Department of Physical and Occupational Therapy, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark
Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark.
Br J Sports Med. 2023 Oct;57(20):1287-1294. doi: 10.1136/bjsports-2022-106197. Epub 2023 May 3.
To assess effectiveness equivalence between two commonly prescribed 12-week exercise programmes targeting either the quadriceps or the hip muscles in patients with patellofemoral pain (PFP).
This randomised controlled equivalence trial included patients with a clinical diagnosis of PFP. Participants were randomly assigned to either a 12-week quadriceps-focused exercise (QE) or a hip-focused exercise (HE) programme. The primary outcome was the change in Anterior Knee Pain Scale (AKPS) (0-100) from baseline to 12-week follow-up. Prespecified equivalence margins of ±8 points on the AKPS were chosen to demonstrate comparable effectiveness. Key secondary outcomes were the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire pain, physical function and knee-related quality of life subscales.
200 participants underwent randomisation; 100 assigned to QE and 100 to HE (mean age 27.2 years (SD 6.4); 69% women). The least squares mean changes in AKPS (primary outcome) were 7.6 for QE and 7.0 for HE (difference 0.6 points, 95% CI -2.0 to 3.2; test for equivalence p<0.0001), although neither programme surpassed the minimal clinically important change threshold. None of the group differences in key secondary outcomes exceeded predefined equivalence margins.
The 12-week QE and HE protocols provided equivalent improvements in symptoms and function for patients with PFP.
NCT03069547.
评估针对髌股疼痛(PFP)患者的股四头肌或髋关节肌肉的两种常用 12 周运动方案的有效性等效性。
本随机对照等效性试验纳入了临床诊断为 PFP 的患者。参与者被随机分配到 12 周的股四头肌聚焦运动(QE)或髋关节聚焦运动(HE)方案。主要结局是从基线到 12 周随访时的前膝痛量表(AKPS)(0-100)变化。选择 AKPS 上 ±8 点的预设等效边界来证明等效的有效性。主要次要结局是膝关节损伤和骨关节炎结果评分(KOOS)问卷疼痛、身体功能和膝关节相关生活质量子量表。
200 名参与者接受了随机分组;100 名分配到 QE,100 名分配到 HE(平均年龄 27.2 岁(SD 6.4);69%为女性)。QE 的 AKPS(主要结局)最小平方均值变化为 7.6,HE 为 7.0(差异 0.6 点,95%CI-2.0 至 3.2;等效性检验 p<0.0001),尽管两种方案均未超过最小临床重要变化阈值。主要次要结局的组间差异均未超过预设的等效性边界。
12 周的 QE 和 HE 方案为 PFP 患者提供了等效的症状和功能改善。
NCT03069547。