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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Shift-Based Rehabilitation Group | Experimental | 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. |
|
| Standard Exercise Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Education | Other | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rezzan Atay, Bachelor's degree | Contact | 90+ 505 485 75 49 | rezzan.atay@ogr.iuc.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University-Cerrahpasa | Recruiting | Istanbul | Turkey (Türkiye) |
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Participants will be randomly assigned to one of two parallel groups: an attention shift-based rehabilitation group or a standard rehabilitation group. Both groups will receive supervised exercise interventions over a 6-week period, and outcomes will be compared between groups
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Participants will be blinded to group allocation.
| Attention Shift-Based Exercise Therapy | Other | 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. |
|
| Standard Exercise Therapy | Other | 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. |
|
| At baseline, at week 6, and at week 12. |
| 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 |
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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