Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT07127302
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation of Ultrasonographic Findings With Clinical Parameters in Patients With Lateral Epicondylitis
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Medical imaging, Patient data'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-11', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The relationship between clinical scores and ultrasound findings in patients with lateral epicondylitis.', 'timeFrame': '3-5 months', 'description': 'Correlation or logistic statistical analyses will be applied to reveal the relationship between ultrasound methods and clinical scores.'}], 'secondaryOutcomes': [{'measure': 'Comparison of ultrasound findings in pathological tendons and normal tendons and demonstration of the diagnostic performance of ultrasound methods', 'timeFrame': '3-5 Month', 'description': 'Ultrasound measurements of normal and patological tendons will be compared by statistical methods such as indipendent T-test or Mann Whitney U.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lateral epicondylitis', 'Ultrasonographic diagnosis', 'Doppler Ultrasound'], 'conditions': ['Lateral Epicondylitis', 'Elastography', 'Ultrasonographic Diagnosis', 'Tennis Elbow']}, 'referencesModule': {'references': [{'pmid': '18036844', 'type': 'BACKGROUND', 'citation': 'Juul-Kristensen B, Lund H, Hansen K, Christensen H, Danneskiold-Samsoe B, Bliddal H. Poorer elbow proprioception in patients with lateral epicondylitis than in healthy controls: a cross-sectional study. J Shoulder Elbow Surg. 2008 Jan-Feb;17(1 Suppl):72S-81S. doi: 10.1016/j.jse.2007.07.003. Epub 2007 Nov 26.'}, {'pmid': '32775379', 'type': 'BACKGROUND', 'citation': 'Zhou J, Yang DB, Wang J, Li HZ, Wang YC. Role of shear wave elastography in the evaluation of the treatment and prognosis of supraspinatus tendinitis. World J Clin Cases. 2020 Jul 26;8(14):2977-2987. doi: 10.12998/wjcc.v8.i14.2977.'}, {'pmid': '32851377', 'type': 'BACKGROUND', 'citation': 'Unal OF, BayramoGlu Z, AdaletlI I. Evaluation of Periarticular Soft Tissues in Patients With Juvenile Idiopathic Arthritis by Superb Microvascular Imaging and Shear Wave Elastography. Arch Rheumatol. 2020 Feb 7;35(2):264-273. doi: 10.46497/ArchRheumatol.2020.7640. eCollection 2020 Jun.'}, {'pmid': '32020529', 'type': 'BACKGROUND', 'citation': 'Gitto S, Messina C, Chianca V, Tuscano B, Lazzara A, Corazza A, Pedone L, Albano D, Sconfienza LM. Superb microvascular imaging (SMI) in the evaluation of musculoskeletal disorders: a systematic review. Radiol Med. 2020 May;125(5):481-490. doi: 10.1007/s11547-020-01141-x. Epub 2020 Feb 4.'}, {'pmid': '29789266', 'type': 'BACKGROUND', 'citation': 'Praet SFE, Ong JH, Purdam C, Welvaert M, Lovell G, Dixon L, Gaida JE, Anglim J, Manzanero S, Vlahovich N, Hughes D, Waddington G. Microvascular volume in symptomatic Achilles tendons is associated with VISA-A score. J Sci Med Sport. 2018 Dec;21(12):1185-1191. doi: 10.1016/j.jsams.2018.05.013. Epub 2018 May 15.'}, {'pmid': '28850740', 'type': 'BACKGROUND', 'citation': 'Arslan S, Karahan AY, Oncu F, Bakdik S, Durmaz MS, Tolu I. Diagnostic Performance of Superb Microvascular Imaging and Other Sonographic Modalities in the Assessment of Lateral Epicondylosis. J Ultrasound Med. 2018 Mar;37(3):585-593. doi: 10.1002/jum.14369. Epub 2017 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation and Clinical Correlation of Tendons Using Power Doppler, SWE, Microvascular Flow (MV-Flow) Imaging and B-Mode Ultrasonography in Patients with Lateral Epicondylitis.', 'detailedDescription': 'The aim of the study was to perform tendon evaluation using different ultrasonography methods in patients with a diagnosis or prediagnosis of lateral epicondylitis and to determine the correlation between clinical findings and ultrasonographic findings. Hemodynamic and elastic properties of pathologic tendons will be examined using Power Doppler, Shear Wave Elastography (SWE), Microvascular Flow (MV-Flow) and B-Mode Ultrasonography methods.\n\nIn addition, clinical scoring of the cases will be compared with positive wrist extension tests agonist resistance (Cozen test) duration of pain in the lateral epicondyle region (weeks), VAS pain score at rest, VAS pain score during activity, VAS pain score during maximal grip, VAS pain score during maximal grip, and US findings to determine the ultrasonography technique with the highest clinical correlation.\n\nIn addition, the differences between pathologic tendons and normal tendons will be evaluated to determine the Doppler US findings with the highest diagnostic performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with lateral epicondylitis or suspected lateral epicondylitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nLateral epicondylitis\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07127302', 'briefTitle': 'Correlation of Ultrasonographic Findings With Clinical Parameters in Patients With Lateral Epicondylitis', 'organization': {'class': 'OTHER', 'fullName': 'Karamanoğlu Mehmetbey University'}, 'officialTitle': 'Evaluation and Clinical Correlation of Tendons With Power Doppler, SWE, Microvascular Flow (MV-Flow) Imaging and B-Mode Ultrasonography in Patients With Lateral Epicondylitis', 'orgStudyIdInfo': {'id': '19-2025/10'}}, 'contactsLocationsModule': {'locations': [{'zip': '70110', 'city': 'Karaman', 'state': 'Merkez', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sabri Ogullar, MD, MD', 'role': 'CONTACT', 'email': 's7131210@gmail.com', 'phone': '05051020624', 'phoneExt': '0'}], 'facility': 'Karamanoglu Mehmetbey Universty', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}], 'centralContacts': [{'name': 'Sabri Oğullar, MD', 'role': 'CONTACT', 'email': 's7131210@gmail.com', 'phone': '+905051020624'}, {'name': 'Ahmet Yeşildağ, Prof. Dr.', 'role': 'CONTACT', 'email': 'ahmetysd@hotmail.com', 'phone': '+905057728297'}], 'overallOfficials': [{'name': 'Ahmet Yeşildağ, Prof.Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karamanoğlu Mehmetbey Universty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmet Yesildag', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'prof. dr.', 'investigatorFullName': 'Ahmet Yesildag', 'investigatorAffiliation': 'Karamanoğlu Mehmetbey University'}}}}