Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-28 @ 2:24 PM
Study NCT ID:
NCT04319250
Status:
COMPLETED
Last Update Posted:
2021-03-01
First Post:
2020-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness Of Ischemic Compression And IASTM In Trigger Point Treatment In Patients With Rotator Cuff Tear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019050', 'term': 'Acupressure'}, {'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)', 'timeFrame': 'Change from Baseline at 6 weeks', 'description': 'This is a questionnaire that identifies both functionality and symptoms that can be used in arm, elbow and hand problems. High scores of individuals mean that functional dysfunction is high. Ratings are made between 0 and 100.'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'Change from Baseline at 6 weeks', 'description': 'The levels of pain felt at rest / activity / night were measured using Visual Analogue Scale (VAS).'}, {'measure': 'Shoulder Range of Motion (ROM)', 'timeFrame': 'Change from Baseline at 6 weeks', 'description': 'EHA evaluations of flexion, abduction, internal rotation and external rotation of the shoulder joint were performed in the supine position using the universal goniometer.'}, {'measure': 'Active trigger points', 'timeFrame': 'Change from Baseline at 6 weeks', 'description': 'Active trigger points were evaluated by palpation method according to Travell and Simons criteria. Scalene, upper trapezius, levator scapula, supraspinatus, infraspinatus, subskapularis, teres minor, teres major, deltoid anterior and posterior group fibers, pectoralis major, pectoralis minor, biceps brachii muscles were evaluated with palpation method in terms of trigger point presence.'}, {'measure': 'Pain Pressure Threshold (PPT)', 'timeFrame': 'Change from Baseline at 6 weeks', 'description': 'Wagner Force One ™ FDIX" digital algometer was used to evaluate the pain threshold. Measurements were recorded in kg / cm².'}, {'measure': 'The American Shoulder and Elbow Surgeons Standardized Shoulder Assesment Form (ASES)', 'timeFrame': 'Change from Baseline at 6 weeks', 'description': 'This score consists of 1 questioning pain and 10 questions questioning daily life activities.The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.'}, {'measure': 'Emotional state', 'timeFrame': 'Change from Baseline at 6 weeks', 'description': 'The emotional states of the cases were evaluated using the Hospital Anxiety and Depression Scale (HAD), which consists of 14 questions. (HAD). This scale has a 7-question anxiety (HAD-A) subscale that evaluates the anxiety state, and a 7-question depression (HAD-D) subscale that evaluates the state of depression, and a four-point likert scale is used to answer the questions. For the total score of each sub-score, 0-7 points are normal, 8-10 points are at the border, and 11 points are defined as abnormal'}, {'measure': 'Global Rating of Change (GRC) scale', 'timeFrame': 'After 6 weeks treatment', 'description': 'Patient Satisfaction was assessed Global Rating of Change (GRC) scale. The scale used included 5 points (-2: I am much worse. -1: I am worse, 0: I am the same, +1: I am better, +2: I am much better).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ischemic compression', 'instrument assisted soft tissue mobilization', 'trigger point'], 'conditions': ['Rotator Cuff Tears', 'Shoulder Pain', 'Myofascial Trigger Point Pain']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the effects of ischemic compression and IASTM techniques on pain, EHA, functionality, anxiety and depression in patients with the diagnosis of RM tear and presence of ATN. In addition, ischemic compression and EDYDM methods were aimed to compare and to reveal which application would be more useful.', 'detailedDescription': 'In this study participants were randomly divided into two groups. While ischemic compression was applied to one group for the determined active trigger points, instrument assisted soft tissue mobilization (IASTM) was applied to the other group for active trigger points. In addition to the treatment, both groups were subjected to a joint rehabilitation program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between 40-65 years old\n* Having been diagnosed with partial RM rupture\n* RM rupture in MRI image\n* At least 3 ATNs in the shoulder complex\n* Hawkins-Kennedy and Empty Can tests positive Symptoms for at least 3 months\n\nExclusion Criteria:\n\n* Sensory problems in the back and shoulders,\n* Shoulder instability\n* Osteoarthritis in the shoulder joint area\n* Glenoid or bone fracture\n* Frozen shoulder pathology\n* Massive RM rupture\n* Rheumatological joint problems\n* Shoulder surgery history'}, 'identificationModule': {'nctId': 'NCT04319250', 'briefTitle': 'The Effectiveness Of Ischemic Compression And IASTM In Trigger Point Treatment In Patients With Rotator Cuff Tear', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Aydın University'}, 'officialTitle': 'The Effectiveness Of Ischemic Compression And Instrument Assisted Soft Tissue Mobilization In Trigger Point Treatment In Patients With Rotator Cuff Tear', 'orgStudyIdInfo': {'id': 'Büşra Aksan Sadıkoğlu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Ischemic compression and rehabilitation program applied to the group 1', 'interventionNames': ['Other: ischemic compression', 'Other: Rehabilitation Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'IASTM and rehabilitation program applied to the group 2', 'interventionNames': ['Other: IASTM', 'Other: Rehabilitation Program']}], 'interventions': [{'name': 'ischemic compression', 'type': 'OTHER', 'description': 'ATNs detected in a total of 13 muscles around the shoulder were applied constant pressure at the level of pain tolerated with the thumb (discomfort severity level 7 to 8 out of 10) and for 90 seconds. This method was applied twice a week for 6 weeks.', 'armGroupLabels': ['Group 1']}, {'name': 'IASTM', 'type': 'OTHER', 'description': 'In order to apply EDYDM in the treatment of ATN, titanium plated stainless steel was divided into two parts, front and back, with two tools. The sweep was applied to the anterior muscle fibers at an angle of 45 ° for 40 seconds.\n\nFor each TN, continuous pressure was applied with swivel movement at tolerable pain level (discomfort severity level 7 to 8 out of 10) for 1 minute. The back group muscles were applied in the same way.', 'armGroupLabels': ['Group 2']}, {'name': 'Rehabilitation Program', 'type': 'OTHER', 'description': 'A rehabilitation program consisting of exercises and manual therapy used in the conservative treatment of rotator cuff tear for both groups was applied twice a week for 6 weeks.', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Aydin University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Aydın University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator (MSc)', 'investigatorFullName': 'Büşra Aksan Sadıkoğlu', 'investigatorAffiliation': 'Istanbul Aydın University'}}}}