Actively Recruiting
Effects of Cognitive Functional Therapy Versus Therapeutic Exercises in Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial
Led by Universidade Federal de Sao Carlos · Updated on 2025-06-18
148
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether cognitive functional therapy is more effective than therapeutic exercises in reducing pain and disability for individuals with chronic shoulder pain. This randomized controlled trial includes 148 participants aged 18 to 65 years who have experienced shoulder pain for at least three months. The study aims to understand which treatment better improves pain, disability, function, and psychosocial factors related to shoulder pain. Participants will be randomly assigned to one of two groups. One group will receive cognitive functional therapy once a week for four to eight weeks, focusing on changing beliefs about pain, gradually exposing patients to movements, and promoting lifestyle changes. The other group will follow a therapeutic exercise program twice a week for eight weeks, targeting shoulder muscles with specific exercises using progressive resistance bands. Throughout the study, participants will undergo assessments at baseline, four weeks, eight weeks, and a 12-week follow-up. Researchers will measure pain intensity, shoulder disability, specific function, fear of movement, pain self-efficacy, sleep quality, treatment expectations, perception of change, treatment satisfaction, and exercise adherence. The study includes monitoring for safety, and participants may be discontinued if certain injuries or treatments occur during the trial.
CONDITIONS
Brief Title
Cognitive Functional Therapy Versus Exercises for Chronic Shoulder Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals of both sexes aged 18 to 65 years
- Shoulder pain lasting at least 3 months
- Pain intensity of at least 3 points on the Numeric Pain Rating Scale at rest or during arm movement
- Minimum score of 20 points on the Shoulder Pain and Disability Index (SPADI)
You will not qualify if you...
- Adhesive capsulitis with more than 50% loss of passive shoulder external rotation
- Previous shoulder surgery
- History of shoulder fracture
- Systemic musculoskeletal diseases such as rheumatoid arthritis or fibromyalgia
- Shoulder pain caused by cervical spine movement
- Signs of glenohumeral instability
- Self-reported systemic disease
- Positive drop arm test
- Pregnancy
- Active cancer treatment
- Neurological diseases
- Cognitive impairments
- Corticosteroid injection within 3 months before the study
- Physical therapy within 3 months before the study
- Fractures, surgeries, or musculoskeletal/neural injuries preventing treatment during study
- Receiving corticosteroid injections during treatment or follow-up period
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 8 weeks
Participants receive either Cognitive Functional Therapy once a week or Therapeutic Exercises twice a week targeting shoulder pain.
Weekly visits for Cognitive Functional Therapy or twice-weekly visits for Therapeutic Exercises over 8 weeks
Duration - 4 weeks after treatment completion
Participants are assessed for pain, disability, function, and treatment satisfaction after treatment ends.
1 visit (in-person) at 12 weeks after treatment start
Trial Site Locations
Total: 1 location
1
Universidade Federal de Sao Carlos
São Carlos, São Paulo, Brazil, 13568-110
Actively Recruiting
Research Team
M
Matheus Dias Gregorio
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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