Contextually Enriched Individualized Exercise Versus Contextually Fixed Exercise for Rotator Cuff-Related Shoulder Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIstanbul Nisantasi University

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

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Istanbul Nisantasi University

Lead sponsor

Istanbul University - Cerrahpasa

Collaborator