Contextually Enhanced Exercise Programs for Rotator Cuff-Related Shoulder Pain
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Contextually Fixed Exercise Program
BehavioralThis 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
BehavioralThis 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Contextually Fixed Exercise ProgramActive comparator 1 intervention
Group B: Contextually Enriched Personalized Exercise ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
QuickDASH
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.
Time frame
Baseline, 12 weeks, 24 weeks, and 52 weeks2
NPRS
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.
Time frame
Baseline, 12 weeks, 24 weeks, and 52 weeks3
Heart Rate Variability
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.
Time frame
Baseline, 2 weeks, 6 weeks, and 12 weeksSecondary outcomes
1
Tampa Scale for Kinesiophobia-11
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.
Time frame
Baseline, 12 weeks, 24 weeks, and 52 weeks2
Pain Catastrophizing Scale
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.
Time frame
Baseline, 12 weeks, 24 weeks, and 52 weeks3
Pain Self-Efficacy Questionnaire
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.
Time frame
Baseline, 12 weeks, 24 weeks, and 52 weeks4
Working Alliance Inventory-Short Revised
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.
Time frame
6 weeks and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istanbul Nisantasi University
Lead sponsor
Istanbul University - Cerrahpasa
Collaborator
Source ClinicalTrials.gov