An interventional study of Contextually Fixed Exercise Program and Contextually Enriched Personalized Exercise Program in Rotator Cuff Related Shoulder Pain, Shoulder Pain and Rotator Cuff Injuries, sponsored by Istanbul Nisantasi University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Istanbul Nisantasi University · Not applicable, Interventional, and Treatment
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:
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:
Both groups will:
The researchers expect that integrating personalized contextual elements into exercise therapy may enhance recovery, increase motivation, and improve long-term outcomes.
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:
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:
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.
735 studies on the registry are indexed under Shoulder Pain; 167 are open to participants now.
This study's planned enrollment of 72 is above the median of 60 across 587 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Istanbul Nisantasi University is the lead sponsor of 21 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a standardized, evidence-based exercise program for rotator cuff-related shoulder pain delivered twice weekly for 12 weeks, with a structured home exercise component. Contextual elements, including environmental conditions and therapist communication, will be delivered in a fixed, neutral, and standardized manner without personalization.
Behavioral: Contextually Fixed Exercise Program
Participants will receive the same evidence-based exercise program delivered twice weekly for 12 weeks, with a structured home exercise component. Exercise dosage, progression, and therapeutic targets will be identical to the comparator group. In addition, personalized contextual elements will be systematically integrated.
Behavioral: Contextually Enriched Personalized 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.
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.
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
Exercise Adherence Rating Scale
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.
Time frame: 6 weeks and 12 weeks
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request. Shared data will include demographic variables, primary and secondary outcome measures, and relevant clinical variables. Data will be available beginning 6 months following publication and will remain available for 5 years. Access will be granted to researchers who provide a methodologically sound proposal and agree to a data use agreement. Requests should be directed to the corresponding investigator.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning 6 months after publication of the primary results and ending 5 years after publication.
Access criteria: De-identified individual participant data (IPD), including demographic variables, primary and secondary outcome data, and relevant clinical variables, will be made available to qualified researchers upon reasonable request. Supporting documents, including the study protocol, statistical analysis plan, and analytic code, will also be accessible. Access will be granted to researchers who provide a methodologically sound research proposal and sign a data use agreement to ensure appropriate data handling and confidentiality. Requests will be reviewed by the principal investigator. Data will be shared through a secure data transfer method after approval of the request. Interested researchers should contact the corresponding investigator by email to initiate the request process.
Started May 2026 (actual). Primary completion is estimated for May 2027, 12 months after the start.
Of 349 non-industry interventional studies with no phase under Shoulder Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 12 months is close to that.
Counting every sponsor, half of 354 studies reached it within 11 months; a quarter within 4 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
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Istanbul Nisantasi University