Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

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

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

Run by Universidade Federal de Sao Carlos · NCT06854809 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment148 (estimated)
SponsorUniversidade Federal de Sao Carlos
Academic / other
Locations1 site (São Carlos, São Paulo)
StatusRecruiting
StartedJuly 2025
Main results expectedJune 2027
Study endsMarch 2029
Registry record updatedJune 18, 2025
Trial IDNCT06854809 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Universidade Federal de Sao Carlos
    São Carlos, São Paulo, Brazil
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.