Development of a patient knowledge questionnaire for patellofemoral pain and a randomized clinical trial investigating education compared to placebo for individuals with patellofemoral pain

• Grant number: 23/15990-8
• Support Opportunities: Scholarships in Brazil - Doctorate
• Start date: March 01, 2024
• End date: May 07, 2027
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Fábio Mícolis de Azevedo
• Grantee: Ana Flavia Balotari Botta
• Host Institution: Faculdade de Ciências e Tecnologia (FCT). Universidade Estadual Paulista (UNESP). Campus de Presidente Prudente. Presidente Prudente , SP, Brazil

Abstract

Patellofemoral pain (PFP) is a chronic musculoskeletal condition with a multifactorial nature, involving biomechanical, psychological, and behavioral factors. The management of PFP is challenging, requiring multimodal and comprehensive interventions, such as patient education. Despite being suggested as an intervention with high potential in PFP management, patient education is under-investigated in the clinical trials. It is not clear whether the information delivered during education programs can indeed alter the level of knowledge about PFP and whether this is related to positive clinical effects. Additionally, there is no valid and standardized tool with which clinicians and researchers can measure the level of knowledge about PFP, which would assist them in directing educational interventions and enable the investigation of the relationship of this construct with important clinical outcomes. Therefore, the overall objectives of this project will be: (i) to develop a valid and reliable questionnaire to measure the level of knowledge about PFP; and (ii) to investigate the effect of a PFP education program compared to a placebo education program on pain, function, perceived improvement, knowledge about PFP, and secondary outcomes in individuals with PFP. To achieve these objectives, two studies will be conducted. In Study 1, a questionnaire for assessing knowledge about PFP will be constructed from items proposed by experts, clinicians, and individuals with PFP. The clinimetric properties (validity, reliability, and interpretability) of the questionnaire will be assessed according to the recommendations of the Consensus-based standards for the selection of health measurement instruments (COSMIN). In Study 2, a randomized clinical trial will be conducted. One hundred and twenty-two participants will be randomized to an education group that will receive online lectures on PFP or to a placebo education group that will receive lectures of the same format, application, and duration, but with topics on general health. Participants will be assessed for pain (Visual Analog Scale), function (Anterior Knee Pain Scale), perceived improvement (Global Rating of Change), knowledge about PFP, and secondary outcomes before and immediately after the intervention, and 6 and 12 months later.