Contextually Enhanced Exercise Programs for Rotator Cuff-Related Shoulder Pain

Official title

Comparative Effectiveness of Contextually Enhanced Exercise Programs for Rotator Cuff-Related Shoulder Pain

Overview

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.

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.

Interventions

• 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.
• 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

Primary outcome measures

• QuickDASH [Time frame: Baseline, 12 weeks, 24 weeks, and 52 weeks]
• NPRS [Time frame: Baseline, 12 weeks, 24 weeks, and 52 weeks]
• Heart Rate Variability [Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks]

Secondary outcome measures (5)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• İstanbul Nisantasi University — Istanbul

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. PMID 40034938
• 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. PMID 29357856
• 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. PMID 23139428
• 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. PMID 38602164
• 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. PMID 34200302
• 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. PMID 27133031
• 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. PMID 33154058
• 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. PMID 41276811

Identifiers

NCT: NCT07428070 · OASPhD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗