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

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:

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.

Conditions

• Rotator Cuff Related Shoulder Pain
• Shoulder Pain
• Rotator Cuff Injuries

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 therapeutic objectives. These contextual elements do not modify exercise load or treatment goals.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa

  collaborator OTHER

• Istanbul Nisantasi University

  lead OTHER

Principal Investigators

• Derya ÇELİK, Professor of Physical Therapy · Istanbul University - Cerrahpasa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-06

Primary Completion

2027-05-06

Completion

2028-05-06

Countries

• Turkey (Türkiye)

Study Locations