Rotator cuff-related shoulder pain (RCRSP) is a prevalent musculoskeletal condition associated with persistent pain, functional limitations, and psychosocial burden. Exercise therapy is widely recommended as a first-line intervention; however, individual responses vary considerably. Growing evidence suggests that contextual factors (including therapeutic alliance, communication style, environmental cues, patient expectations, and perceived meaning) may influence treatment outcomes through neurophysiological and psychosocial pathways.
This randomized controlled trial evaluates whether systematically enriching contextual factors within an evidence-based exercise program improves clinical and psychophysiological outcomes in individuals with RCRSP.
The study is grounded in biopsychosocial and contextual healing frameworks. Contextual modulation is hypothesized to influence outcomes through mechanisms such as:
- Expectation-driven modulation of pain perception
- Alterations in autonomic nervous system activity
- Enhanced motivation and treatment adherence
- Strengthened therapeutic alliance
This is a two-arm, parallel-group randomized controlled trial. Participants will be allocated in a 1:1 ratio using stratified block randomization to ensure balance across age and sex categories. Allocation concealment will be maintained using sequentially numbered, sealed, opaque envelopes prepared by an independent research assistant not involved in assessment procedures.
Both groups will receive the same structured, guideline-based exercise program delivered over a 12-week supervised period. Exercise type, dosage, progression criteria, and therapeutic targets will be identical between groups. The only difference will be the systematic integration of personalized contextual elements in the experimental arm.
In the contextually enriched group, contextual integration will include:
- Tailored environmental features (e.g., preferred music and lighting)
- Choice among biomechanically equivalent exercise alternatives targeting the same therapeutic objectives
- Autonomy-supportive communication and expectancy-enhancing feedback
- Personalized progress tracking and reinforcement strategies
Importantly, exercise load parameters, progression thresholds, and biomechanical targets will not differ between groups. This design allows isolation of the effect of contextual enrichment independent of exercise content.
Blinding will be applied to outcome assessors and participants regarding group allocation. Due to the nature of the intervention, the treating physiotherapist cannot be blinded. To minimize contamination, group sessions will be scheduled separately.
The intervention period will last 12 weeks, followed by follow-up assessments extending to 12 months. This allows evaluation of both short-term treatment response and long-term maintenance effects.
In addition to patient-reported outcomes, autonomic nervous system regulation will be assessed using heart rate variability metrics obtained under standardized resting conditions. This provides objective insight into potential neurobiological mechanisms associated with contextual modulation.
By isolating contextual components while maintaining identical exercise content, this trial aims to determine whether structured personalization enhances rehabilitation outcomes beyond exercise therapy alone. Findings may inform future physiotherapy practice by integrating evidence-based contextual strategies into standard exercise-based rehabilitation.