Effects of cognitive functional therapy versus therapeutic exercises in individuals with chronic shoulder pain: a randomized controlled trial

• Grant number: 25/01443-0
• Support Opportunities: Scholarships in Brazil - Doctorate (Direct)
• Start date: August 01, 2025
• End date: July 31, 2030
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Paula Rezende Camargo
• Grantee: Matheus Dias Gregorio
• Host Institution: Centro de Ciências Biológicas e da Saúde (CCBS). Universidade Federal de São Carlos (UFSCAR). São Carlos , SP, Brazil

Abstract

Introduction: Shoulder pain is the third most common musculoskeletal condition and a significant cause of morbidity and functional disability, associated with maladaptive pain behaviors such as kinesiophobia and catastrophizing. Exercise therapy is the first-line strategy, but emotional and social factors can hinder adherence and recovery. Cognitive functional therapy integrates biopsychosocial aspects and stands out as an effective intervention for other chronic musculoskeletal conditions. However, there is still no evidence of its effect on the treatment of chronic shoulder pain. Objective: This study is to determine whether cognitive functional therapy is superior to a therapeutic exercise protocol in reducing pain intensity, disability, patient-specific functionality, kinesiophobia, self-efficacy, sleep quality, treatment expectations, perception of change, and treatment satisfaction in individuals with chronic shoulder pain when compared to a therapeutic exercise protocol. Methods: This study is a randomized, controlled clinical trial. Ninety-two individuals of both sexes with shoulder pain for more than three months will participate and will be randomly assigned to two groups. Group 1 - Cognitive Functional Therapy - will receive a pragmatic intervention, lasting between 4 and 8 weeks, with a frequency of once per week. Group 2 - Therapeutic Exercises - will receive an exercise-based intervention for eight weeks, twice per week. The primary outcomes will be pain intensity (Numerical Pain Scale) and shoulder disability (Shoulder Pain and Disability Index). Secondary outcomes will include patient-specific functionality (Patient-Specific Functional Scale), kinesiophobia (Tampa Scale for Kinesiophobia), self-efficacy (Pain Self-Efficacy Questionnaire), sleep quality (Insomnia Severity Index), patient expectations regarding treatment (7-point Likert Scale), perception of change (Global Rating of Change Scale), and patient satisfaction (Global Rating of Change Scale). All outcomes will be measured at baseline, after 4 and 8 weeks of intervention, and 12 weeks after the end of the intervention. Statistical analysis will follow the intention-to-treat principle. Data analysis will be performed using the Statistical Package for Social Sciences (SPSS) software, version 24, SPSS Inc., Chicago, IL, version 26. Data normality will be assessed using the Kolmogorov-Smirnov test. Differences between groups will be analyzed using linear mixed models with group versus time interaction terms. Effect size will be calculated for between-group variables. The significance level will be set at 5%. Expected results: It is expected that cognitive functional therapy, by utilizing an individualized treatment focused on the biopsychosocial limitations of individuals with chronic shoulder pain, will be superior to treatment focused on muscle activation of the shoulder complex in improving pain intensity, shoulder disability, patient-specific functionality, kinesiophobia, self-efficacy, sleep quality, treatment expectations, perception of change, and treatment satisfaction. (AU)