NCT06661681

Cognitive Functional Therapy for Treating Individuals With Chronic Shoulder Pain

Cognitive Functional Therapy Versus Therapeutic Exercises for the Treatment of Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Federal University of Paraíba · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Shoulder pain is a debilitating musculoskeletal condition with functional, physical, and psychological impacts. Interventions for chronic shoulder pain should address the biopsychosocial model, with Cognitive Functional Therapy emerging as a promising physiotherapy approach. Cognitive Functional Therapy approaches the multidimensional nature of pain, integrating physical and cognitive aspects. The aim of this randomized controlled trial is to compare the effects of Cognitive Functional Therapy with therapeutic exercise on biological aspects of pain (pain intensity, disability, function, perception of improvement/deterioration, and central pain processing), and psychosocial aspects of pain (sleep quality, self-efficacy, and biopsychosocial factors). The hypothesis of this study is that CFT will lead to greater improvements in these outcomes compared to therapeutic exercise.

Detailed description

This will be a randomized controlled trial, single-blinded with two parallel groups. Seventy-two individuals with chronic shoulder pain will be randomly assigned to one of two groups: CFT or Therapeutic exercises. The interventions will last eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice weekly. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include function, self-efficacy, sleep quality, biopsychosocial factors, perception of improvement/deterioration, and central pain processing.

Conditions

• Chronic Shoulder Pain
• Exercise Therapy
• Psychosocial Rehabilitation

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Functional Therapy (CFT)	Cognitive Functional Therapy (CFT) is underpinned by a strong therapeutic alliance, active listening, and motivational interviewing style, covering the following domains: i) Making sense of pain involves discussing the multidimensional nature of persistent pain, as well as the beliefs, emotions, and behaviors that can perpetuate the vicious cycle of pain and disability. ii) Exposure with control involves a functional training designed to normalize maladaptive and provocative postural and movement behaviors, where individuals will learn strategies to improve their body awareness and control and modify postures and tasks commonly associated with pain. iii) Lifestyle change aims to help patients embrace a healthy lifestyle, which will include promoting a gradual increase in physical activity, sleep hygiene counseling, stress management strategies, and social re-engagement.
OTHER	Therapeutic exercises group	Each session will include stretching exercises targeting the following muscles i) Upper trapezius; ii) Pectoralis minor; iii) Posterior shoulder region, and strengthening exercises targeting the following muscles i) Lower trapezius, ii) Middle trapezius, iii) Serratus punch exercise, iv) Shoulder external rotators, and v) Shoulder internal rotators.

Timeline

• Start date: 2025-02-17
• Primary completion: 2026-06-25
• Completion: 2026-11-25
• First posted: 2024-10-28
• Last updated: 2025-02-19

Locations

1 site across 1 country: Brazil