Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
Study NCT ID:
NCT03494192
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2018-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Exercise Trainings on Pain, Function and AHD in Patients With SPS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D010146', 'term': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2018-04-09', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'pain assessment', 'timeFrame': 'from baseline to 6-month follow up', 'description': 'pain intensity will de assessed by using Visual Analog Scale at rest, activity and at night. All assessment will be recorded at baseline, at the end of the 12-week treatment sessions and 6-month follow-up.'}, {'measure': 'Acromiohumeral Distance Measurement', 'timeFrame': 'from baseline to 6-month follow up', 'description': 'Acromiohumeral Distance will be measured by 0°, 30°, 45°, 60° and 90° of shoulder abduction positions. All assessment will be recorded at baseline, at the end of the 12-week treatment sessions and 6-month follow-up.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'at 12 week and 6-month follow ups', 'description': 'Patient Satisfaction will be assessed by simple questions consisting of self- recovery rate and patients expectation'}], 'primaryOutcomes': [{'measure': 'Functional Level', 'timeFrame': 'ffrom baseline to twelve week after treatment sessions', 'description': 'Functional level will be assessed by using Shoulder Pain and Disability Index (SPADİ). All assessment will be recorded at baseline, at the end of the 12-week treatment sessions and 6-month follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acromiohumeral distance', 'pain', 'functional level', 'Subacromial Impingement Syndrome'], 'conditions': ['Subacromial Impingement Syndrome']}, 'descriptionModule': {'briefSummary': 'Abnormal reduction of the AHD has been considered as one of the possible mechanisms in the aetiology of subacromial pain syndrome. Maintenance of the AHD is crucial for prevention and rehabilitation of rotator cuff related disorders.\n\nThe development of a rehabilitation treatment plan is based in part on the assessment of scapular motion and muscle deficits in patients with shoulder pain. Rehabilitation should be based on the identified impairments.\n\nThe aim of this study is to investigate the effect of utilizing scapula retraction exercises with or without glenohumeral rotational exercises at gradual shoulder elevation angles into a scapular stabilization program on functionality, pain and AHD in patients with SPS and compare with health population.', 'detailedDescription': 'Coordinated motion between the humerus and scapula is required for pain-free arm movement. Rotator cuff and scapulothoracic muscles dynamically control the subacromial space or acromiohumeral distance (AHD).Scapulothoracic muscles need to provide stability and control in a synchronized fashion to facilitate normal scapulohumeral movement. Scapular upward rotation and posterior tilt is essential to maintain the AHD.Therefore, the force couple function of the rotator cuff muscles play an critical role in opposing the superior migration force that is generated by deltoid muscle and, to maintenance the subacromial space.\n\nAbnormal reduction of the AHD has been considered as one of the possible mechanisms in the aetiology of subacromial impingement syndrome. Maintenance of the AHD is crucial for prevention and rehabilitation of rotator cuff related disorders.\n\nThe development of a rehabilitation treatment plan is based in part on the assessment of scapular motion and muscle deficits in patients with shoulder pain. Rehabilitation should be based on the identified impairments.\n\nhe aim of this study is to investigate the effect of utilizing scapula retraction exercises with or without glenohumeral rotational exercises at gradual shoulder elevation angles into a scapular stabilization program on functionality, pain and AHD in patients with SPS and compare with health population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\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* shoulder capsulitis.'}, 'identificationModule': {'nctId': 'NCT03494192', 'briefTitle': 'Effects of Exercise Trainings on Pain, Function and AHD in Patients With SPS', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Utilizing Scapula Retraction Exercises With or Without Glenohumeral Rotational Exercises With a Gradual Progression: A Double-Blind Randomized Controlled Trial for Subacromial Pain Syndrome', 'orgStudyIdInfo': {'id': 'KA-180018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'scapula retraction exercise group', 'description': '* Manual Therapy\n* Stretching Exercises\n* Exercise training focus on scapulothoracic muscles will be applied two times per week total 12 week After 12 week follow-up, patients will proceed to reduced exercise program until the 6-month follow-up.', 'interventionNames': ['Other: Scapula Retraction Exercise Group']}, {'type': 'EXPERIMENTAL', 'label': 'Scapula Retraction +Glenohumeral Rotational Exercise Group', 'description': '* Manual Therapy\n* Stretching Exercises\n* Exercise training focus on scapulothoracic muscles\n* Exercise training focus on rotator cuff muscles will be applied two times per week total 12 week After 12 week follow-up, patients will proceed to reduced exercise program until the 6-month follow-up.', 'interventionNames': ['Other: Scapula Retraction +Glenohumeral Rotational Exercise Group']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Age-sex and hand-dominancy matched healthy controls will be included as a control group (CG) for acromiohumeral distance (AHD) normative data'}], 'interventions': [{'name': 'Scapula Retraction Exercise Group', 'type': 'OTHER', 'otherNames': ['scapula stabilization exercises'], 'description': 'physiotherapy program consists of manual therapy, supervised stretching and scapulothoracic muscles strengthening exercises and home exercise programme including stretching and strengthening exercises will be applied two times a week total 24 sessions.\n\nAfter 24 sessions completed, patients will proceed to reduced exercise program until the 6-month follow-up.', 'armGroupLabels': ['scapula retraction exercise group']}, {'name': 'Scapula Retraction +Glenohumeral Rotational Exercise Group', 'type': 'OTHER', 'otherNames': ['Scapula stabilization +Glenohumeral Rotational Exercise Group'], 'description': 'physiotherapy program consists of manual therapy, supervised stretching and scapulothoracic and also rotator cuff muscles strengthening exercises and home exercise programme including stretching and strengthening exercises will be applied two times a week total 24 sessions.\n\nAfter 24 sessions completed, patients will proceed to reduced exercise program until the 6-month follow-up', 'armGroupLabels': ['Scapula Retraction +Glenohumeral Rotational Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University, Faculty of Health Sciences, Dept. of Physiotherapy and Rehabilitation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We will share IPD when we recruiting the patients'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Leyla Eraslan', 'investigatorAffiliation': 'Hacettepe University'}}}}