Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 1:05 AM
Study NCT ID:
NCT05213351
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2022-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Different Exercise Training in Frozen Shoulder Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2022-01-16', 'studyFirstSubmitQcDate': '2022-01-16', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline The Shoulder Pain and Disability Index at 6th and 8th week', 'timeFrame': 'Baseline,6th week and 8th week', 'description': 'The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline NPRS at 6th and 8th week', 'timeFrame': 'Baseline,6th week and 8th week', 'description': 'The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.'}, {'measure': 'Change from baseline range of motion at 6th and 8th week', 'timeFrame': 'Baseline,6th week and 8th week', 'description': 'Range of motion is the capability of a joint to go through its complete spectrum of movements.'}, {'measure': 'Change from baseline QuickDASH at 6th and 8th week', 'timeFrame': 'Baseline,6th week and 8th week', 'description': 'The purpose of the QuickDASH is to use 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.'}, {'measure': 'Change from baseline two-point discrimination at 6th and 8th week', 'timeFrame': 'Baseline,6th week and 8th week', 'description': 'The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception.'}, {'measure': 'Change from Pain Catastrophizing Scale at 6th and 8th week', 'timeFrame': 'Baseline,6th week and 8th week', 'description': 'The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.'}, {'measure': 'Change from SF-12 at 6th and 8th week', 'timeFrame': 'Baseline,6th week and 8th week', 'description': "The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['frozen shoulder', 'exercise', 'graded motor imagery'], 'conditions': ['Adhesive Capsulitis']}, 'referencesModule': {'references': [{'pmid': '39436270', 'type': 'DERIVED', 'citation': 'Yasaci Z, Celik D. Does Integration of Graded Motor Imagery Training Augment the Efficacy of a Multimodal Physiotherapy Program for Patients With Frozen Shoulder? A Randomized Controlled Trial. Clin Orthop Relat Res. 2025 Apr 1;483(4):707-716. doi: 10.1097/CORR.0000000000003252. Epub 2024 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effects of two different exercise programs in patients with frozen shoulders.', 'detailedDescription': 'After being informed about the study, all patients giving written informed and meet the inclusion criteria will be randomized a double-blind manner in a 1:1 (participant and investigator) to graded motor imagery or exercise group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged \\>60 years\n* Patients with shoulder pain of at least six months' duration secondary to tendinopathy and/or partial rotator cuff tear;\n* Patients with ability to follow simple orders; iii)\n* Patients with ability to sign to provide informed consent\n\nExclusion Criteria:\n\n* Normal passive ROM\n* External ROM \\< 30\n* To have received treatment (physiotherapy, intra-articular injection, surgery) related to the existing complaint\n* Pain \\< 3 according to the numbered pain assessment scale"}, 'identificationModule': {'nctId': 'NCT05213351', 'briefTitle': 'Two Different Exercise Training in Frozen Shoulder Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Comparison of the Effectiveness of Two Different Exercise Training in Frozen Shoulder Treatment', 'orgStudyIdInfo': {'id': '16.01.2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Graded Motor İmagery', 'description': 'Graded Motor İmagery (GMI) group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, traditional exercises and home exercises.', 'interventionNames': ['Other: Graded Motor Imagery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise', 'description': 'Exercise group will receive training involves mobilizations, stretching, specific exercises for the frozen shoulder.', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Graded Motor Imagery', 'type': 'OTHER', 'description': 'Graded Motor Imagery program will be performed two times a week for six consecutive weeks and will include the following three steps: laterality training, imagined movements, and mirror therapy.\n\n1. Right-left discrimination training (lateralization training)\n2. Imagination of hand movements (motor imagery):\n3. Mirror therapy Treatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc.', 'armGroupLabels': ['Graded Motor İmagery']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'Treatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'İstanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Derya Çelik', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Zeynal YASACI', 'investigatorAffiliation': 'Istanbul University'}}}}