Inserção de consumidores no desenvolvimento de um ensaio clínico: co-design com pacientes e fisioterapeutas na criação de um estudo em dor patelofemoral

Abstract

Patellofemoral pain (PFP) is characterized by insidious-onset pain in the retropatellar and/or peripatellar region, typically worsened by activities such as running, squatting, jumping, kneeling, or prolonged sitting. With a high prevalence in the general population (22.7%) and more commonly affecting women PFP is a challenging condition to manage due to its complex and multifactorial etiology. Strengthening the quadriceps muscle is widely recommended by clinical practice guidelines for treating PFP. However, exercises targeting this muscle group place significant stress on the patellofemoral joint and are often poorly tolerated by patients. A common conservative strategy in clinical practice is to restrict the range of motion during knee extension exercises, limiting open kinetic chain movements to a protective range between 90° and 45° of knee flexion, and closed kinetic chain exercises between 0° and 45°. Although these restrictions help minimize joint stress, they may lead to suboptimal outcomes in patients who tolerate higher loads and may inadvertently reinforce maladaptive beliefs regarding joint fragility. This study comprised two scientific outputs. The first involved a co-design approach with end-users (physical therapists and patients) to develop a randomized controlled trial (RCT) protocol for PFP. was divided into four stages. Stage 1: Two clinical researchers developed a preliminary research question, intervention protocol, outcome assessments, and discussion prompts for the meetings. Stage 2: Focus groups were conducted with patients and physiotherapists to gather input from stakeholders. Stage 3: Organize and summarize the information obtained after each session. Stage 4: The research team reviewed and adapted the suggestions provided by the stakeholder. Active involvement of these stakeholders was critical to identify research gaps, promote a patient- centered approach, and enhance the clinical relevance of the protocol. A total of ten physical therapists and eleven patients were recruited, contributing thirteen and seven suggestions, respectively. Key modifications included adding quadriceps muscle strength as a secondary outcome and replacing the primary outcome of self-reported function with kinesiophobia. The second output provided a detailed description of the RCT intervention protocol, comparing two strategies: quadriceps strengthening within a protective range versus strengthening with patient-guided range of motion, targeting individuals with PFP. This study offers valuable insights for designing more effective rehabilitation programs.