Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT07293702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IASTM Effects on Pain, Functionality, and Proprioception in Subacromial Impingement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D017695', 'term': 'Soft Tissue Injuries'}], '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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants in the first group underwent conventional physiotherapy interventions for 4 weeks, 3 days per week.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-07', 'studyFirstSubmitDate': '2025-12-01', 'studyFirstSubmitQcDate': '2025-12-07', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'The Visual Analog Scale (VAS) is a tool used to measure pain intensity as a single-dimensional construct across different adult populations. It typically consists of a horizontal or vertical line measuring 10 cm in length. On this scale, a score of 0 indicates no pain, while a score of 10 represents the worst pain imaginable.'}, {'measure': 'Range of motion', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'Shoulder flexion, abduction, internal rotation, and external rotation range of motion will be assessed using a universal goniometer while the patient is positioned in supine and performs the movements actively.'}, {'measure': 'The Disabilities of the Arm, Shoulder and Hand (DASH)', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a scale that evaluates functional status and capability following injuries or disorders affecting the upper extremity. The DASH consists of 30 items. These items assess difficulties encountered during specific tasks, as well as pain, numbness, stiffness, weakness, sleep problems, self-confidence, and participation in social activities. Scores range from 0 to 100, with higher scores indicating greater impairment in upper extremity function.'}], 'secondaryOutcomes': [{'measure': 'Joint position sense', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'To evaluate shoulder proprioception, joint position sense will be measured at 60° of shoulder flexion and 60° of shoulder abduction. During the assessment, participants will be positioned in standing and guided to the target angles by the physiotherapist using a goniometer. In each position, participants will be asked to maintain 60° of flexion or 60° of abduction for 10 seconds with their eyes open and to memorize the perceived position. They will then be instructed to reproduce the same movement with their eyes closed. The difference between the angle measured with eyes open and the angle reproduced with eyes closed will be recorded as the joint position sense error (error angle).'}, {'measure': 'Rotator cuff quality of life Index', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': "Quality of life in individuals with shoulder pathology was evaluated using the Rotator Cuff Quality of Life (RC-QoL) questionnaire. The RC-QoL consists of 34 items and five subscales. Results are interpreted in a positive direction; as the RC-QoL score increases, the individual's shoulder-related quality of life is considered to have improved, and symptoms are regarded as reduced."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Subakromial Impingement Syndrome', 'IASTM', 'Shoulder'], 'conditions': ['Subacromial Impingement Syndrome', 'Massage', 'Instrument-Assisted Soft Tissue Mobilization', 'Soft Tissue Injuries']}, 'descriptionModule': {'briefSummary': 'The aim of this study will be to investigate the effects of Instrument-Assisted Soft Tissue Mobilization (IASTM), applied in addition to a conventional exercise program, on pain, range of motion, proprioception, functionality, and quality of life in individuals with Subacromial Impingement Syndrome (SIS).', 'detailedDescription': 'The aim of this study will be to investigate the effects of Instrument-Assisted Soft Tissue Mobilization (IASTM), applied in addition to a conventional exercise program, on pain, range of motion, proprioception, functionality, and quality of life in individuals with Subacromial Impingement Syndrome (SIS).\n\nA total of 38 participants will be included in the study and will be randomly assigned to either the Conventional Exercise Group or the IASTM Group. Both groups will receive treatment for 4 weeks, three sessions per week, for a total of 12 sessions.\n\nBefore the intervention, both groups will be assessed for pain (VAS), range of motion (goniometer), joint position sense (goniometer), functionality (Disabilities of the Arm, Shoulder and Hand - DASH), and quality of life (Rotator Cuff Quality of Life - RC-QoL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals diagnosed with SIS by MRI\n* Men and women between 40 and 60 years of age\n* Individuals with symptoms persisting for at least one month\n* Individuals with a minimum of 60° of shoulder flexion and abduction range of motion\n\nExclusion Criteria:\n\n* Individuals with a history of surgery on the affected arm\n* Individuals with an open wound on the arm\n* Individuals with an active infection\n* Individuals with inflammatory joint disease\n* Individuals with malignant or benign tumors were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT07293702', 'briefTitle': 'IASTM Effects on Pain, Functionality, and Proprioception in Subacromial Impingement', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': '**Effect of Instrument-Assisted Soft Tissue Mobilization on Pain, Functionality, and Proprioception in Individuals With Subacromial Impingement Syndrome**', 'orgStudyIdInfo': {'id': 'E-10840098-202.3.02-6969'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional exercise group', 'description': 'Conventional exercises will be applied.', 'interventionNames': ['Other: Conventional exercise group']}, {'type': 'EXPERIMENTAL', 'label': 'IASTM group', 'description': 'In addition to the conventional exercises, Instrument-Assisted Soft Tissue Mobilization (IASTM) will be applied.', 'interventionNames': ['Other: Conventional exercise group', 'Other: IASTM group']}], 'interventions': [{'name': 'Conventional exercise group', 'type': 'OTHER', 'description': "All participants will receive a standardized electrotherapy program in a clinical setting, consisting of TENS (100 Hz, 30 minutes), ultrasound (1.5 W/cm², 8 minutes), and a 15-minute cold-pack application, delivered three times per week for four weeks. In addition to electrotherapy, participants in the conventional exercise group will perform a physiotherapist-guided exercise program aimed at improving shoulder flexion, abduction, internal and external rotation through stretching and range-of-motion exercises. The program will include Codman exercises, wand exercises, finger-ladder activities, and condition-appropriate strengthening exercises, progressed according to each participant's pain level and tolerance.", 'armGroupLabels': ['Conventional exercise group', 'IASTM group']}, {'name': 'IASTM group', 'type': 'OTHER', 'description': 'Participants in the IASTM group will receive Instrument-Assisted Soft Tissue Mobilization in addition to the conventional treatment program, three days per week for four weeks, for a total of 12 sessions. The IASTM technique will be applied to the subscapularis, anterior deltoid, biceps brachii, upper trapezius, supraspinatus, infraspinatus, teres major, teres minor, and posterior deltoid muscles.\n\nFor each muscle group, the treatment will be administered for 20 seconds in a parallel direction and 20 seconds in a perpendicular direction, using sweep and brush techniques at an angle of approximately 45 degrees.', 'armGroupLabels': ['IASTM group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34820', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'BURAK MENEK, PhD', 'role': 'CONTACT', 'email': 'bmenek@medipol.edu.tr', 'phone': '+905444761640'}, {'name': 'Ahmet Mesut Zan', 'role': 'CONTACT', 'email': 'ahmetmesutzan@gmail.com'}], 'facility': 'Istanbul Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Burak Menek, PhD', 'role': 'CONTACT', 'email': 'bmenek@medipol.edu.tr', 'phone': '05444761640'}, {'name': 'Ahmet Mesut Zan', 'role': 'CONTACT', 'email': 'ahmetmesutzan@gmail.com', 'phone': '05444761640'}], 'overallOfficials': [{'name': 'Burak Menek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'burak menek', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}