Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-02 @ 2:54 AM
Study NCT ID:
NCT03234192
Status:
TERMINATED
Last Update Posted:
2020-01-18
First Post:
2017-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Recruiting was halted due to methodology issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-15', 'studyFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-07-26', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Rated Tennis Elbow Evaluation (PRTEE)', 'timeFrame': '30 Minutes', 'description': 'This is a 15 item self-reported questionnaire to measure perceived pain and disability in people with Lateral Epicondylosis (LE)'}, {'measure': 'QuickDASH', 'timeFrame': '30 Minutes', 'description': 'This is an 11 item questionnaire where by participants\' score themselves using a 1-5 point scale. 1 represents "no difficulty" in performing task whereas 5 represents "unable to perform task"'}], 'secondaryOutcomes': [{'measure': 'EQ-5D-5L', 'timeFrame': '30 Minutes', 'description': 'This is a visual analog scale used to assess the clients view of their overall health on a scale of 0 (worst imaginable) to 100 (best imaginable). Also, clients report issues with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each is scored on a 3 point scale.'}, {'measure': 'Range of motion', 'timeFrame': '30 Minutes', 'description': 'This will be taken at the wrist and elbow using goniometric measurements and a volar/dorsal approach at the wrist and lateral approach at the elbow. Measurements recorded will be wrist flexion and extension and elbow flexion and extension'}, {'measure': 'Grip strength', 'timeFrame': '30 Minutes', 'description': 'This will be measured using a hand held dynamometer and tested in the standard (arm at side) position and elbow extension position. Three trials on each UE will be reported in pounds'}, {'measure': 'Numeric Rating Scale for Pain', 'timeFrame': '30 Minutes', 'description': 'This scale is a single point scale from 0-10. The client picks one number to represent their pain, where 0 represents no pain and 10 represents worst pain imaginable'}, {'measure': 'Cozens Test', 'timeFrame': '30 Minutes', 'description': 'This involves the examiner resisting the wrist extension force of the client with the elbow in extension'}, {'measure': 'Mills Test', 'timeFrame': '30 Minutes', 'description': 'This is performed by palpating the lateral epicondyle while passively pronating the forearm, flexing the wrist, and extending the elbow'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['extensor carpi radialis brevis', 'Therapeutic Ultrasound', 'Astym Treatment Technique', 'Graston Treatment Technique'], 'conditions': ['Lateral Epicondylitis', 'Tennis Elbow', 'Posterolateral Rotator Instability']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effectiveness of three common techniques for the treatment of lateral epicondylosis. Through objective and subjective assessments this study will determine the effectiveness of the Astym Treatment Technique, the Graston Treatment Technique, and therapeutic ultrasound in the conservative treatment of lateral epicondylosis. It is hypothesized that the more manual Astym technique and Graston technique will produce more significant results than the more frequently utilized ultrasound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clients who are admitted to NYULMC Center for Musculoskeletal Care for outpatient occupational or physical therapy with a diagnosis of lateral epicondylosis will be included. To participate in the study participants must:\n* Be able to follow a home exercise program\n* Be able to consent to participation in the research study\n\nExclusion Criteria:\n\n* Clients who are deemed unable to consent to participation in the research study and/or unable to following a home exercise program will not be included in this study\n* Clients with additional acute orthopedic injuries and/or surgeries to the involved upper extremity will not be included in this study.\n* Clients with open wounds of the involved upper extremity that will interfere with treatment techniques will not be involved in this study.'}, 'identificationModule': {'nctId': 'NCT03234192', 'briefTitle': 'Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Randomized Clinical Controlled Study Comparing the Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.', 'orgStudyIdInfo': {'id': '16-02176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Therapeutic ultra sound', 'interventionNames': ['Procedure: Therapeutic ultra sound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Astym Treatment Technique', 'interventionNames': ['Procedure: Astym Treatment Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Graston Treatment Technique', 'interventionNames': ['Procedure: Graston Treatment Technique']}], 'interventions': [{'name': 'Therapeutic ultra sound', 'type': 'PROCEDURE', 'description': 'This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to therapeutic ultra sound treatment.', 'armGroupLabels': ['Therapeutic ultra sound']}, {'name': 'Astym Treatment Technique', 'type': 'PROCEDURE', 'description': 'This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Astym Treatment.', 'armGroupLabels': ['Astym Treatment Technique']}, {'name': 'Graston Treatment Technique', 'type': 'PROCEDURE', 'description': 'This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Graston Treatment.', 'armGroupLabels': ['Graston Treatment Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Steve Vanlew, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification.', 'accessCriteria': 'Anyone who wishes to access the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}