Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-29 @ 2:28 AM
Study NCT ID:
NCT04454632
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2020-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mirror Therapy in Patients With Frozen Shoulder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D002062', 'term': 'Bursitis'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D018771', 'term': 'Arthralgia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088762', 'term': 'Mirror Movement Therapy'}, {'id': 'D056228', 'term': 'Feedback, Sensory'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001676', 'term': 'Biofeedback, Psychology'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}, {'id': 'D025461', 'term': 'Feedback, Physiological'}, {'id': 'D006706', 'term': 'Homeostasis'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2020-06-30', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Change from Baseline, 6 weeks and 10 weeks', 'description': 'Pain intensity was obtained using a Visual Analog Scale (VAS). VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with "No Pain" (score of zero) on the left side up to "severe pain" on the right side. The patient was asked to mark the line point that represented his or her worst pain in the past week during daily rutine.'}, {'measure': 'Range of Motion (ROM)', 'timeFrame': 'Change from Baseline, 6 weeks and 10 weeks', 'description': 'Range of motion is the measurement of the amount of movement around a joint as a flexion, abduction, external rotation and internal rotation (degree). Measurement performed with universal goniometer.'}, {'measure': 'Proprioception', 'timeFrame': 'Change from Baseline, 6 weeks and 10 weeks', 'description': 'Proprioception is the sense of self-movement and body position. A joint position error test (JPET) was used for proprioception measurement. JPET is a deviation of the ability to reposition the joint to the target position which fifty percent of active flexion ROM.'}, {'measure': 'Shoulder Pain and Disability Index (SPADI)', 'timeFrame': 'Change from Baseline, 6 weeks and 10 weeks', 'description': 'The shoulder pain and disability index is a self-administered questionnaire that consists of two dimensions, one for pain and the other one for functional activities on the shoulder. The total score is defining as a percent. 0 for best score 100 for worst score.'}, {'measure': 'Modified Constant-Murley Score (CMS)', 'timeFrame': 'Change from Baseline, 6 weeks and 10 weeks', 'description': 'The modified Constant-Murley score is a questionnaire for shoulder injuries that consists of four dimensions, pain, activities of daily living, range of movement, and power. Pain and activities of daily living are considered subjective scores therefore the range of movement and power considered objective score. 100 for best score 0 for worst score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frozen Shoulder', 'visual feedback', 'proprioception', 'pain insensitivity', 'shoulder pain'], 'conditions': ['Pain', 'Frozen Shoulder']}, 'referencesModule': {'references': [{'pmid': '30056414', 'type': 'RESULT', 'citation': 'Baskaya MC, Ercalik C, Karatas Kir O, Ercalik T, Tuncer T. The efficacy of mirror therapy in patients with adhesive capsulitis: A randomized, prospective, controlled study. J Back Musculoskelet Rehabil. 2018;31(6):1177-1182. doi: 10.3233/BMR-171050.'}, {'pmid': '20202141', 'type': 'RESULT', 'citation': 'Sato K, Fukumori S, Matsusaki T, Maruo T, Ishikawa S, Nishie H, Takata K, Mizuhara H, Mizobuchi S, Nakatsuka H, Matsumi M, Gofuku A, Yokoyama M, Morita K. Nonimmersive virtual reality mirror visual feedback therapy and its application for the treatment of complex regional pain syndrome: an open-label pilot study. Pain Med. 2010 Apr;11(4):622-9. doi: 10.1111/j.1526-4637.2010.00819.x. Epub 2010 Mar 1.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/30056414/', 'label': 'Mirror therapy in frozen shoulder'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/20202141/', 'label': 'visual feedback therapy'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study compares mirror therapy and visual feedback treatment with the control group in frozen shoulder patients.', 'detailedDescription': 'Thirty-six individuals divided three groups as mirror therapy, visual feedback, and control groups were included in the study for 15 sessions of treatment. All individuals received basic treatment as ultrasound, transcutaneous electrical nerve stimulation, cold pack, stretching exercises, glenohumeral range of motion exercises, scapulothoracic exercises. The mirror group bilateral exercised with an affected arm behind the mirror; visual feedback group bilateral exercised by seeing both arms in the mirror; control group bilateral exercised without a mirror for 10 minutes after every session. Pain severity was evaluated with the "Visual Analogue Scale (VAS)", ROM and proprioception were measured with a universal goniometer, and functional status was evaluated with "shoulder pain and disability index (SPADI)" and "Modified Constant Score". Evaluations were made before, day after the treatment and 4 weeks after the treatment by the same researcher. Data analysis was performed with SPSS.23.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who were diagnosed with "Unilateral Frozen Shoulder" by the specialist;\n* Normal radiological imaging;\n* Aged between 18-75 years old;\n* Symptoms persist for 2-12 months.\n\nExclusion Criteria:\n\n* If patients had following comorbidities: rotator cuff injury, cervical radiculopathy, romatological diseases, neurological diseases, fracture, tumour, congenital deformities, dislocation or sublocation, surgery in the shoulder, uncontrolled hypertension or diabetes mellitus;\n* Pregnancy;\n* Patients who had previously received physical therapy;\n* Patients having problems in the perception of tests and exercises were excluded from this study'}, 'identificationModule': {'nctId': 'NCT04454632', 'briefTitle': 'The Effect of Mirror Therapy in Patients With Frozen Shoulder', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Examination of the Effectiveness of Mirror Therapy in the Treatment of Patients With Frozen Shoulder: A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Dr. Lutfi Kirdar Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirror therapy group', 'description': 'The number of participants in this group is anticipated to be 12. In addition to basic treatment, the mirror therapy group bilateral exercised with the affected arm behind the mirror for 10 minutes after every session. Participants in this group perform three exercises as glenohumeral flexion, abduction, and rotation.', 'interventionNames': ['Other: Mirror therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Visual feedback group', 'description': 'The number of participants in this group is anticipated to be 12. In addition to basic treatment, the visual feedback group bilateral exercised by seeing both arms in the mirror for 10 minutes after every session. Participants in this group perform three exercises as glenohumeral flexion, abduction, and rotation while seeing both arms in the mirror.', 'interventionNames': ['Other: Visual feedback']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The number of participants in this group is anticipated to be 12. In addition to basic treatment, the control group bilateral exercised without a mirror for 10 minutes after every session. Participants in this group perform three exercises as glenohumeral flexion, abduction, and rotation while seeing both arms in the mirror.'}], 'interventions': [{'name': 'Mirror therapy', 'type': 'OTHER', 'description': 'affected arm stay behind the mirror while exercising', 'armGroupLabels': ['Mirror therapy group']}, {'name': 'Visual feedback', 'type': 'OTHER', 'description': 'visual feedback from mirror', 'armGroupLabels': ['Visual feedback group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34865', 'city': 'Istanbul', 'state': 'Kartal', 'country': 'Turkey (Türkiye)', 'facility': 'Dr. Lutfi Kirdar City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'TUGBA KURU ÇOLAK, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Marmara University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}