Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-04 @ 10:12 PM
Study NCT ID:
NCT03246867
Status:
COMPLETED
Last Update Posted:
2020-02-21
First Post:
2017-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Acute Effects of Different Stretching Methods in Individuals With 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': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'All of participants must have subacromial impingement syndrome with glenohumeral internal rotation deficit.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are 3 groups. First group will receive isolytic stretching in modified cross body position. Second group will receive static stretching in modified cross body position. The stretching exercise will be applied five times each for 15 seconds. After each stretching there will be a resting period for 5 seconds. Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Isolytic and static stretching groups will be evaluated before and just after stretching exercise. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-20', 'studyFirstSubmitDate': '2017-08-08', 'studyFirstSubmitQcDate': '2017-08-08', 'lastUpdatePostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder internal rotation range of motion', 'timeFrame': 'Baseline and just after stretching exercise', 'description': 'Change of shoulder internal rotation range of motion (with bubble inclinometer)'}], 'secondaryOutcomes': [{'measure': 'Posterior shoulder tightness', 'timeFrame': 'Baseline and just after stretching exercise', 'description': 'Change of posterior shoulder tightness (with bubble inclinometer)'}, {'measure': 'Concentric strength', 'timeFrame': 'Baseline and just after stretching exercise', 'description': 'Change of trapezius muscles, rotattor cuff muscles concentric strength (in kg, with hand held dynamometer)'}, {'measure': 'Eccentric strength', 'timeFrame': 'Baseline and just after stretching exercise', 'description': 'Change of shoulder abduction and external rotation eccentric strength (in kg, with hand held dynamometer)'}, {'measure': 'Subacromial space', 'timeFrame': 'Baseline and just after stretching exercise', 'description': 'Change of subacromial space ( with Ultrasound)'}, {'measure': 'Pain', 'timeFrame': 'Baseline and just after stretching exercise', 'description': 'Change of visual analog scale score in activity and rest'}, {'measure': 'Shoulder external rotation range of motion', 'timeFrame': 'Baseline and just after stretching exercise', 'description': 'Change of shoulder external rotation range of motion (with bubble inclinometer)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['isolytic stretching', 'static stretching', 'Glenohumeral Internal Rotation Deficit'], 'conditions': ['Subacromial Impingement Syndrome', 'Glenohumeral Internal Rotation Deficit']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate and compare the acute effects of isolytic and static stretching training in individuals having subacromial impingement syndrome with glenohumeral internal rotation deficit. Isolytic group will receive isolytic stretching in modified cross body position. Static group will receive static stretching in modified cross body position. Stretching groups will be evaluated before and just after stretching exercise. Control group will receive no stretching. Control group will be evaluated for the first time and then will be waited until the duration of the stretching exercise program. Afterwards, second evaluation will be performed', 'detailedDescription': 'There is no information in literature about the acute effects of isolytic stretching exercise in individuals having subacromial impingement syndrome with glenohumeral internal rotation deficit. The purpose of this study is to investigate and compare the acute effects of isolytic and static stretching training in individuals having subacromial impingement syndrome with glenohumeral internal rotation deficit.\n\nIn modified cross body position, static stretching group will perform active-assistive static stretching by the physiotherapist whereas isolytic stretching group will perform active-assistive isolytic stretching. Stretching exercises will be applied five times each for 15 seconds. After each stretching there will be a resting period for 5 seconds. Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Isolytic and static stretching groups will be evaluated before and just after stretching exercise. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of subacromial impingement syndrome\n* Glenohumeral internal rotation range of motion of the affected shoulder should be less than other shoulder and bilateral shoulder internal rotation range of motion difference should be ≥15 º\n* Pain with resisted arm elevation or external rotation as well as a minimum of 3 of 5 positive subacromial impingement syndrome tests, painful arc, pain or weakness with resisted external rotation, Neer, Hawkins and Jobe tests .\n* Ability to complete the entire study procedure\n\nExclusion Criteria:\n\n* An inability to elevate the involved arm greater than 140 degree in the scapular plane\n* A 50% limitation of passive shoulder range of motion in \\>2 planes of motion\n* Pain \\>7/10\n* A history of fracture to the shoulder girdle\n* Systemic musculoskeletal disease\n* History of shoulder surgery,\n* Glenohumeral instability (positive apprehension, relocation or positive sulcus test) or positive findings for a full thickness rotator cuff tear (positive lag sign, positive drop arm test or marked weakness with shoulder external rotation)'}, 'identificationModule': {'nctId': 'NCT03246867', 'briefTitle': 'The Acute Effects of Different Stretching Methods in Individuals With Subacromial Impingement Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'The Acute Effects of Different Stretching Methods on Posterior Shoulder Tightness, Pain, Joint Range of Motion, Subacromial Space and Strength in Individuals Having Subacromial Impingement Syndrome With Glenohumeral Internal Rotation Deficit', 'orgStudyIdInfo': {'id': '3418-GOA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isolytic stretching group', 'description': 'The participants in this group will receive isolytic stretching in modified cross body position.', 'interventionNames': ['Other: Isolytic stretching group']}, {'type': 'EXPERIMENTAL', 'label': 'Static stretching group', 'description': 'The participants in this group will receive static stretching in modified cross body position.', 'interventionNames': ['Other: Static stretching group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The participants in this group will receive no stretching. They will only be evaluated.', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Isolytic stretching group', 'type': 'OTHER', 'description': 'In modified cross body position, isolytic stretching exercises will perform five times each for 15 seconds. After each stretching patient will rest for 5 seconds. When the patient contracts the agonist muscle group with 20% muscle force, the agonist muscle group is stretched at the same time for 2-4 seconds. Afterwards active-assistive stretching is done. Evaluations will be done before and just after stretching exercise.', 'armGroupLabels': ['Isolytic stretching group']}, {'name': 'Static stretching group', 'type': 'OTHER', 'description': 'In modified cross body position, active-assistive static stretching exercises will be performed 5 times each for 15 seconds. This stretching exercise is performed 5 times with 5 seconds intervals. Evaluations will be done before and just after stretching exercise.', 'armGroupLabels': ['Static stretching group']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylül University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Sevgi Sevi YESILYAPRAK, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dokuz Eylul University'}, {'name': 'Damla GULPINAR, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Izmir Katip Celebi University'}, {'name': 'Mehmet ERDURAN, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dokuz Eylul University'}, {'name': 'Cem OZCAN, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Izmır Katip Celebi University Atatürk Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Halime Ezgi TÜRKSAN', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}