Cognitive Functional Therapy Versus Therapeutic Exercises for Treating Individuals With Chronic Shoulder Pain: A Pilot and Feasibility Study
Led by Federal University of Paraíba · Updated on 2025-02-18
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4 weeks
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What this Trial Is About
Researchers are evaluating the feasibility of conducting a larger randomized controlled trial comparing Cognitive Functional Therapy (CFT) with therapeutic exercises for individuals suffering from chronic shoulder pain. This pilot study aims to identify potential barriers to participation, assess the suitability of assessment methods and outcome measures, and understand recruitment, retention, and adherence rates among participants. The study focuses on the biopsychosocial aspects of chronic shoulder pain, which affects physical function and psychological well-being.
The study involves two groups: one receiving Cognitive Functional Therapy through weekly individual in-person sessions lasting about 40 minutes over eight weeks, and the other performing strengthening and stretching exercises twice a week for eight weeks, with each session lasting 30 to 40 minutes. CFT addresses maladaptive cognitive, physical, and lifestyle behaviors contributing to pain, including pain education, functional training, daily activity integration, and lifestyle counseling. The exercise group focuses on targeted stretching and strengthening of shoulder-related muscles using resistance bands.
Participants will undergo assessments at baseline, 4 weeks, and after 8 weeks of treatment, including measures of pain intensity, disability, self-efficacy, fear of movement, catastrophizing, sleep quality, biopsychosocial factors, treatment expectations, and functional ability. Researchers will monitor recruitment and retention rates and evaluate the acceptability of interventions. The total study duration for participants is eight weeks, during which adherence and treatment effects will be observed and recorded.
CONDITIONS
Brief Title
Cognitive Functional Therapy for Chronic Shoulder Pain: Pilot and Feasibility Study
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
Men and women
Age between 18 and 60 years
Shoulder pain lasting more than 3 months
Pain intensity of 4 or more on the 11-point Numeric Pain Rating Scale during the past week
High level of disability or moderate level of irritability
You will not qualify if you...
History of fracture or surgery of the clavicle, scapula, or humerus, including surgical stabilization or rotator cuff repair
History of shoulder dislocation, instability, or rotator cuff tear
Adhesive capsulitis with gradual onset pain and stiffness
Ongoing pregnancy
Shoulder pain radiating to the entire upper limb during spine tests
Neurological or systemic diseases affecting muscle strength and sensitivity such as rheumatoid arthritis, fibromyalgia, lupus, gout, and diabetes
Corticosteroid injection in the shoulder region within the last 3 months
Physiotherapy treatment in the last 6 months
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants receive either Cognitive Functional Therapy or therapeutic exercises for chronic shoulder pain. Cognitive Functional Therapy involves weekly individual sessions lasting about 40 minutes each, focusing on pain understanding, controlled exposure, and lifestyle changes. Therapeutic exercises involve stretching and strengthening performed twice a week for about 30 to 40 minutes per session.
Weekly visits for Cognitive Functional Therapy or twice-weekly exercise sessions
Cognitive functional therapy versus therapeutic exercises for the treatment of individuals with chronic shoulder pain: A protocol for a randomized controlled trial.
Vander Gava, Jessica Mayara da Silva Eugenio, Ney Meziat-Filho...