Movement-and-thinking therapy versus exercise for chronic shoulder pain

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

This study will test whether a program that combines movement retraining and changing pain-related beliefs (cognitive functional therapy) helps adults with chronic shoulder pain more than a standard therapeutic exercise program.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Universidade Federal de Sao Carlos (other)
• Locations: 1 site (São Carlos, São Paulo)
• Trial ID: NCT06854809 on ClinicalTrials.gov

What this trial studies

This single-blind, randomized controlled trial will enroll 148 adults with chronic shoulder pain and randomly assign them to two parallel groups. One group will receive cognitive functional therapy (4–8 weekly sessions), while the other follows a therapeutic exercise protocol delivered twice weekly for eight weeks. Primary outcomes are pain intensity and disability, and secondary outcomes include shoulder-specific function, kinesiophobia, self-efficacy, sleep quality, treatment expectations, perceived change, satisfaction, and exercise adherence. Outcomes will be measured before and after the intervention period to compare effects between the two approaches.

Who should consider this trial

Good fit: Adults aged 18–65 with shoulder pain lasting at least three months who report pain of at least 3/10 on the Numeric Pain Rating Scale and have a SPADI score of 20 or higher.

Not a fit: People with adhesive capsulitis, prior shoulder surgery or fracture, systemic musculoskeletal disease, cervical-referred shoulder pain, signs of glenohumeral instability, pregnancy, active cancer, or other exclusion conditions are unlikely to be eligible and may not benefit from these interventions.

Why it matters

Potential benefit: If successful, the approach could reduce pain and disability and improve daily shoulder function and coping for people with chronic shoulder pain.

How similar studies have performed: Cognitive functional therapy has shown promising benefits for chronic low back pain, but its application to chronic shoulder pain is less tested and remains relatively novel.

Eligibility criteria

Inclusion Criteria:

Individuals of both sexes, aged between 18 and 65 years, will be included if they have had shoulder pain for at least 3 months and report a pain intensity of at least 3 points on the Numeric Pain Rating Scale (NPRS) at rest or during arm movement. Additionally, they must have a minimum score of 20 points on the Shoulder Pain and Disability Index (SPADI).

Exclusion Criteria:

Individuals will not be included if they have adhesive capsulitis, defined as a loss of more than 50% of passive shoulder range of motion in external rotation; previous shoulder surgery; a history of shoulder fracture; systemic musculoskeletal diseases (e.g., rheumatoid arthritis, fibromyalgia); shoulder pain reproduced by active or passive cervical spine movement; signs of glenohumeral instability identified by a positive sulcus test or a positive apprehension test indicating laxity in the glenohumeral joint; self-reported systemic disease; a positive drop arm test; pregnancy; active cancer treatment; neurological diseases; cognitive impairments; corticosteroid injection within three months prior to the intervention; or physical therapy in the three months preceding the study.

Participants will be discontinued from the study if they experience fractures, surgeries, musculoskeletal or neural injuries that prevent access to treatment, or receive corticosteroid injections during the treatment or follow-up period.

Where this trial is running

São Carlos, São Paulo

• Universidade Federal de Sao Carlos — São Carlos, São Paulo, Brazil (RECRUITING)

Study contacts

• Study coordinator: Matheus Dias Gregorio

Conditions: Chronic Shoulder Pain, shoulder pain, Psychosocial Rehabilitation, exercise therapy