About this trial
The goal of this clinical trial is to learn whether adding personalized contextual factors to an exercise program can improve pain and function in people with rotator cuff-related shoulder pain. This condition is a common cause of shoulder pain and can limit daily activities.
The main questions this study aims to answer are:
1. Does a contextually enriched and individualized exercise program lead to greater improvement in upper-limb disability (measured by the QuickDASH questionnaire) compared with a contextually fixed program? 2. Does it lead to greater reductions in pain intensity (measured by the Numeric Pain Rating Scale) and greater improvements in autonomic nervous system regulation (measured by heart rate variability)? 3. Does it result in more favorable changes in psychosocial outcomes, exercise adherence, and therapeutic alliance?
Researchers will compare two exercise programs to determine whether adding personalized contextual features enhances treatment effectiveness.
One group will receive a standardized, evidence-based exercise program delivered in a fixed and neutral manner.
The other group will receive the same exercise program with added personalized contextual elements, such as:
* Preferred music and lighting * Choice between equivalent exercises (without changing exercise type or dosage) * Motivational feedback and supportive communication * Personalized progress tracking
Both groups will:
* Attend supervised exercise sessions twice per week for 12 weeks * Follow a structured home exercise program * Complete questionnaires assessing pain, function, and psychological factors * Undergo heart rate variability assessment to evaluate autonomic regulation * Be followed for 12 months after treatment
The researchers expect that integrating personalized contextual elements into exercise therapy may enhance recovery, increase motivation, and improve long-term outcomes.
Eligibility criteria
Qualifiers
Age between 18 and 75 years
Clinical diagnosis of rotator cuff-related shoulder pain
Shoulder pain duration longer than 3 months
Painful arc during shoulder flexion or abduction
Disqualifiers
Clinical signs of a large rotator cuff tear characterized by marked weakness without pain
Other shoulder conditions (e.g., frozen shoulder defined as at least 30 percent passive glenohumeral restriction in two or more directions, advanced osteoarthritis, fracture, dislocation, or severe acromioclavicular joint pathology)
Previous shoulder surgery
Neurological disorders or significant systemic diseases such as rheumatoid arthritis
Trial design
Treatments tested in this trial
- Contextually Fixed Exercise Program
- Contextually Enriched Personalized Exercise Program
Treatment groups
Locations
1Sponsors and collaborators
Istanbul Nisantasi University
Lead sponsor
Istanbul University - Cerrahpasa
Collaborator