Contextually Enhanced Exercise Programs for Rotator Cuff-Related Shoulder Pain

Condition(s) studied

Investigational drug(s) / intervention(s)

Contextually Fixed Exercise Program: This structured rehabilitation program includes progressive strengthening, mobility, and motor control exercises based on current clinical guidelines. Exercise dosage, progression criteria, and therapeutic targets are predefined and identical across groups. Environmental conditions, therapist communication style, and feedback are standardized and not individualized.

Contextually Enriched Personalized Exercise Program: This intervention includes the identical structured exercise program delivered twice weekly for 12 weeks with a home component. Exercise type, dosage, progression criteria, and therapeutic targets remain unchanged from the comparator group. Personalized contextual components are systematically integrated, including preferred music and lighting, autonomy-supportive communication, expectancy-enhancing feedback, and choice between biomechanically equivalent exercise alternatives targeting the same therapeutic objectives. These contextual elements do not modify exercise load or treatment goals.

Study summary

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

Primary outcome measure(s)

• QuickDASH — Baseline, 12 weeks, 24 weeks, and 52 weeks
  Upper-limb disability will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. The QuickDASH is an 11-item self-reported measure of physical function and symptoms. Total scores range from 0 to 100, with higher scores indicating greater disability. The primary endpoint will be the between-group difference in change from baseline scores.
• NPRS — Baseline, 12 weeks, 24 weeks, and 52 weeks
  Pain intensity will be assessed using the Numeric Pain Rating Scale (0 to 10 scale), where 0 indicates no pain and 10 indicates worst imaginable pain. Participants will rate their average shoulder pain over the previous 24 hours. The primary endpoint will be the between-group difference in change from baseline scores.
• Heart Rate Variability — Baseline, 2 weeks, 6 weeks, and 12 weeks
  Autonomic nervous system regulation will be assessed using heart rate variability metrics recorded during a standardized 5-minute resting condition. Primary parameters include the root mean square of successive differences (RMSSD) and high-frequency power components. The primary endpoint will be the between-group difference in change from baseline values.

Trial sites (1)

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