Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-29 @ 6:53 AM
Study NCT ID:
NCT00817232
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2009-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Microcurrent for Treatment of Tennis Elbow
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-18', 'studyFirstSubmitDate': '2009-01-05', 'studyFirstSubmitQcDate': '2009-01-05', 'lastUpdatePostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tendon pathology as indicated by sonography', 'timeFrame': 'baseline, 3 weeks, 6 weeks, 4 months'}, {'measure': 'Patient-Rated Global Change Score', 'timeFrame': '3 weeks, 6 weeks, 4 months'}], 'secondaryOutcomes': [{'measure': 'Pain Free Grip Strength', 'timeFrame': 'baseline, 3 weeks, 6 weeks, 4 months'}, {'measure': 'Patient-rated Tennis Elbow Questionnaire', 'timeFrame': 'baseline, 3 weeks, 6 weeks, 4 months'}, {'measure': 'Patient-Specific Functional Scale', 'timeFrame': 'baseline, 3 weeks, 6 weeks, 4 months'}, {'measure': 'Adverse events', 'timeFrame': '3 weeks, 6 weeks, 4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tennis elbow', 'microcurrent', 'tissue healing'], 'conditions': ['Tennis Elbow']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.electrotherapy.org', 'label': 'application of electrotherapy'}]}, 'descriptionModule': {'briefSummary': 'Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain and disability. Treatment of the disorder is not always successful, and it often recurs or becomes chronic. More effective management options are required. There is evidence that electric microcurrent can promote tissue healing and symptom resolution in various chronic hard and soft tissue disorders, but few human studies investigating its use with chronic tendon problems. It is an easily applied therapy with very few reports of side effects. It can be applied at home using a portable unit and, if it is clinically effective, may also prove more cost effective than other therapies.\n\nA clinical trial is planned to evaluate the therapy but, in the absence of relevant published evidence, a preliminary study is required to look for a treatment effect and inform a power calculation for sample size, The study will also allow some investigation of dose-dependence, which is a key issue in many forms of electrotherapy. Finally it will enable evaluation of elements of the full trial protocol so that any weaknesses can be addressed before it begins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptoms of tennis elbow for at least 3 months\n* clinical diagnosis of tennis elbow\n\nExclusion Criteria:\n\n* significant symptom improvement in previous month\n* receipt of any active treatment for the condition in the previous month\n* currently under the care of another health professional for tennis elbow\n* current cervical radiculopathy\n* other pathology affecting distal upper limb'}, 'identificationModule': {'nctId': 'NCT00817232', 'briefTitle': 'Effectiveness of Microcurrent for Treatment of Tennis Elbow', 'organization': {'class': 'OTHER', 'fullName': 'University of Hertfordshire'}, 'officialTitle': 'Effectiveness of Microcurrent in the Treatment of Chronic Tennis Elbow - a Preliminary Trial', 'orgStudyIdInfo': {'id': 'HEPEC/10/08/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment 1', 'description': '50 microamp amplitude', 'interventionNames': ['Device: Microcurrent (Elexoma Medic)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment 2', 'description': '500 microamp amplitude', 'interventionNames': ['Device: Microcurrent (Elexoma Medic)']}], 'interventions': [{'name': 'Microcurrent (Elexoma Medic)', 'type': 'DEVICE', 'otherNames': ['Elexoma Medic'], 'description': 'monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days', 'armGroupLabels': ['Treatment 1', 'Treatment 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AL10 9AB', 'city': 'Hatfield', 'state': 'Hertfordshire', 'country': 'United Kingdom', 'facility': 'University of Hertfordshire', 'geoPoint': {'lat': 51.76338, 'lon': -0.22419}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hertfordshire', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Leon Poltawski', 'oldOrganization': 'University of Hertfordshire'}}}}