Contextually Enriched Individualized Exercise Versus Contextually Fixed Exercise for Rotator Cuff-Related Shoulder Pain (CONTEXT-RCRSP)

Comparison of the Effectiveness of Contextually Enriched Exercise Programs in 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:

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Injuries; Shoulder Pain; Rotator Cuff Related Shoulder Pain
• Intervention / Treatment: Behavioral: Contextually Fixed Exercise Program; Behavioral: Contextually Enriched Personalized Exercise Program

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Onur Atakan Sekibağ, PhD (c); Phone Number: 90 (212) 210 10 10; Email: onuratakan.sekibag@nisantasi.edu.tr

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul Nisantasi University
    • Contact: Onu Atakan SEKİBAĞ, PhD(c). PT.; Phone Number: 90 (212) 210 10 10; Email: onuratakan.sekibag@nisantasi.edu.tr
    • Principal Investigator: Onur Atakan SEKİBAĞ, PhD(c). PT.
    • Principal Investigator: Derya ÇELİK, Professor of Physical Therapy
    • Sub-Investigator: Tolgahan KORKMAZ, Orthopedic Specialist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Contextually Fixed Exercise Program; 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; 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.
Experimental: Contextually Enriched Personalized 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, 2 weeks, 6 weeks, and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	6 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: Istanbul Nisantasi University
• Collaborators: Istanbul University - Cerrahpasa
• Investigators: Study Chair: Derya ÇELİK, Professor of Physical Therapy, Istanbul University - Cerrahpasa

Publications and helpful links

General Publications

• Rossettini 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.
• Testa 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.
• 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.
• Ferreira 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.
• Ezzatvar 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.
• Bisconti 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.
• Dube 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.
• Zhang 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 6, 2026
• Primary Completion (Estimated): May 6, 2027
• Study Completion (Estimated): May 6, 2028

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Shoulder Pain; Kinesiophobia; Pain Catastrophizing; Exercise Therapy; Treatment Adherence; Placebo Effect; Therapeutic Alliance; Rotator Cuff Injuries; Contextual Healing
• Additional Relevant MeSH Terms: Shoulder Injuries; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Mental Disorders; Wounds and Injuries; Joint Diseases; Rupture; Tendon Injuries; Arthralgia; Phobic Disorders; Anxiety Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Health Behavior; Rotator Cuff Injuries; Kinesiophobia; Shoulder Pain; Treatment Adherence and Compliance
• Other Study ID Numbers: OASPhD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 months after publication of the primary results and ending 5 years after publication.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No