RecruitingNot Applicable

Contextually Enhanced Exercise Programs for Rotator Cuff-Related Shoulder Pain

Turkey (Türkiye)72 participantsStarted 2026-05-06

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

QuickDASH

Timeframe: Baseline, 12 weeks, 24 weeks, and 52 weeks

NPRS

Timeframe: Baseline, 12 weeks, 24 weeks, and 52 weeks

Heart Rate Variability

Timeframe: Baseline, 2 weeks, 6 weeks, and 12 weeks

Trial details

NCT IDNCT07428070

SponsorIstanbul Nisantasi University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-06

Contact for this trial

Onur Atakan Sekibağ, PhD (c)

90 (212) 210 10 10 onuratakan.sekibag@nisantasi.edu.tr

View on ClinicalTrials.gov More Rotator Cuff Related Shoulder Pain trials