Rotator Cuff Injuries, Rotator Cuff Related Shoulder Pain, Shoulder Pain
Conditions
Keywords
Rotator Cuff Injuries, Shoulder Pain, Contextual Healing, Placebo Effect, Exercise Therapy, Therapeutic Alliance, Treatment Adherence, Pain Catastrophizing, Kinesiophobia
Brief 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.
Detailed 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.
Interventions
BEHAVIORALContextually 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.
BEHAVIORALContextually 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.
Sponsors
Istanbul Nisantasi University
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors will be blinded to group allocation. Due to the nature of the intervention, the treating physiotherapist cannot be blinded. Intervention sessions for each group will be scheduled separately to minimize contamination.
Intervention model description
This is a two-arm, parallel-group randomized controlled trial. Participants will be allocated in a 1:1 ratio to either a contextually fixed exercise program or a contextually enriched and individualized exercise program. Randomization will be stratified by age and sex and implemented using permuted block randomization to ensure balanced group sizes. Allocation concealment will be maintained using sequentially numbered, sealed, opaque envelopes prepared by an independent research assistant. Both groups will receive the same core exercise protocol; the experimental group will additionally receive systematically integrated personalized contextual elements. There will be no crossover between groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tampa Scale for Kinesiophobia-11 | Baseline, 12 weeks, 24 weeks, and 52 weeks | Kinesiophobia will be assessed using the 11-item Tampa Scale for Kinesiophobia. Total scores range from 11 to 44, with higher scores indicating greater fear of movement. The endpoint will be the between-group difference in change from baseline scores. |
| Pain Catastrophizing Scale | Baseline, 12 weeks, 24 weeks, and 52 weeks | Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), a 13-item self-reported measure evaluating rumination, magnification, and helplessness related to pain. Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing (worse outcome). The endpoint will be the between-group difference in change from baseline scores. |
| Pain Self-Efficacy Questionnaire | Baseline, 12 weeks, 24 weeks, and 52 weeks | Pain self-efficacy will be measured using the Pain Self-Efficacy Questionnaire (PSEQ), a 10-item self-report measure assessing confidence in performing activities despite pain. Total scores range from 0 to 60, with higher scores indicating greater self-efficacy (better outcome).The endpoint will be the between-group difference in change from baseline scores. |
| Working Alliance Inventory-Short Revised | 6 weeks and 12 weeks | Therapeutic alliance will be assessed using the Working Alliance Inventory-Short Revised (WAI-SR), a 12-item questionnaire evaluating agreement on goals, tasks, and therapeutic bond. Total scores range from 12 to 60, with higher scores indicating a stronger therapeutic alliance (better outcome). The endpoint will be the between-group difference in change from baseline scores. |
| Exercise Adherence Rating Scale | 6 weeks and 12 weeks | Exercise adherence will be assessed using the Exercise Adherence Rating Scale (EARS), a 6-item self-reported measure evaluating adherence to prescribed exercise. Total scores range from 0 to 24, with higher scores indicating greater adherence (better outcome). The endpoint will be the between-group difference in change from baseline scores. |
Countries
Turkey (Türkiye)
Contacts
CONTACTOnur Atakan Sekibağ, PhD (c)
STUDY_CHAIRDerya ÇELİK, Professor of Physical Therapy
Istanbul University - Cerrahpasa
Outcome results
None listed