Patellofemoral pain syndrome based on biomechanical monitoring and intervention: a single-center, prospective, interventional cohort study

Introduction Patellofemoral pain syndrome (PFPS) is a prevalent chronic knee disorder that poses significant clinical challenges due to its high incidence and suboptimal long-term outcomes. Current diagnostic approaches, primarily reliant on static imaging and subjective assessment, fail to capture the underlying dynamic biomechanical dysfunction. To address this gap, this study integrates dynamic radiography with three-dimensional gait analysis to construct a dynamic biomechanical model of the knee joint. We will quantify key parameters such as patellar tracking. The research is designed to achieve three core Objectives: firstly, to quantify dynamic biomechanical parameters in PFPS patients using dynamic DR and gait analysis; secondly, to compare the effects of biomechanically monitored targeted exercise combined with TCM vs. conventional exercise combined with TCM on pain and function; thirdly, to develop a biomechanics-guided clinical rehabilitation protocol for PFPS patients. Methods and analysis This single-centre, prospective, interventional cohort study will investigate the effectiveness of a biomechanically monitored targeted exercise protocol combined with Traditional Chinese Medicine (TCM) compared with conventional exercise combined with TCM in patients with patellofemoral pain syndrome (PFPS). We will consecutively recruit 96 eligible patients. Participants will be assigned to either an experimental group or a control group based on their preference after receiving standardized information. The experimental group will receive biomechanical monitoring, targeted exercise, and Traditional Chinese Medicine (TCM), whereas the control group will receive conventional exercise and the same TCM regimen. Outcomes will be assessed at baseline, 6 weeks, 6 months and 3 years post-intervention. The primary outcome measure will be pain intensity measured using the Visual Analog Scale (VAS). Secondary outcome measures will include: biomechanical parameters; pain (Knee Pain Scale); joint function (Lysholm Knee Scoring Scale); kinetic parameters (mean power and pulling acceleration during stair climbing using the IDEEA system); spatiotemporal gait parameters (walking speed, step frequency, double support time during stair climbing using IDEEA); and quality of life (36-Item Short Form Health Survey). For statistical analysis, independent samples t -tests will be used for between-group comparisons, and linear mixed-effects models will be applied for outcomes measured at multiple time points. To control for expectation bias, patients' treatment expectation scores will be recorded at baseline and adjusted as covariates if significant between-group differences exist. Baseline characteristics will be compared, and any imbalanced variables will be included as covariates in the primary analysis. A two-tailed P -value < 0.05 will be considered statistically significant.