Overview
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:
- 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?
- 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)?
- 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.
Description
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.
Eligibility
Inclusion Criteria:
- 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
- Positive Neer or Hawkins-Kennedy test
- Pain during resisted external rotation or abduction, or positive Jobe test
- Ability to understand and speak Turkish
- Willingness to participate and provide informed consent
Exclusion Criteria:
- 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
- Current or past history of malignancy
- Physical or cognitive impairments preventing participation in assessments or intervention sessions
- Reproduction of shoulder symptoms with active cervical spine movements indicating symptomatic cervical pathology
- Corticosteroid injection within the previous 6 weeks
- Participation in other concurrent shoulder treatments during the study
