Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT06642103
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2024-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain, Muscle Strength, Motor Imagery, Body Awareness on Function and Individuals With Chronic 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2024-10-10', 'studyFirstSubmitQcDate': '2024-10-11', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Function', 'timeFrame': 'baseline', 'description': 'Fuction will be evaluated with Patient-Rated Tennis Elbow Evaluation. The Patient-Rated Tennis Elbow Evaluation (PRTEE), is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis. The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales:\n\nPain subscale - 5 items (0 = no pain, 10 = worst imaginable) Function subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items Usual activities - 4 items'}], 'secondaryOutcomes': [{'measure': 'Pain severity', 'timeFrame': 'Baseline', 'description': 'The rest, activity and night pains of the participants will be evaluated with a 10 cm Visual Analog Scale before the treatment and at the end of the 4-week application. "0" means no pain, "10" means excruciating pain. Results will be recorded in cm.'}, {'measure': 'Motor imagery', 'timeFrame': 'Baseline', 'description': "Motor imagery will be assessed through a left/right judgment task in which participants will need to recognize whether hand images correspond to their left or right side using the Recognise™ application (Neuro Orthopaedic Institute, Adelaide, Australia). For this test, participants will be seated comfortably in front of a table, with both elbows flexed at 90◦ and both index fingers placed on the bottom of the screen of an electronic tablet. Forty images of hands (20 on each side) in multiple postures, angles and skin colors will be randomly displayed in the center of the screen of the device. Participants will be given standard instructions to decide as quickly and accurately as possible whether each image is of the right or left hand by clicking on the 'left' (with left fingers) or 'right' (with right fingers) buttons shown at the bottom of the screen."}, {'measure': 'Grip strength', 'timeFrame': 'Baseline', 'description': 'The maximal grip strength of the patients will be measured with a hydraulic hand dynamometer.'}, {'measure': 'The Body Awareness', 'timeFrame': 'Baseline', 'description': 'The Body Awareness Questionnaire will be used to assess body awareness. The questionnaire consists of 18 questions. Participants will be asked to score each statement on a scale ranging from 1 (1: Not true at all) to 7 (7: Completely true) and the total score will be obtained by summing the score given for each statement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lateral Epicondylitis']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to examine the effect of muscle strength, pain, motor imagery and body awareness on function in individuals with lateral epicondylitis. The main question it aims to answer is: Do pain, motor imagery, muscle strength and body awareness have an impact on function in individuals with lateral epicondylitis?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Lateral epicondylitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a diagnosis of chronic LET by a physician and\n* a pain score \\> 3 on a visual analog scale (VAS).\n\nExclusion Criteria:\n\n* concomitant disorders of the wrist and forearm, such as elbow fracture or dislocation, and treatment with corticosteroid injections within the previous 6 months'}, 'identificationModule': {'nctId': 'NCT06642103', 'briefTitle': 'Pain, Muscle Strength, Motor Imagery, Body Awareness on Function and Individuals With Chronic Lateral Epicondylitis', 'organization': {'class': 'OTHER', 'fullName': 'KTO Karatay University'}, 'officialTitle': 'The Effect of Pain, Muscle Strength, Motor Imagery and Body Awareness on Function in Individuals With Chronic Lateral Epicondylitis', 'orgStudyIdInfo': {'id': 'KaratayUH13'}}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'state': 'Karatay', 'country': 'Turkey (Türkiye)', 'facility': 'KTO Karatay University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KTO Karatay University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Hasan Gerçek', 'investigatorAffiliation': 'KTO Karatay University'}}}}