Rotator Cuff Related Shoulder PainNCT07546084
The Effect of an Exercise Program Based on Attentional Focus Shifting on Clinical Outcomes in Rotator Cuff Related Shoulder Pain
A study testing Patient Education, Attention Shift-Based Exercise Therapy and Standard Exercise Therapy in people with Rotator Cuff Related Shoulder Pain and Subacromial Pain Syndrome, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Related Shoulder Pain, Subacromial Pain Syndrome, Shoulder Bursitis
- What is being tested?
- Patient Education, Attention Shift-Based Exercise Therapy and Standard Exercise Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa
Istanbul
About this study
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:
Read more
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
Read the 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.
- Conditions
- Rotator Cuff Related Shoulder Pain, Subacromial Pain Syndrome, Shoulder Bursitis, Shoulder Tendinopathy, Rotator Cuff Tears of the Shoulder
- Being tested
- Patient Education, Attention Shift-Based Exercise Therapy, Standard Exercise Therapy
- Keywords
- Rotator cuff, Shoulder pain, attention shift
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient EducationOther
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.
Attention Shift-Based Exercise TherapyOther
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 TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient Education; Other: Attention Shift-Based Exercise Therapy |
| 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. Receives: Other: Patient Education; Other: Standard Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, at week 6, and at week 12
Secondary outcomes (2)
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.
Measured: 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.
Measured: At baseline, at week 6, and at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Related Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Celik, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546084
- Sponsor's protocol ID
- 03032001
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Exercise Program Based on Attentional Focus Shifting on Clinical Outcomes in Rotator Cuff Related Shoulder Pain
- ClinicalTrials.gov ID
- NCT07546084
- Acronym / sponsor ID
- 03032001
- Conditions
- Rotator Cuff Related Shoulder Pain, Subacromial Pain Syndrome, Shoulder Bursitis, Shoulder Tendinopathy, Rotator Cuff Tears of the Shoulder
- Keywords
- Rotator cuff, Shoulder pain, attention shift
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Attention Shift-Based Rehabilitation Group | Experimental | Other: Patient Education, Other: Attention Shift-Based Exercise TherapyParticipants 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 | Other: Patient Education, Other: Standard Exercise TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient EducationParticipants 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 Rehabilitation Group, Standard Exercise Group |
| Attention Shift-Based Exercise TherapyParticipants 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. | Other | Attention Shift-Based Rehabilitation Group |
| Standard Exercise TherapyParticipants 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. | Other | Standard Exercise Group |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 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.
2 secondary outcomes
The Western Ontario Rotator Cuff Index (WORC)
Time frame: At baseline, at week 6, and at week 12.
Pain Catastrophizing Scale (PCS)
Time frame: At baseline, at week 6, and at week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education, Attention Shift-Based Exercise Therapy and Standard Exercise Therapy in people with Rotator Cuff Related Shoulder Pain and Subacromial Pain Syndrome, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rezzan Atay, Bachelor's degree (90+ 505 485 75 49, rezzan.atay@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: At baseline, at week 6, and at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.