Rotator Cuff Related Shoulder PainCONTEXT-RCRSPNCT07428070
Contextually Enhanced Exercise Programs for Rotator Cuff-Related Shoulder Pain
A study testing Contextually Fixed Exercise Program and Contextually Enriched Personalized Exercise Program in people with Rotator Cuff Related Shoulder Pain and Shoulder Pain, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rotator Cuff Related Shoulder Pain, Shoulder Pain, Rotator Cuff Injuries
- What is being tested?
- Contextually Fixed Exercise Program and Contextually Enriched Personalized Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2026to 6 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Nisantasi University
Istanbul
Onu Atakan SEKİBAĞ, PhD(c). PT., 90 (212) 210 10 10, onuratakan.sekibag@nisantasi.edu.tr
Onur Atakan SEKİBAĞ, PhD(c). PT.
About this study
Official title: Comparative Effectiveness of Contextually Enhanced Exercise Programs for Rotator Cuff-Related Shoulder Pain
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:
Read more
- 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?
- 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)?
- 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.
Read the 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.
- Being tested
- Contextually Fixed Exercise Program, Contextually Enriched Personalized Exercise Program
- Keywords
- Rotator Cuff Injuries, Shoulder Pain, Contextual Healing, Placebo Effect, Exercise Therapy, Therapeutic Alliance, Treatment Adherence, Pain Catastrophizing, Kinesiophobia
- Medical subject headings
- Shoulder Pain, Rotator Cuff Injuries, Treatment Adherence and Compliance, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contextually Fixed Exercise ProgramBehavioural
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.
Contextually Enriched Personalized Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Contextually Fixed Exercise Program | Active comparator | 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. Receives: Behavioral: Contextually Fixed Exercise Program |
| Contextually Enriched Personalized Exercise Program | Experimental | 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. Receives: Behavioral: Contextually Enriched Personalized Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 weeks, 6 weeks, and 12 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start6 May 2026
- Primary completion6 May 2027 (estimated)
- Study completion6 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Related Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Nisantasi University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Onur Atakan Sekibağ, Istanbul Nisantasi University
- Investigators
- Derya ÇELİK, Professor of Physical Therapy, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428070
- Sponsor's protocol ID
- OASPhD
- Acronym
- CONTEXT-RCRSP
- Status last verified
- Jul 2026
- First submitted
- 17 Feb 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Poulter D, Palese A, Rodeghiero L, Carlino E, Esteves JE, Cook C, Rossettini G. Contextual effects in musculoskeletal pain: are we overlooking essential factors? Front Psychol. 2025 Feb 17;16:1537242. doi: 10.3389/fpsyg.2025.1537242. eCollection 2025. No abstract available.
PubMed 40034938Rossettini G, Carlino E, Testa M. Clinical relevance of contextual factors as triggers of placebo and nocebo effects in musculoskeletal pain. BMC Musculoskelet Disord. 2018 Jan 22;19(1):27. doi: 10.1186/s12891-018-1943-8.
PubMed 29357856Ferreira PH, Ferreira ML, Maher CG, Refshauge KM, Latimer J, Adams RD. The therapeutic alliance between clinicians and patients predicts outcome in chronic low back pain. Phys Ther. 2013 Apr;93(4):470-8. doi: 10.2522/ptj.20120137. Epub 2012 Nov 8.
PubMed 23139428Ezzatvar Y, Duenas L, Balasch-Bernat M, Lluch-Girbes E, Rossettini G. Which Portion of Physiotherapy Treatments' Effect Is Not Attributable to the Specific Effects in People With Musculoskeletal Pain? A Meta-Analysis of Randomized Placebo-Controlled Trials. J Orthop Sports Phys Ther. 2024 Jun;54(6):391-399. doi: 10.2519/jospt.2024.12126.
PubMed 38602164Bisconti M, Venturin D, Bianco A, Capurso V, Giovannico G. Understanding Contextual Factors Effects and Their Implications for Italian Physiotherapists: Findings from a National Cross-Sectional Study. Healthcare (Basel). 2021 Jun 7;9(6):689. doi: 10.3390/healthcare9060689.
PubMed 34200302Testa M, Rossettini G. Enhance placebo, avoid nocebo: How contextual factors affect physiotherapy outcomes. Man Ther. 2016 Aug;24:65-74. doi: 10.1016/j.math.2016.04.006. Epub 2016 Apr 20.
PubMed 27133031Dube MO, Desmeules F, Lewis J, Roy JS. Rotator cuff-related shoulder pain: does the type of exercise influence the outcomes? Protocol of a randomised controlled trial. BMJ Open. 2020 Nov 5;10(11):e039976. doi: 10.1136/bmjopen-2020-039976.
PubMed 33154058Zhang W, Du M, Xia L, Hao F, Tian M. Effects of seven types of exercise in the treatment of rotator cuff-related shoulder pain (RCRSP): a systematic review and Bayesian network meta-analysis. J Orthop Surg Res. 2025 Nov 23;20(1):1075. doi: 10.1186/s13018-025-06514-4.
PubMed 41276811
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Contextually Enhanced Exercise Programs for Rotator Cuff-Related Shoulder Pain
- ClinicalTrials.gov ID
- NCT07428070
- Acronym / sponsor ID
- CONTEXT-RCRSP / OASPhD
- Keywords
- Rotator Cuff Injuries, Shoulder Pain, Contextual Healing, Placebo Effect, Exercise Therapy, Therapeutic Alliance, Treatment Adherence, Pain Catastrophizing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Istanbul Nisantasi UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 6 May 2026 (actual)
- Primary completion
- 6 May 2027 (estimated)
- Study completion
- 6 May 2028 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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)?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Contextually Fixed Exercise Program | Active comparator | Behavioral: Contextually Fixed Exercise ProgramParticipants 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. |
| Contextually Enriched Personalized Exercise Program | Experimental | Behavioral: Contextually Enriched Personalized Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contextually Fixed Exercise ProgramThis 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. | Behavioural | Contextually Fixed Exercise Program |
| Contextually Enriched Personalized Exercise ProgramThis 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. | Behavioural | Contextually Enriched Personalized Exercise Program |
Primary outcome
QuickDASH
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
Tampa Scale for Kinesiophobia-11
Time frame: Baseline, 12 weeks, 24 weeks, and 52 weeks
Pain Catastrophizing Scale
Time frame: Baseline, 12 weeks, 24 weeks, and 52 weeks
Pain Self-Efficacy Questionnaire
Time frame: Baseline, 12 weeks, 24 weeks, and 52 weeks
Working Alliance Inventory-Short Revised
Time frame: 6 weeks and 12 weeks
Exercise Adherence Rating Scale
Time frame: 6 weeks and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 40034938Poulter D, Palese A, Rodeghiero L, Carlino E, Esteves JE, Cook C, Rossettini G. Contextual effects in musculoskeletal pain: are we overlooking essential factors? Front Psychol. 2025 Feb 17;16:1537242. doi: 10.3389/fpsyg.2025.1537242. eCollection 2025. No abstract available.
- Background: PubMed 29357856Rossettini G, Carlino E, Testa M. Clinical relevance of contextual factors as triggers of placebo and nocebo effects in musculoskeletal pain. BMC Musculoskelet Disord. 2018 Jan 22;19(1):27. doi: 10.1186/s12891-018-1943-8.
- Background: PubMed 23139428Ferreira PH, Ferreira ML, Maher CG, Refshauge KM, Latimer J, Adams RD. The therapeutic alliance between clinicians and patients predicts outcome in chronic low back pain. Phys Ther. 2013 Apr;93(4):470-8. doi: 10.2522/ptj.20120137. Epub 2012 Nov 8.
- Background: PubMed 38602164Ezzatvar Y, Duenas L, Balasch-Bernat M, Lluch-Girbes E, Rossettini G. Which Portion of Physiotherapy Treatments' Effect Is Not Attributable to the Specific Effects in People With Musculoskeletal Pain? A Meta-Analysis of Randomized Placebo-Controlled Trials. J Orthop Sports Phys Ther. 2024 Jun;54(6):391-399. doi: 10.2519/jospt.2024.12126.
- Background: PubMed 34200302Bisconti M, Venturin D, Bianco A, Capurso V, Giovannico G. Understanding Contextual Factors Effects and Their Implications for Italian Physiotherapists: Findings from a National Cross-Sectional Study. Healthcare (Basel). 2021 Jun 7;9(6):689. doi: 10.3390/healthcare9060689.
- Background: PubMed 27133031Testa M, Rossettini G. Enhance placebo, avoid nocebo: How contextual factors affect physiotherapy outcomes. Man Ther. 2016 Aug;24:65-74. doi: 10.1016/j.math.2016.04.006. Epub 2016 Apr 20.
- Background: PubMed 33154058Dube MO, Desmeules F, Lewis J, Roy JS. Rotator cuff-related shoulder pain: does the type of exercise influence the outcomes? Protocol of a randomised controlled trial. BMJ Open. 2020 Nov 5;10(11):e039976. doi: 10.1136/bmjopen-2020-039976.
- Background: PubMed 41276811Zhang W, Du M, Xia L, Hao F, Tian M. Effects of seven types of exercise in the treatment of rotator cuff-related shoulder pain (RCRSP): a systematic review and Bayesian network meta-analysis. J Orthop Surg Res. 2025 Nov 23;20(1):1075. doi: 10.1186/s13018-025-06514-4.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Derya ÇELİK, Professor of Physical Therapy study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contextually Fixed Exercise Program and Contextually Enriched Personalized Exercise Program in people with Rotator Cuff Related Shoulder Pain and Shoulder Pain, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Onur Atakan Sekibağ, PhD (c) (90 (212) 210 10 10, onuratakan.sekibag@nisantasi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QuickDASH (time frame: Baseline, 12 weeks, 24 weeks, and 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07428070, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.