NCT07428070 Contextually Enhanced Exercise Programs for Rotator Cuff-Related Shoulder Pain
| NCT ID | NCT07428070 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul Nisantasi University |
| Condition | Rotator Cuff Related Shoulder Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2026-05-06 |
| Primary Completion | 2027-05-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2026-05-06 with a primary completion date of 2027-05-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Derya ÇELİK, Professor of Physical Therapy
STUDY CHAIR
Istanbul University - Cerrahpasa
Frequently Asked Questions
Who can join the NCT07428070 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rotator Cuff Related Shoulder Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07428070 currently recruiting?
Yes, NCT07428070 is actively recruiting participants. Contact the research team at onuratakan.sekibag@nisantasi.edu.tr for enrollment information.
Where is the NCT07428070 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07428070 clinical trial?
NCT07428070 is sponsored by Istanbul Nisantasi University. The principal investigator is Derya ÇELİK, Professor of Physical Therapy at Istanbul University - Cerrahpasa. The trial plans to enroll 72 participants.