Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
Study NCT ID:
NCT07277868
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-11-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Scapular Stabilization Exercises on Pain and Functional Outcomes in Subacromial Impingement Syndrome: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The study uses single-blind masking. Only outcome assessors and statisticians are blinded to group assignments. Participants and treating physiotherapists are not blinded due to the nature of the intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study uses a parallel assignment model in which participants are allocated into two distinct groups: (1) standard physiotherapy and (2) standard physiotherapy plus scapular stabilization-mobilization-based rehabilitation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-30', 'studyFirstSubmitDate': '2025-11-27', 'studyFirstSubmitQcDate': '2025-11-30', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score', 'timeFrame': 'Baseline, Week 6, Week 12', 'description': 'QuickDASH is an 11-item validated questionnaire that measures physical function and symptoms related to upper extremity disorders. Total scores range from 0 to 100, with higher scores indicating greater disability. The primary outcome is the change in QuickDASH score from baseline to Week 12.'}], 'secondaryOutcomes': [{'measure': 'Modified Constant-Murley Score (CMS)', 'timeFrame': 'Baseline, Week 6, Week 12', 'description': 'The Constant-Murley Score assesses shoulder pain (15 points), daily activities (20 points), range of motion (40 points), and strength (25 points). Total score ranges from 0 to 100, with higher scores indicating better function. The secondary outcome is the improvement in CMS over time.'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, Week 6, Week 12', 'description': 'Pain intensity at rest is measured using a 10-cm Visual Analog Scale (0 = no pain, 10 = worst pain). The outcome represents the change in resting pain levels over time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise Therapy', 'Shoulder Rehabilitation', 'Scapular Stabilization', 'Functional Outcomes'], 'conditions': ['Subacromial Impingement Syndrome']}, 'descriptionModule': {'briefSummary': 'This randomized controlled study aims to evaluate the effects of scapular stabilization exercises on pain, shoulder function, and quality of life in patients with subacromial impingement syndrome. Participants will be randomly assigned to either a scapular stabilization exercise program or a conventional shoulder rehabilitation program. Pain, functional outcome measures, and patient-reported quality of life will be assessed at baseline, 4 weeks, and 12 weeks. The study seeks to determine whether adding scapular stabilization exercises provides superior clinical benefit.', 'detailedDescription': 'Subacromial impingement syndrome (SIS) is one of the most common causes of shoulder pain and functional limitation. Scapular dyskinesis plays a key role in the development and persistence of SIS by altering scapulohumeral rhythm and increasing mechanical stress on subacromial tissues. Scapular stabilization exercises are increasingly used to restore normal scapular mechanics, improve muscular control, and reduce pain, but the clinical effectiveness of these exercises compared to conventional rehabilitation programs remains unclear.\n\nThis prospective, single-blind randomized controlled study investigates the effects of a scapular stabilization exercise program on pain, functional outcomes, and quality of life in patients diagnosed with SIS. Participants are randomly allocated to either a scapular stabilization group or a conventional shoulder rehabilitation group. Pain (VAS), functional status (QuickDASH and SPADI), range of motion, and quality-of-life measures are assessed at baseline, 4 weeks, and 12 weeks. The study aims to determine whether adding scapular stabilization exercises to standard rehabilitation leads to superior clinical improvement compared to conventional therapy alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 65 years.\n* Clinically diagnosed subacromial impingement syndrome (SIS) based on:positive Neer test ,positive Hawkins-Kennedy test ,painful arc between 60°-120°,pain during resisted shoulder tests\n* Symptoms present for at least 4 weeks.\n* Ability to comply with a 12-week supervised rehabilitation program.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Previous shoulder surgery on the affected side.\n* Presence of full-thickness rotator cuff tear confirmed by ultrasound imaging.\n* Evidence of cervical radiculopathy or significant cervical spine pathology.\n* Advanced glenohumeral or acromioclavicular osteoarthritis.\n* History of inflammatory rheumatic diseases (e.g., rheumatoid arthritis, ankylosing spondylitis).\n* Severe cardiopulmonary, neurological, or systemic conditions limiting physical activity.\n* Recent shoulder fracture or dislocation (\\< 6 months).\n* Participation in another structured shoulder rehabilitation program within the last 3 months.\n* Pregnancy.\n* Inability to understand or follow instructions required for the intervention or assessments.'}, 'identificationModule': {'nctId': 'NCT07277868', 'briefTitle': 'Effect of Scapular Stabilization Exercises on Pain and Functional Outcomes in Subacromial Impingement Syndrome: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Effect of Scapular Stabilization Exercises on Functional Outcomes in the Treatment of Subacromial Impingement Syndrome: A Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'impingement-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Physiotherapy', 'description': 'Participants in this arm receive standard physiotherapy consisting of electrotherapy, range-of-motion exercises, and stretching. The program is administered three times per week for 12 weeks. No scapular-specific stabilization or mobilization exercises are included. All participants also receive a home exercise program for daily stretching and mobility exercises.', 'interventionNames': ['Other: Standard Physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Scapular Stabilization + Mobilization-Based Rehabilitation', 'description': 'Participants receive the same standard physiotherapy as the control group, combined with a supervised scapular stabilization and mobilization-based rehabilitation program. This structured 12-week protocol (3 sessions per week) includes passive scapular mobilization (10-12 minutes per session) and a three-phase stabilization exercise progression targeting scapular mechanics, muscle activation, strength, and neuromuscular control. A daily home exercise program is also provided.', 'interventionNames': ['Other: Standard Physiotherapy']}], 'interventions': [{'name': 'Standard Physiotherapy', 'type': 'OTHER', 'otherNames': ['Conventional Physiotherapy, Routine Physiotherapy'], 'description': 'Standard physiotherapy consisting of electrotherapy modalities, range-of-motion exercises, and stretching exercises. The program is administered three times per week for 12 weeks. The intervention does not include any scapular-specific stabilization or mobilization techniques. All participants receive a home exercise program including daily stretching and mobility exercises.', 'armGroupLabels': ['Scapular Stabilization + Mobilization-Based Rehabilitation', 'Standard Physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34303', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Zeynep Karakuzu Güngör', 'role': 'CONTACT', 'email': 'zeynepkarakuzu@hotmail.com.tr', 'phone': '+905077750375'}], 'facility': 'Kanuni Sultan Süleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Zeynep Karakuzu Güngör', 'role': 'CONTACT', 'email': 'zeynepkarakuzu@hotmail.com.tr', 'phone': '+905077750375'}], 'overallOfficials': [{'name': 'Zeynep Karakuzu Güngör', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kanuni Sultan Süleyman Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because data sharing is not planned for this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist in Physical Medicine and Rehabilitation', 'investigatorFullName': 'Zeynep Karakuzu Güngör', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}