Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT04838002
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2021-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}, {'id': 'D010146', 'term': 'Pain'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-07', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-07', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': '1 min.', 'description': 'pain evaluation, higher scores mean a worse outcome.'}, {'measure': 'Patient-Rated Tennis Elbow Evaluation', 'timeFrame': '5 min.', 'description': 'Scale, Higher scores represent higher level of pain and disability.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lateral Epicondylitis', 'Pain']}, 'descriptionModule': {'briefSummary': 'To date, focused and radial types of extracorporeal shock wave therapy have been effectively used in lateral epicondylitis. However, studies directly addressing a comparison between radial and focused types of extracorporeal shock wave therapy in lateral epicondylitis have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused extracorporeal shock wave therapy options on lateral epicondylitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of lateral epicondylitis\n* be aged ≥18 at the time of diagnosis\n* be give informed consent\n\nExclusion Criteria:\n\n* be have not completed the assessment process.\n* elbow deformity\n* psychological illness'}, 'identificationModule': {'nctId': 'NCT04838002', 'briefTitle': 'The Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Comparative Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis: A Randomised Sham-controlled Trial', 'orgStudyIdInfo': {'id': 'Yuzuncu Yil University Turkey'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Focus ESWT', 'interventionNames': ['Device: Extracorporeal shock wave']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radial ESWT', 'interventionNames': ['Device: Extracorporeal shock wave']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham ESWT', 'interventionNames': ['Device: Extracorporeal shock wave']}], 'interventions': [{'name': 'Extracorporeal shock wave', 'type': 'DEVICE', 'description': 'Focus and Radial types Extracorporeal shock wave therapy', 'armGroupLabels': ['Focus ESWT', 'Radial ESWT', 'Sham ESWT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Van', 'country': 'Turkey (Türkiye)', 'facility': 'Yuzuncu Yil University', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}], 'overallOfficials': [{'name': 'Şeyhmus Kaplan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yuzuncu Yil University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Şeyhmus KAPLAN', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Şeyhmus KAPLAN', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}