Effects of an online program including mindfulness, exercise therapy and patient education compared to online exercise therapy and patient education for people with Patellofemoral Pain: protocol for a randomized clinical trial.

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR-4yhbqwk, registered in April 6, 2021.

Patellofemoral pain over time: Protocol for a prospective, longitudinal study investigating physical and non-physical features.

Background: This is a protocol for a prospective longitudinal study that aims to investigate: (1) group-by-time changes over a minimum of 15 months follow-up in patellofemoral pain (PFP) symptoms, biomechanical, muscle function, pain processing, and psychological features; (2) the extent to which changes in biomechanical, muscle function, pain processing, and psychological features are associated with changes in self-reported pain, physical performance measures, self-reported function, health-related quality of life (HRQOL), and physical activity level. Methods: Individuals with PFP (n = 144) and control individuals (n = 85) without PFP were assessed at baseline. Outcomes assessed included: 3D kinematics and kinetics during single leg squat, step-down and single leg hop; maximal torque and rate of torque development of hip abductors and knee extensors/flexors; force steadiness of hip abductors and knee extensors; anterior and lateral trunk endurance; pressure pain thresholds at the center of patella and contralateral shoulder; kinesiophobia (Tampa Scale for Kinesiophobia); pain catastrophizing (Pain Catastrophizing Scale); worst self-reported pain (Visual Analogue Scale); physical performance measures (Single Leg Hop Test and Forward Step-Down Test); self-reported function (Anterior Knee Pain Scale); HRQOL (Medical Outcome Short-Form 36), and physical activity level (Baecke's Questionnaire). Follow-up assessments will be identical to the baseline and will be performed after a minimum of 15 months. Generalized linear mixed model (GLMM) will be used to investigate group-by-time differences. Linear regression models will be used to determine the extent to which changes in biomechanical, muscle function, pain processing, and psychological features are associated with changes in self-reported pain, physical performance measures, self-reported function, HRQOL, and physical activity level. Discussion: Physical and non-physical features have been previously associated with PFP. However, the present study will be the first to investigate their integrated evolution as part of the natural history of PFP and its progression. In doing so, we will be able to determine their behavior in the long-term, as well as how they prospectively associate with each other and with clinical outcomes. Ultimately, this will provide a greater understanding of predictors of long-term outcome and possible targets for interventions.