Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-21 @ 12:19 AM
Study NCT ID:
NCT04956757
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2021-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scapula Retraction Exercises in Subacromial Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018771', 'term': 'Arthralgia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-10', 'studyFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2021-07-08', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acromiohumeral Distance (AHD) measurement', 'timeFrame': 'Acromiohumeral distance values will be recorded at baseline and 8-week follow-up', 'description': 'Acromiohumeral Distance will be recorded at 0°, 30°, 45°, 60° and 90° of shoulder abduction, and while they are doing scapular retraction with resistive elastic band at each shoulder position. All assessment will be recorded at baseline and at the end of the eight week rehabilitation sessions'}], 'secondaryOutcomes': [{'measure': 'pain severity', 'timeFrame': 'pain severity will be recorded at baseline and 8-week follow-up', 'description': 'pain severity will be assessed by using 100 millimeters Visual Analogue Scale at rest, at night and during activity.\n\nAll patients were asked to mark their pain level that corresponds to their pain intensity on the line between "0=no pain" and "100=the worst pain imaginable".'}, {'measure': 'disability status', 'timeFrame': 'PADI Score will be recorded at baseline and 8-week follow-up', 'description': 'disability status will be assessed by using Shoulder Pain and Disability Index (SPADİ). All assessment will be recorded at baseline and at the end of the eight week treatment sessions.\n\nThe questionnaire is scored on a 100-point scale, where 0 represents "no disabilities" and 100 represents "extreme disabilities"'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain severity', 'functional status', 'acromiohumeral distance', 'shoulder pain'], 'conditions': ['Rotator Cuff Impingement Syndrome']}, 'descriptionModule': {'briefSummary': 'Scapula retraction exercises are often recommended as a part of the exercise programs. The primary aim of this study is to investigate the initial effect of the scapula retraction exercises on acromiohumeral distance (AHD) at varying shoulder abduction angles and to compare asymptomatic subjects. The secondary aim of this study is to investigate the effect of scapula retraction exercises on AHD values and symptoms (pain and disability) in patients with SPS.', 'detailedDescription': 'Subacmial pain syndrome (SPS) is a common cause of shoulder pain and dysfunction in the general population. Exercise interventions is thought as a primary choice in clinical settings. Scapula retraction exercises are commonly recommended as a part of the exercise programs. Applying scapula retraction exercises at varying shoulder abduction angles could restore balance between the scapulothoracic muscles. Since the scapulothoracic muscles dynamically control subacromial space, scapula retraction exercises could further help to maintain AHD during arm elevation.\n\nThe primary aim of this study is to investigate the initial effect of the scapula retraction exercises on acromiohumeral distance (AHD) at varying shoulder abduction angles and to compare asymptomatic subjects. The secondary aim of this study is to investigate the effect of scapula retraction exercises on AHD values and symptoms (pain and disability) in patients with SPS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria:\n\n* aged between 18-45\n* painful arc of movement during flexion or abduction;\n* positive Neer or Kennedy-Hawkins impingement signs\n* pain on resisted lateral rotation, abduction or empty can test.\n\nExclusion Criteria:\n\n* previous shoulder surgery;\n* shoulder pain reproduced by neck movement;\n* clinical signs of full-thickness RC tears; or\n* adhesive capsulitis.'}, 'identificationModule': {'nctId': 'NCT04956757', 'briefTitle': 'Scapula Retraction Exercises in Subacromial Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigating the Effect of Scapula Retraction Exercises on Acromiohumeral Distance Values and Symptoms (Pain and Disability) in Patients With SPS', 'orgStudyIdInfo': {'id': 'GO18/55'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'exercise program consists of progressive scapula retraction exercises will be applied three times a week total 24 sessions.\n\nHome exercise program will also advised two times a day.', 'interventionNames': ['Other: Exercise Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control group will not perform scapula retraction exercises. AHD values of the control group will be compared to intervention groups both retracted and non-retracted conditions.'}], 'interventions': [{'name': 'Exercise Intervention', 'type': 'OTHER', 'description': 'Scapula retraction exercises at varying shoulder abduction angles will be applied', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Leyla Eraslan', 'investigatorAffiliation': 'Hacettepe University'}}}}