The Effect of an Exercise Program Based on Attentional Focus Shifting on Clinical Outcomes in Rotator Cuff Related Shoulder Pain

The aim of this clinical trial is to investigate the effects of an attention shift-based rehabilitation program on clinical outcomes in individuals with rotator cuff-related shoulder pain (RCRSP). The study will evaluate the effects of an attention shift approach, in which motor tasks targeting regions outside the shoulder are performed concurrently with standard shoulder exercises, on pain, functional status, and pain catastrophizing. These results will be compared with those of a standard shoulder rehabilitation program.

The main questions this study aims to answer are:

Is there a difference in pain levels between individuals with RCRSP who participate in an attention shift-based rehabilitation program and those who participate in a standard exercise program? Is there a difference between these two rehabilitation approaches in terms of shoulder function and pain catastrophizing?

Participants will:

Be randomly assigned to either an attention shift-based rehabilitation group or a standard shoulder rehabilitation group Participate in supervised exercise sessions twice per week for 6 weeks Attend sessions lasting approximately 60-75 minutes Undergo clinical assessments at baseline and at week 6

Study Overview

• Status: Recruiting
• Conditions: Subacromial Pain Syndrome; Shoulder Bursitis; Shoulder Tendinopathy; Rotator Cuff Tears of the Shoulder; Rotator Cuff Related Shoulder Pain
• Intervention / Treatment: Other: Patient Education; Other: Attention Shift-Based Exercise Therapy; Other: Standard Exercise Therapy

Detailed Description

A total of 46 participants will be included in the study based on the results of a priori power analysis. This study is designed as a randomized, parallel-group clinical trial. Participants diagnosed with rotator cuff-related shoulder pain (RCRSP) will be randomly allocated into two groups using a computer-generated randomization program: the Attention Shift-Based Rehabilitation Group (Group 1) and the Standard Rehabilitation Group (Group 2).

Both groups will receive standardized patient education and participate in a supervised exercise program. The Standard Rehabilitation Group will undergo a structured shoulder rehabilitation program consisting of range of motion, stretching, and strengthening exercises.

In the Attention Shift-Based Rehabilitation Group, participants will perform the same exercise program concurrently with additional motor tasks targeting body regions outside the shoulder (e.g., lower extremity or contralateral limb movements). These concurrent tasks are designed to shift attentional focus away from the painful shoulder region during exercise performance.

The intervention will be administered twice per week for a total of 12 sessions over a 6-week period. Each session will last approximately 60-75 minutes and will be supervised by a physiotherapist to ensure proper execution and adherence.

Assessments will be conducted at baseline (pre-intervention), at the end of the 6-week intervention period, and at 12 weeks as a follow-up assessment.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rezzan Atay, Bachelor's degree; Phone Number: 90+ 505 485 75 49; Email: rezzan.atay@ogr.iuc.edu.tr

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Istanbul University-Cerrahpaşa

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Having symptoms persisting for at least 3 months
• Experiencing pain intensity of at least 3 on the Numeric Pain Rating Scale (NPRS) during activity
• Presence of a painful arc during shoulder flexion or abduction
• Positive Neer test or Hawkins-Kennedy test
• Pain provoked by resisted external rotation/abduction of the humerus, or a positive Jobe (Empty Can) test
• Having a clinical diagnosis of subacromial pain syndrome, rotator cuff tendinopathy, subacromial bursitis, or symptomatic partial/full-thickness rotator cuff tear
• Being able to understand and complete questionnaires in Turkish

Exclusion Criteria:

• Presence of adhesive capsulitis (≥30% limitation in passive range of motion)
• Advanced osteoarthritis of the shoulder
• History of fracture or dislocation affecting the shoulder region
• Advanced acromioclavicular joint pathology
• Massive rotator cuff tear (positive lag signs)
• Previous shoulder surgery
• Presence of neurological disorders
• Diagnosis of rheumatoid arthritis
• History of cancer
• Symptomatic cervical spine pathology
• Corticosteroid injection to the shoulder within the past 6 weeks
• Cognitive impairments that may interfere with the ability to perform clinical tasks or execute attention shift-based exercises

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Attention Shift-Based Rehabilitation Group; Participants in this group will receive a supervised shoulder rehabilitation program combined with motor tasks targeting regions outside the shoulder. These additional tasks are designed to shift attention away from the painful shoulder region. Exercises will be performed twice per week for 6 weeks, with each session lasting approximately 60-75 minutes. All participants will also receive standardized patient education.	Other: Patient Education; Participants will receive patient education on basic muscle biomechanics, causes of rotator cuff-related shoulder pain, pain management strategies, activity modification, and proper sleeping positions.; Other: Attention Shift-Based Exercise Therapy; Participants will be enrolled in a structured, supervised shoulder rehabilitation program consisting of exercises recommended in the literature. The program will include a three-phase protocol comprising range of motion exercises, stretching exercises, and strengthening exercises. In addition to the standard shoulder exercise program, participants will perform concurrent motor tasks targeting regions outside the shoulder. These tasks are designed to shift attention away from the painful shoulder region by engaging other body segments (e.g., lower limb or contralateral limb movements performed simultaneously with shoulder exercises). The intervention will be delivered under the supervision of a physiotherapist twice per week over a 6-week period.
Active Comparator: Standard Exercise Group; Participants in this group will receive a standardized shoulder rehabilitation program consisting of conventional therapeutic exercises. No attention-shifting or additional motor tasks will be included. The program will be administered twice per week for 6 weeks, with each session lasting approximately 60-75 minutes. All participants will also receive standardized patient education.	Other: Patient Education; Participants will receive patient education on basic muscle biomechanics, causes of rotator cuff-related shoulder pain, pain management strategies, activity modification, and proper sleeping positions.; Other: Standard Exercise Therapy; Participants will be enrolled in a structured, supervised standard shoulder rehabilitation program consisting of exercises recommended in the literature. The program will include a three-phase protocol comprising range of motion exercises, stretching exercises, and strengthening exercises. The intervention will focus exclusively on the affected shoulder and will not include any additional cognitive or motor dual-task components or attention-shifting strategies. All exercises will be performed under the supervision of a physiotherapist twice per week over a 6-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale (NPRS)	NPRS will be used to evaluate pain levels. The scale consists of a numeric rating system ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will be asked to rate the intensity of their shoulder pain.	At baseline, at week 6, and at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing Scale (PCS)	PCS is a self-reported questionnaire used to assess cognitive processes related to pain. It consists of 13 items, each rated on a 5-point Likert scale. Total scores range from 0 to 52. Higher scores indicate greater levels of pain catastrophizing.	At baseline, at week 6, and at week 12
The Western Ontario Rotator Cuff Index (WORC)	The Western Ontario Rotator Cuff Index (WORC) is a condition-specific, self-reported questionnaire designed to assess health-related quality of life (QoL) in individuals with rotator cuff disorders (Kirkley et al., 2003). It comprises 21 items presented on visual analogue scales (VAS), which are organized into five domains: physical symptoms, sports and recreation, work, lifestyle, and emotions. Each item is scored from 0 to 100 based on the respondent's selection along the visual analogue scale. The scores of all 21 items are summed to yield a total score ranging from 0 to 2100, with higher scores indicating greater disability and worse shoulder-related outcomes.	At baseline, at week 6, and at week 12.

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Shoulder pain; Rotator cuff; attention shift
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Arthralgia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Shoulder Pain; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Health Education; Patient Education as Topic
• Other Study ID Numbers: 03032001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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