Rotator Cuff Related Shoulder Pain, Rotator Cuff Tears of the Shoulder, Shoulder Bursitis, Shoulder Tendinopathy, Subacromial Pain Syndrome
Conditions
Keywords
Rotator cuff, Shoulder pain, attention shift
Brief summary
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
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.
Interventions
OTHERPatient 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.
OTHERAttention 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.
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.
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to group allocation.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | At baseline, at week 6, and at week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Western Ontario Rotator Cuff Index (WORC) | At baseline, at week 6, and at week 12. | 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. |
| Pain Catastrophizing Scale (PCS) | At baseline, at week 6, and at week 12 | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTRezzan Atay, Bachelor's degree
Outcome results
None listed