exercise therapy and patient education on clinical and psychological factors for people with PFP. We also aim to investigate whether psychological factors mediate changes in pain and function. Sixty-two participants with PFP will be recruited and randomized into one of two treatment groups (Mindfulness or Control group). Both groups will receive an 8-week intervention involving exercise therapy and education delivered through an online platform. The Mindfulness group will additionally receive a MBI component including formal and informal practices. Outcomes will be assessed online at baseline, intervention endpoint (follow-up 1) and 12 months after intervention completion (follow-up 2). Comparisons between groups will be performed at all time points with linear mixed models. A mediation analysis will be performed using a 3-variable framework.
Exercise therapy and patient education are considered the "best management" options for PFP. However, unsatisfactory long-term prognosis remains an issue. It is known that people with PFP present with altered psychological factors, which should be considered during the evaluation and treatment of people with PFP. Adding a MBI to the current best treatment for PFP may improve short and long-term effects by addressing the underlying psychological factors.
Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR-4yhbqwk, registered in April 6, 2021.
髌股疼痛（PFP）是一种常见的膝关节疾病，会导致持续疼痛、自我报告功能下降和生活质量降低。患有 PFP 的人还表现出改变的心理因素，这些因素与更高水平的疼痛和功能障碍相关。基于正念的干预（MBI）通常包括冥想练习，旨在为慢性疾病提供整体方法。然而，MBI 对 PFP 患者的临床和心理结果的影响仍有待研究。
这是一项评估者盲法、平行、双臂随机临床试验，旨在研究在运动疗法和患者教育的基础上增加 8 周在线 MBI 方案对 PFP 患者的临床和心理因素的影响。我们还旨在研究心理因素是否调节疼痛和功能的变化。将招募 62 名 PFP 患者并将其随机分为两组（正念组或对照组）。两组都将接受 8 周的干预，包括通过在线平台提供的运动疗法和教育。正念组还将接受 MBI 部分，包括正式和非正式练习。将在基线、干预终点（随访 1）和干预完成后 12 个月（随访 2）在网上评估结果。将使用线性混合模型在所有时间点比较组间差异。将使用 3 变量框架进行中介分析。
运动疗法和患者教育被认为是 PFP 的“最佳管理”选择。然而，不满意的长期预后仍然是一个问题。已知 PFP 患者表现出改变的心理因素，在评估和治疗 PFP 患者时应考虑这些因素。将 MBI 加入到 PFP 的当前最佳治疗方法中，通过解决潜在的心理因素，可能会改善短期和长期效果。
巴西临床试验注册中心（ReBEC）RBR-4yhbqwk，于 2021 年 4 月 6 日注册。
