Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-19 @ 9:20 AM
Study NCT ID:
NCT02478567
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2015-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Training Sequence for Subacromial Impingement Syndrome
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-14', 'studyFirstSubmitDate': '2015-06-16', 'studyFirstSubmitQcDate': '2015-06-17', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "American Shoulder Elbow Surgeon's Outcome Score", 'timeFrame': '16 weeks', 'description': 'self-report of function'}, {'measure': 'Numeric Pain Score', 'timeFrame': '16 weeks', 'description': 'pain levels'}, {'measure': 'Global Rating of Change', 'timeFrame': '16 weeks', 'description': 'patient satisfaction'}, {'measure': 'Global Percentage of Improvement', 'timeFrame': '16 weeks', 'description': 'patient perception of status'}]}, 'conditionsModule': {'conditions': ['Subacromial Impingement Syndrome']}, 'descriptionModule': {'briefSummary': 'Randomized crossover trial evaluating the impact of exercise training sequence of axioscapular and rotator cuff exercises in patients diagnosed with subacromial impingement syndrome.', 'detailedDescription': 'While physical therapy is an effective element in the rehabilitation of rotator cuff (RC) disease, the most effective sequence of training interventions has not been defined. The purpose of this study is to determine if there is a difference in pain or function in patients who are given RC strengthening prior to or after initiating scapular stabilization exercises.\n\nThe study was a prospective randomized crossover design. 26 men and 14 women, mean age 51, diagnosed with subacromial impingement syndrome (SAIS) were randomly assigned to one of two groups for a comprehensive and standardized rehabilitation program over six visits at an orthopedic outpatient clinic. One group was prescribed a 4-week program of scapular stabilization exercises while the other group began with RC strengthening exercises. The crossover design had each group add the previously excluded four exercises to their second month of rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years of age\n* diagnosis of Neer Stage I/II subacromial impingement with a primary pain complaint in the shoulder and/or upper arm\n* presence of at least two of the following findings: painful arc, weakness in external rotation, positive impingement sign (Hawkins-Kennedy or Neer/Walsh tests), pain and/or weakness with resistance to internal rotation, external rotation, or scapular plane elevation.\n\nExclusion Criteria:\n\n* concurrent medical co-morbidities including pregnancy, diabetes, and rheumatoid arthritis -\n* osteoarthritis greater than grade 2 on the Kellgren-Lawrence scale\n* current diagnosis and/or previous history of glenohumeral instability or dislocation\n* full-thickness rotator cuff tear\n* adhesive capsulitis\n* fractures of the scapula, clavicle or humerus\n* scapulothoracic or rotator cuff paresis\n* shoulder surgery in past year\n* inability to speak the English language at a level sufficient to obtain informed consent.'}, 'identificationModule': {'nctId': 'NCT02478567', 'briefTitle': 'Exercise Training Sequence for Subacromial Impingement Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'The Effect of Axioscapular and Rotator Cuff Exercise Training Sequence in Patients With Subacromial Impingement Syndrome: A Randomized Crossover Trial', 'orgStudyIdInfo': {'id': '052012-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scapular Training', 'description': 'Initiated scapular training exercise for the first 4 weeks followed by addition of rotator cuff exercises the next four weeks', 'interventionNames': ['Other: Scapular Training']}, {'type': 'EXPERIMENTAL', 'label': 'Rotator Cuff Training', 'description': 'initiated rotator cuff training exercise for the first 4 weeks followed by addition of scapular training exercises the next four weeks.', 'interventionNames': ['Other: Rotator Cuff Training']}], 'interventions': [{'name': 'Rotator Cuff Training', 'type': 'OTHER', 'otherNames': ['exercise'], 'description': 'four specific band-resisted strength training exercises for scapula', 'armGroupLabels': ['Rotator Cuff Training']}, {'name': 'Scapular Training', 'type': 'OTHER', 'otherNames': ['exercise'], 'description': 'four specific band-resisted strength training exercises for rotator cuff', 'armGroupLabels': ['Scapular Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76039', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ed Mulligan', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}