Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-02-03 @ 8:27 PM
Study NCT ID:
NCT02930304
Status:
COMPLETED
Last Update Posted:
2018-04-12
First Post:
2016-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Surgical Treatment Approaches in Patients With Newly Diagnosed Lateral Epicondylitis: A Randomized Clinical Trial
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': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-11', 'studyFirstSubmitDate': '2016-10-02', 'studyFirstSubmitQcDate': '2016-10-08', 'lastUpdatePostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain assessment', 'timeFrame': 'from baseline to third week after treatment sessions', 'description': 'pain intensity will de assessed by using Visual Analog Scale at rest, activity and at night. All assessment will be recorded at baseline and at the end of the three week treatment sessions'}], 'secondaryOutcomes': [{'measure': 'functional assessment', 'timeFrame': 'from baseline to third week after treatment sessions', 'description': 'functional status will be assessed by using Patient-Rated Tennis Elbow Evaluation Scale (PRTEE). All assessment will be recorded at baseline and at the end of the three week treatment sessions'}, {'measure': 'maximum grip strength evaluation', 'timeFrame': 'from baseline to third week after treatment sessions', 'description': 'maximum grip strength will be assessed with hand dynamometer both elbow flexion and extension position. All assessment will be recorded at baseline and at the end of the three week treatment sessions'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tennis elbow', 'pain', 'shock wave', 'kinesio taping'], 'conditions': ['Tennis Elbow']}, 'descriptionModule': {'briefSummary': 'Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the forearm, especially extensor carpi radialis brevi.\n\nThe aim of this study is to The compare the short-term effects of different physiotherapy approaches on pain, function and grip strength in the rehabilitation of patients with lateral epicondylitis.', 'detailedDescription': 'Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the forearm, especially extensor carpi radialis brevi. Different treatment approaches are described in the literature. The primary aim of the treatment approaches are decrease the pain and improve the functional level in patients with lateral epicondylitis. Thus, decreasing pain and regaining the functional performance in the daily living activity is essential in early diagnosed patients.\n\nThe aim of this study is to compare the short-term effects of different treatment approaches on pain, function and grip strength in the rehabilitation of patients with lateral epicondylitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with tennis elbow,\n* and the duration of symptoms was between 8 and 10 weeks,\n* and pain over the lateral epicondyle, pain during grip strength testing, and pain with one of the following tests: extensor carpi radialis test (i.e., resisted middle-finger extension), resisted wrist extension, or passive stretch of the wrist extensors.\n* Furthermore, the participants had to agree to abstain from any other form of treatment during their involvement in this study\n\nExclusion Criteria:\n\n* patients with inflammatory, autoimmune, endocrine or kidney diseases, cubital tunnel syndrome, carpal tunnel syndrome, radiculopathies due to cervical disc pathologies, additional shoulder-hand-wrist pathologies, inflammatory arthritis, upper extremity operations or traumas,\n* allergies to adhesive tape,\n* and the patients who received corticosteroid injection due to lateral epicondylitis within the last 3 months'}, 'identificationModule': {'nctId': 'NCT02930304', 'briefTitle': 'Non-Surgical Treatment Approaches in Patients With Newly Diagnosed Lateral Epicondylitis: A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Non-Surgical Treatment Approaches in Patients With Newly Diagnosed Lateral Epicondylitis: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'GO13/493'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'first physiotherapy', 'description': 'cold pack, TENS, exercise', 'interventionNames': ['Other: first physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'second physiotherapy', 'description': 'cold pack, TENS, exercise, kinesiotaping', 'interventionNames': ['Other: second physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'third physiotherapy', 'description': 'cold pack, TENS, ESWT, exercise', 'interventionNames': ['Other: third physiotherapy']}], 'interventions': [{'name': 'first physiotherapy', 'type': 'OTHER', 'otherNames': ['physiotherapy'], 'description': 'physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions', 'armGroupLabels': ['first physiotherapy']}, {'name': 'second physiotherapy', 'type': 'OTHER', 'otherNames': ['kinesiotaping'], 'description': 'physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Kinesio taping will be applied two times per week total six times in addition to conventional physiotherapy', 'armGroupLabels': ['second physiotherapy']}, {'name': 'third physiotherapy', 'type': 'OTHER', 'otherNames': ['Extracorporeal shockwave therapy (ESWT)'], 'description': 'physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Extracorporeal shockwave therapy (ESWT) will be applied one times per week total three session.', 'armGroupLabels': ['third physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University, Faculty of Health Sciences, Dept. of Physiotherapy and Rehabilitation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Leyla Eraslan', 'investigatorAffiliation': 'Hacettepe University'}}}}