NCT06542666 Cognitive Functional Therapy for Chronic Shoulder Pain: Pilot and Feasibility Study
| NCT ID | NCT06542666 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal University of Paraíba |
| Condition | Chronic Shoulder Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-02-17 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This pilot randomized controlled clinical trial (RCT) will assess the feasibility and identify the key components necessary for conducting the main RCT, which will involve the comparison of Cognitive Functional Therapy with Therapeutic Exercises in individuals with chronic shoulder pain. The main questions it aims to answer are: * What barriers to the participation of the included individuals might arise? * Will the assessment procedures and outcome measures be feasible and suitable? * What time will be necessary to conduct the assessments? * Will participants be willing to be randomized to the proposed treatment groups? * What barriers to the clinical delivery of Cognitive Functional Therapy in the healthcare system might exist? * Will the treatment(s) be acceptable to patients? * Will participants adhere to the treatment? * What will the recruitment rates be per week/month? * Will there be any selection bias? * Will participant retention be high among the allocation groups? * Will the data be complete? * What will the data variability be? * Will the treatment effects/outcomes be consistent with expectations and previous literature?
Eligibility Criteria
Inclusion Criteria: * Men and women; * Age between 18 and 60 years; * Presence of shoulder pain for more than 3 months; * Pain intensity of 4 points or more on the 11-point Numeric Pain Rating Scale during the past week. * High level of disability or moderate level of irritability. Exclusion Criteria: * History of fracture or surgery of the clavicle, scapula, and/or humerus, surgical stabilization or rotator cuff repair; * History of dislocation, instability (positive sulcus sign or apprehension test), and/or rotator cuff tear (positive drop arm test); * Adhesive capsulitis verified by the presence of gradual onset pain associated with stiffness and reduced passive and active mobility; * Ongoing pregnancy; * Reproduction of shoulder pain radiating to the entire upper limb during cervical or thoracic spine tests (positive Spurling test); * Neurological or systemic diseases that may alter muscle strength and sensitivity such as rheumatoid arthritis, fibromyalgia, lupus, gout, and diabetes; * Corticosteroid injection in the shoulder region in the last 3 months; * Physiotherapy treatment in the last 6 months.
Contact & Investigator
VALÉRIA MA OLIVEIRA, PhD
PRINCIPAL INVESTIGATOR
Universidade Federal da Paraíba
Frequently Asked Questions
Who can join the NCT06542666 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Chronic Shoulder Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06542666 currently recruiting?
Yes, NCT06542666 is actively recruiting participants. Contact the research team at valeria.mayaly@gmail.com for enrollment information.
Where is the NCT06542666 trial being conducted?
This trial is being conducted at João Pessoa, Brazil.
Who is sponsoring the NCT06542666 clinical trial?
NCT06542666 is sponsored by Federal University of Paraíba. The principal investigator is VALÉRIA MA OLIVEIRA, PhD at Universidade Federal da Paraíba. The trial plans to enroll 24 participants.