Cognitive Functional Therapy for Chronic Shoulder Pain: Pilot and Feasibility Study
Recruiting now · Not applicable
Conditions studied: Chronic Shoulder Pain, Exercise Therapy, Psychosocial Rehabilitation
In brief
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?
Key facts
- Study ID
- NCT06542666
- Run by
- Federal University of Paraíba
- People needed
- 24
- Starts
- 2025-02-17
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2025-02-18
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Federal University of Paraíba — João Pessoa, Paraíba, Brazil (enrolling)
Full record on ClinicalTrials.gov
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