Rotator Cuff Related Shoulder PainNCT07415967
The Effect of a Dual-Task Technique-Based Exercise Program on Clinical Outcomes in Rotator Cuff Related Shoulder Pain
A study testing Patient Education, Dual-Task-Based Exercise Therapy and Standard Exercise Therapy in people with Rotator Cuff Related Shoulder Pain and Shoulder 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 a dual-task-based exercise program on clinical outcomes in individuals with rotator cuff-related shoulder pain. The study will evaluate the effects of a dual-task exercise approach, in which physical exercises are performed concurrently with cognitive… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Related Shoulder Pain, Shoulder Pain Syndrome, Subacromial Pain Syndrome
- What is being tested?
- Patient Education, Dual-Task-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
- 16 Feb 2026to 16 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
- Aged between 18 and 65 years
- Diagnosis of impingement syndrome, subacromial bursitis, rotator cuff tendinopathy, or partial rotator cuff tear
- Shoulder pain level ≥3 according to the Numeric Pain Rating Scale (NPRS)
- Shoulder pain persisting for at least 3 months
Who cannot join
- Diagnosis of shoulder instability, adhesive capsulitis, or full-thickness or massive rotator cuff tear
- Presence of musculoskeletal, neurological, and/or psychological conditions that would prevent participation in an exercise program
- History of shoulder surgery
- Having received physiotherapy or corticosteroid injection treatment for shoulder pain within the past 6 months
- Presence of cognitive impairment that would prevent participation in dual-task exercise activities
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 a dual-task-based exercise program on clinical outcomes in individuals with rotator cuff-related shoulder pain. The study will evaluate the effects of a dual-task exercise approach, in which physical exercises are performed concurrently with cognitive tasks, on pain, functional status, pain catastrophizing and kinesiophobia. 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 rotator cuff-related shoulder pain who participate in a dual-task-based exercise program and those who participate in a standard exercise program?
- Is there a difference between these two exercise approaches in terms of shoulder function and psychosocial factors?
Read more
Participants will:
- Participate in either a dual-task-based shoulder exercise program or a standard shoulder exercise program twice per week for 6 weeks.
- Undergo clinical assessments at baseline, at week 6, and at week 12.
Read the detailed description
A total of 46 patients will be included in the study based on the results of a power analysis. Participants will be randomly allocated into two groups using a computer-based randomization program: the Dual-Task Technique-Based Exercise Group (Group 1) and the Standard Exercise Group (Group 2). Both groups will receive patient education and participate in a supervised exercise program. In the Dual-Task Technique-Based Exercise Group, exercise sessions will be performed concurrently with cognitive tasks. The Standard Exercise Group will undergo a standard shoulder exercise program without cognitive task integration. The intervention will be administered twice per week for a total of 12 sessions over a 6-week period. Clinical assessments will be conducted for both groups at baseline (before treatment), at the end of the intervention (week 6), and at week 12 as a follow-up assessment. The primary outcome measure will be pain intensity, assessed using the Numeric Pain Rating Scale (NPRS). Secondary outcome measures will include the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (Q-DASH), the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), the Pain Catastrophizing Scale (PCS) and the Tampa Scale of Kinesiophobia-11 (TSK-11).
- Being tested
- Patient Education, Dual-Task-Based Exercise Therapy, Standard Exercise Therapy
- Keywords
- Rotator cuff, Shoulder pain, Dual-task exercise
- 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 pain, pain management strategies, and proper sleeping positions.
Dual-Task-Based Exercise TherapyOther
Participants will be enrolled in a structured exercise program consisting of exercises recommended in the literature. The program will include a three-phase exercise protocol comprising range of motion exercises, stretching exercises, and strengthening exercises. In addition to the standard shoulder exercise program, participants will perform concurrent cognitive tasks targeting attention, cognitive processing, working memory, and verbal fluency. The exercise program 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 exercise program consisting of exercises recommended in the literature. The program will include a three-phase exercise protocol comprising range of motion exercises, stretching exercises, and strengthening exercises. The exercise program will be delivered under the supervision of a physiotherapist twice per week over a 6-week period.
| Study group | Role | What they receive |
|---|---|---|
| Dual-Task Technique-Based Exercise Group | Experimental | Patients will receive a treatment program consisting of patient education and exercise therapy twice per week for a total of 12 sessions. Exercise sessions will be performed concurrently with cognitive tasks. Receives: Other: Patient Education; Other: Dual-Task-Based Exercise Therapy |
| Standard Exercise Group | Active comparator | Patients will receive a treatment program consisting of patient education and exercise therapy twice per week for a total of 12 sessions, following a standard shoulder exercise approach. 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 (4)
Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)
QuickDASH is an 11-item self-reported questionnaire used to assess the ability to perform specific upper extremity activities. Participants rate each item on a 5-point Likert scale. Total scores range from 0 to 100, with higher scores indicating greater functional disability.
Measured: At baseline, at week 6, and at week 12
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
ASES is a questionnaire consisting of a patient-reported pain component assessed using a visual analog scale and a functional component including 10 items related to activities of daily living. The total score ranges from 0 to 100. Higher scores indicate better functional ability.
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
Tampa Scale of Kinesiophobia-11 (TSK-11)
TSK-11 is the most commonly used shortened version of the Tampa Scale of Kinesiophobia and is used to assess fear of movement or re-injury. It consists of 11 items, each rated on a 4-point Likert scale. Total scores range from 11 to 44. Higher scores indicate greater fear of movement.
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 posted17 Feb 2026
- Study start16 Feb 2026
- Primary completion16 Feb 2027 (estimated)
- Study completion16 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
- 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 - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415967
- Sponsor's protocol ID
- 2190016
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2026
- Last updated
- 20 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Dual-Task Technique-Based Exercise Program on Clinical Outcomes in Rotator Cuff Related Shoulder Pain
- ClinicalTrials.gov ID
- NCT07415967
- Acronym / sponsor ID
- 2190016
- Keywords
- Rotator cuff, Shoulder pain, Dual-task exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 16 Feb 2027 (estimated)
- Study completion
- 16 Jun 2027 (estimated)
- First posted
- 17 Feb 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 a dual-task-based exercise program on clinical outcomes in individuals with rotator cuff-related shoulder pain. The study will evaluate the effects of a dual-task exercise approach, in which physical exercises are performed concurrently with cognitive tasks, on pain, functional status, pain catastrophizing and kinesiophobia. 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 rotator cuff-related shoulder pain who participate in a dual-task-based exercise program and those who participate in a standard exercise program?
- Is there a difference between these two exercise approaches in terms of shoulder function and psychosocial factors?
Participants will:
- Participate in either a dual-task-based shoulder exercise program or a standard shoulder exercise program twice per week for 6 weeks.
- Undergo clinical assessments at baseline, at week 6, and at week 12.
Detailed description
A total of 46 patients will be included in the study based on the results of a power analysis. Participants will be randomly allocated into two groups using a computer-based randomization program: the Dual-Task Technique-Based Exercise Group (Group 1) and the Standard Exercise Group (Group 2). Both groups will receive patient education and participate in a supervised exercise program. In the Dual-Task Technique-Based Exercise Group, exercise sessions will be performed concurrently with cognitive tasks. The Standard Exercise Group will undergo a standard shoulder exercise program without cognitive task integration. The intervention will be administered twice per week for a total of 12 sessions over a 6-week period. Clinical assessments will be conducted for both groups at baseline (before treatment), at the end of the intervention (week 6), and at week 12 as a follow-up assessment. The primary outcome measure will be pain intensity, assessed using the Numeric Pain Rating Scale (NPRS). Secondary outcome measures will include the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (Q-DASH), the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), the Pain Catastrophizing Scale (PCS) and the Tampa Scale of Kinesiophobia-11 (TSK-11).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-Task Technique-Based Exercise Group | Experimental | Other: Patient Education, Other: Dual-Task-Based Exercise TherapyPatients will receive a treatment program consisting of patient education and exercise therapy twice per week for a total of 12 sessions. Exercise sessions will be performed concurrently with cognitive tasks. |
| Standard Exercise Group | Active comparator | Other: Patient Education, Other: Standard Exercise TherapyPatients will receive a treatment program consisting of patient education and exercise therapy twice per week for a total of 12 sessions, following a standard shoulder exercise approach. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 65 years
- Diagnosis of impingement syndrome, subacromial bursitis, rotator cuff tendinopathy, or partial rotator cuff tear
- Shoulder pain level ≥3 according to the Numeric Pain Rating Scale (NPRS)
- Shoulder pain persisting for at least 3 months
Key exclusion criteria (5 listed)
- Diagnosis of shoulder instability, adhesive capsulitis, or full-thickness or massive rotator cuff tear
- Presence of musculoskeletal, neurological, and/or psychological conditions that would prevent participation in an exercise program
- History of shoulder surgery
- Having received physiotherapy or corticosteroid injection treatment for shoulder pain within the past 6 months
- Presence of cognitive impairment that would prevent participation in dual-task exercise activities
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 pain, pain management strategies, and proper sleeping positions. | Other | Dual-Task Technique-Based Exercise Group, Standard Exercise Group |
| Dual-Task-Based Exercise TherapyParticipants will be enrolled in a structured exercise program consisting of exercises recommended in the literature. The program will include a three-phase exercise protocol comprising range of motion exercises, stretching exercises, and strengthening exercises. In addition to the standard shoulder exercise program, participants will perform concurrent cognitive tasks targeting attention, cognitive processing, working memory, and verbal fluency. The exercise program will be delivered under the supervision of a physiotherapist twice per week over a 6-week period. | Other | Dual-Task Technique-Based Exercise Group |
| Standard Exercise TherapyParticipants will be enrolled in a structured exercise program consisting of exercises recommended in the literature. The program will include a three-phase exercise protocol comprising range of motion exercises, stretching exercises, and strengthening exercises. The exercise program will be delivered 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.
4 secondary outcomes
Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)
Time frame: At baseline, at week 6, and at week 12
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
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
Tampa Scale of Kinesiophobia-11 (TSK-11)
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 20 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, Dual-Task-Based Exercise Therapy and Standard Exercise Therapy in people with Rotator Cuff Related Shoulder Pain and Shoulder 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 4 inclusion and 5 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 20 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 İrem Ece İçöz, Bachelor's degree (90+ 5511040686, iremece.icoz@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 20 Apr 2026.