NCT06854809

Cognitive Functional Therapy Versus Exercises for Chronic Shoulder Pain

Effects of Cognitive Functional Therapy Versus Therapeutic Exercises in Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Universidade Federal de Sao Carlos · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical trial is to determine whether cognitive functional therapy is superior to therapeutic exercises for the treatment of chronic shoulder pain. The main questions it aims to answer are: Is cognitive functional therapy superior to therapeutic exercises for pain and disability in individuals with chronic shoulder pain? Is cognitive functional therapy superior to therapeutic exercises for functionality and psychosocial factors? Participants will: Receive 4 to 8 sessions of cognitive functional therapy once a week for four to eight weeks. Follow a therapeutic exercise protocol for eight weeks with a frequency of twice per week.

Detailed description

This will be a randomized controlled trial, single-blind, with two parallel groups. 148 individuals with chronic shoulder pain will be randomly assigned to one of two groups: Cognitive functional therapy (CFT) or therapeutic exercises. The interventions will last between four and eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice a week for eight weeks. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include specific function, kinesiophobia, self-efficacy, sleep quality, treatment expectations, perception of change, treatment satisfaction and exercise adherence.

Conditions

• Chronic Shoulder Pain

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive functional therapy	The intervention consists of a Cognitive-Functional Therapy (CFT) program for individuals with shoulder pain, conducted by trained physiotherapists (106 hours of training) under the supervision of an expert with over 8 years of experience. CFT adopts a biopsychosocial approach and is structured into three main components: Making Sense of Pain - A cognitive component aimed at reinterpreting dysfunctional beliefs about pain through a reflective process based on the patient's life history, promoting understanding and self-efficacy. Graded Exposure with Control - Gradual exposure to functional activities, aiming to modify maladaptive associations between movement and pain, fostering the development of movement confidence. Lifestyle Change - Discussion and implementation of strategies to promote a healthy lifestyle, including physical activity, sleep habits, and stress management. All three components are integrated from the first session, with initial focus on building the therapeutic all.
OTHER	Therapeutic exercise	Participants in the Therapeutic Exercises Group will engage in individualized exercises targeting the scapulothoracic musculature and rotator cuff. The exercises, performed bilaterally, include lateral arm rotation, T, W, wall hand slide, and diagonal arm movement upwards. Each participant will be guided by one of two physiotherapists, randomly assigned. The exercises will follow a protocol consisting of 3 sets of 12 repetitions, with 1-minute rest between sets, using progressively resistant Thera-Bands®. Resistance will increase when pain is ≤2 on the Numerical Rating Scale and perceived exertion is \<3 on the Borg Scale. The protocol was designed based on scientific literature and shoulder pain treatment guidelines to address muscle activation deficits and rotator cuff and scapulothoracic imbalances.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-06-01
• Completion: 2029-03-01
• First posted: 2025-03-03
• Last updated: 2025-06-18

Locations

1 site across 1 country: Brazil