Contextually Enriched Individualized Exercise Versus Contextually Fixed Exercise for Rotator Cuff-Related Shoulder Pain

NCT07428070 | Not Yet Recruiting

• 1 other identifier: OASPhD
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.

Conditions

Rotator Cuff Related Shoulder Pain; Shoulder Pain; Rotator Cuff Injuries

Keywords

Rotator Cuff Injuries; Shoulder Pain; Contextual Healing; Placebo Effect; Exercise Therapy; Therapeutic Alliance; Treatment Adherence; Pain Catastrophizing; Kinesiophobia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Tampa Scale for Kinesiophobia-11

  Baseline, 12 weeks, 24 weeks, and 52 weeks

• Pain Catastrophizing Scale

  Baseline, 12 weeks, 24 weeks, and 52 weeks

• Pain Self-Efficacy Questionnaire

  Baseline, 12 weeks, 24 weeks, and 52 weeks

• Working Alliance Inventory-Short Revised

  6 weeks and 12 weeks

• Exercise Adherence Rating Scale

  6 weeks and 12 weeks

Study Arms (2)

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.

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.

Behavioral: Contextually Enriched Personalized Exercise Program

Interventions

Contextually Fixed Exercise Program BEHAVIORAL

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 Fixed Exercise Program

Contextually Enriched Personalized Exercise Program BEHAVIORAL

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.

Contextually Enriched Personalized Exercise Program

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: collaborator
• Istanbul Nisantasi University: lead

Study Sites (1)

İstanbul Nisantasi University

Istanbul, Turkey (Türkiye)

Location

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Rotator Cuff Injuries; Treatment Adherence and Compliance; Kinesiophobia

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Health Behavior; Behavior; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Derya ÇELİK, Professor of Physical Therapy

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Central Study Contacts

Onur Atakan Sekibağ, PhD (c)

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group allocation. Due to the nature of the intervention, the treating physiotherapist cannot be blinded. Intervention sessions for each group will be scheduled separately to minimize contamination.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Physical Therapist

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): May 6, 2027
• Study Completion (Estimated): May 6, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

TU (1)