Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:47 PM
Study NCT ID:
NCT07415967
Status:
RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Dual-Task Technique-Based Exercise Program on Clinical Outcomes in Rotator Cuff Related Shoulder Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010353', 'term': 'Patient Education as Topic'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-06-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain Rating Scale (NPRS)', 'timeFrame': 'At baseline, at week 6, and at week 12', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)', 'timeFrame': 'At baseline, at week 6, and at week 12', 'description': '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.'}, {'measure': 'The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)', 'timeFrame': 'At baseline, at week 6, and at week 12', 'description': '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.'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'At baseline, at week 6, and at week 12', 'description': '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.'}, {'measure': 'Tampa Scale of Kinesiophobia-11 (TSK-11)', 'timeFrame': 'At baseline, at week 6, and at week 12', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rotator cuff', 'Shoulder pain', 'Dual-task exercise'], 'conditions': ['Rotator Cuff Related Shoulder Pain', 'Shoulder Pain Syndrome', 'Subacromial Pain Syndrome']}, 'descriptionModule': {'briefSummary': '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:\n\n* 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?\n* Is there a difference between these two exercise approaches in terms of shoulder function and psychosocial factors?\n\nParticipants will:\n\n* Participate in either a dual-task-based shoulder exercise program or a standard shoulder exercise program twice per week for 6 weeks.\n* Undergo clinical assessments at baseline, at week 6, and at week 12.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 65 years\n* Diagnosis of impingement syndrome, subacromial bursitis, rotator cuff tendinopathy, or partial rotator cuff tear\n* Shoulder pain level ≥3 according to the Numeric Pain Rating Scale (NPRS)\n* Shoulder pain persisting for at least 3 months\n\nExclusion Criteria:\n\n* Diagnosis of shoulder instability, adhesive capsulitis, or full-thickness or massive rotator cuff tear\n* Presence of musculoskeletal, neurological, and/or psychological conditions that would prevent participation in an exercise program\n* History of shoulder surgery\n* Having received physiotherapy or corticosteroid injection treatment for shoulder pain within the past 6 months\n* Presence of cognitive impairment that would prevent participation in dual-task exercise activities'}, 'identificationModule': {'nctId': 'NCT07415967', 'briefTitle': 'The Effect of a Dual-Task Technique-Based Exercise Program on Clinical Outcomes in Rotator Cuff Related Shoulder Pain', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'The Effect of a Dual-Task Technique-Based Exercise Program on Clinical Outcomes in Rotator Cuff Related Shoulder Pain', 'orgStudyIdInfo': {'id': '2190016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dual-Task Technique-Based Exercise Group', 'description': '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.', 'interventionNames': ['Other: Patient Education', 'Other: Dual-Task-Based Exercise Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Exercise Group', 'description': '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.', 'interventionNames': ['Other: Patient Education', 'Other: Standard Exercise Therapy']}], 'interventions': [{'name': 'Patient Education', 'type': 'OTHER', 'description': 'Participants will receive patient education on basic muscle biomechanics, causes of pain, pain management strategies, and proper sleeping positions.', 'armGroupLabels': ['Dual-Task Technique-Based Exercise Group', 'Standard Exercise Group']}, {'name': 'Dual-Task-Based Exercise Therapy', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Dual-Task Technique-Based Exercise Group']}, {'name': 'Standard Exercise Therapy', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Standard Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': "İrem Ece İçöz, Bachelor's degree", 'role': 'CONTACT', 'email': 'iremece.icoz@ogr.iuc.edu.tr', 'phone': '90+ 5511040686'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Derya Celik', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}