Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 7:09 PM
Study NCT ID:
NCT04392934
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2020-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conservative Physiotherapy and Acromion Morphology
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Participants are grouped according to their acromion type. First group is flat shape acromion group, second is hook shape group and the third one is curved shape acromion group. All groups are treated with the same physiotherapy protocol.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-13', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '4 weeks', 'description': 'Pain at rest and pain at activity was measured by Visual Analog Scale (VAS). High score was determined as high level of pain. Visual analog scale (VAS) was ranging from 0 cm (no pain) to 10 cm (worst imaginable pain).'}, {'measure': 'Muscle strength', 'timeFrame': '4 weeks', 'description': 'Muscle strength tests for shoulder flexion, extension, abduction, adduction, internal and external rotation were done by a dynamometer (NK-500, AIPU, Anhui, China).'}, {'measure': 'Range of motion', 'timeFrame': '4 weeks', 'description': 'Goniometric measurements were applied by a universal goniometer to determine the range of motion in terms of flexion, extension, abduction, adduction, internal and external rotation directions.'}, {'measure': 'Joint position sense', 'timeFrame': '4 weeks', 'description': "The joint position sense was evaluated by a laser pointer. During the test, 90˚ shoulder flexion and 90˚ shoulder abduction movements were evaluated. A laser pointer was fixed with a velcro 5 cm above the elbow. The patient was asked to bring the shoulder to 90˚ flexion while the patient's eyes were open and meanwhile, the measurement was made by the physiotherapist with a goniometer. The patient was asked to fix this position for 10 seconds. The projection of the laser pointer on millimeter paper was marked. The patient repeated this movement 3 times with eyes open and memorized it. The patient returned to the neutral position and closed her eyes then repeated the flexion movement 3 times and the projection of the laser pointer on millimeter paper was marked. The same procedure was performed for shoulder abduction. The deviation between the measurements was calculated."}, {'measure': 'Painful arc sign', 'timeFrame': '4 weeks', 'description': 'The patient was asked to perform active shoulder abduction, and the difference between the angle at which the pain first occurred and the angle at which the pain ended was noted during this movement pattern. Measurements were made on the affected shoulder joint by a goniometer'}, {'measure': 'Functionality', 'timeFrame': '4 weeks', 'description': 'To assess the functional levels of the patients, the Shoulder Pain and Disability Index (SPADI) was used.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physiotherapy', 'acromion morphology', 'subacromial impingement syndrome'], 'conditions': ['Subacromial Impingement Syndrome', 'Morphologic Change']}, 'descriptionModule': {'briefSummary': 'In this study, we aimed to evaluate the short-term effects of conservative physiotherapy in the subacromial impingement syndrome (SIS) and its relation to the acromion morphology.', 'detailedDescription': 'The aim of this study is to investigate the short term effects of physiotherapy in SIS patients on pain, range of motion, muscle strength, joint position sense and functionality and its relation to the acromion shape. Fifty patients (26 female, 24 male) with SIS were evaluated in this study. Patiens were divided into 3 groups according to the their acromion morphology. A conservative physiotherapy method was applied to the patients. All patients were evaluated before and 4 weeks after the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who were diagnosed (clinically and by MRI) with SIS by the physician, at a stage of II-III levels according to Neer's criteria, who were undergoing physiotherapy for the first time and who had not received any treatment from the shoulder region before were included in this study.\n\nExclusion Criteria:\n\n* Patients who had a history of fracture in the upper extremity and, surgical operation from any part of the upper extremity, who had acute cervical disc herniation or a neuromuscular disease, receiving a medical therapy for pain relief, less than 80 % participation to sessions were excluded."}, 'identificationModule': {'nctId': 'NCT04392934', 'briefTitle': 'Conservative Physiotherapy and Acromion Morphology', 'organization': {'class': 'OTHER', 'fullName': 'Hasan Kalyoncu University'}, 'officialTitle': 'The Short-term Effects of a Conservative Physiotherapy Method in Subacromial Impingement Syndrome and Its Relation to Acromion Morphology', 'orgStudyIdInfo': {'id': '2019/100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'flat shape acromion group', 'description': 'a conservative physiotherapy protocol was applied for 4 weeks', 'interventionNames': ['Procedure: a conservative physiotherapy protocol']}, {'type': 'EXPERIMENTAL', 'label': 'curved shape acromion group', 'description': 'a conservative physiotherapy protocol was applied for 4 weeks', 'interventionNames': ['Procedure: a conservative physiotherapy protocol']}, {'type': 'EXPERIMENTAL', 'label': 'hooked shape acromion group', 'description': 'a conservative physiotherapy protocol was applied for 4 weeks', 'interventionNames': ['Procedure: a conservative physiotherapy protocol']}], 'interventions': [{'name': 'a conservative physiotherapy protocol', 'type': 'PROCEDURE', 'description': "5 minutes of ultrasound (Business Line US 50, Medical Italia, Italy) at a frequency of 1 MHz and intensity of 1.5 watts/cm², 20 minutes of conventional TENS (BTL-5000, UK ) applied to the patients. Then Codman's exercises, shoulder wheel activity, isometric exercises, range of motion exercises, capsular stretching, scapular stabilization exercises, and muscle strengthening exercises were done by patients. After the treatment, cold pack was applied to the shoulder for 10 minutes. The modalities in the treatment program were applied for a total of 20 sessions 5 days per week.", 'armGroupLabels': ['curved shape acromion group', 'flat shape acromion group', 'hooked shape acromion group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27000', 'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Hasan Kalyoncu University', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}], 'overallOfficials': [{'name': 'Begumhan Turhan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hasan Kalyoncu University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasan Kalyoncu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Begümhan Turhan', 'investigatorAffiliation': 'Hasan Kalyoncu University'}}}}