Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT04911920
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2021-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a German Version of the Patient Rated Tennis Elbow Evaluation
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2021-05-21', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire Patient Rated Tennis Elbow Evaluation', 'timeFrame': 'Ten Weeks', 'description': 'Participants are asked to complete questionnaires at each of three measurement time points.'}], 'secondaryOutcomes': [{'measure': 'Sociodemographic data', 'timeFrame': 'Ten Weeks', 'description': "The socio-demographic data includes the patient's age, sex, duration of symptoms, handedness and disease-related data"}, {'measure': 'The Disabilities of Arm Shoulder and Hand (DASH) questionnaire', 'timeFrame': 'Ten Weeks', 'description': 'The patient questionnaire measures impairment of the upper extremity'}, {'measure': 'The Patient Rated Elbow Evaluation (PREE)', 'timeFrame': 'Ten Weeks', 'description': 'It measures the elbow specific pain and limitations'}, {'measure': 'EQ-5D-5L', 'timeFrame': 'Ten Weeks', 'description': 'general measure of health for clinical and economic questions'}, {'measure': 'Patient satisfaction Questionnaire', 'timeFrame': 'Ten Weeks', 'description': 'perceived change regarding their elbow condition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Questionnaire', 'PRTEE'], 'conditions': ['Elbow Tendinitis', 'Elbow, Tennis']}, 'descriptionModule': {'briefSummary': 'The German version of the Patient Rated Tennis Elbow Evaluation (PRTEE) questionnaire is tested for reliability, validity and responsiveness.', 'detailedDescription': 'In this prospective study, patients with lateral epicondylitis will complete the PRTEE before ACP injection, 6 weeks after treatment and 2-11 days later.\n\nThe statistics will include analyses about reliability, validity and responsiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Diagnosed lateral epicondylitis\n* Receive a first ACP treatment at the Schulthess Klinik\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Lack of German language skills, which make it impossible to complete the questionnaire\n* Diseases or conditions that would prevent accurate evaluation (e.g. central neurological, psychiatric or metabolic diseases)\n* Legal incompetence\n* Recent operations on the elbow or hand (less than three months ago)'}, 'identificationModule': {'nctId': 'NCT04911920', 'acronym': 'PRTEE', 'briefTitle': 'Validation of a German Version of the Patient Rated Tennis Elbow Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Schulthess Klinik'}, 'officialTitle': 'Validation of a German Version of the Patient Rated Tennis Elbow Evaluation (PRTEE)', 'orgStudyIdInfo': {'id': 'OE-0141'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with lateral epicondylitis', 'description': 'Patients with lateral epicondylitis who are treated with at least one ACP injection.', 'interventionNames': ['Other: Questionnaire Patient Rated Tennis Elbow Evaluation']}], 'interventions': [{'name': 'Questionnaire Patient Rated Tennis Elbow Evaluation', 'type': 'OTHER', 'description': 'Participants are asked to complete questionnaires at three measurement time points.', 'armGroupLabels': ['Patients with lateral epicondylitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Miriam Marks, PhD', 'role': 'CONTACT', 'email': 'miriam.marks@kws.ch', 'phone': '+41 44 385 75 81'}], 'facility': 'Schulthess Klinik', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Miriam Marks, PhD', 'role': 'CONTACT', 'email': 'Miriam.Marks@kws.ch', 'phone': '+41 44 385 75 81'}], 'overallOfficials': [{'name': 'Miriam Marks, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schulthess Klinik'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miriam Marks', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Associate', 'investigatorFullName': 'Miriam Marks', 'investigatorAffiliation': 'Schulthess Klinik'}}}}