Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-02-27 @ 10:52 AM
Study NCT ID:
NCT01897259
Status:
UNKNOWN
Last Update Posted:
2018-01-25
First Post:
2012-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D000075527', 'term': 'Prolotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000529', 'term': 'Complementary Therapies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2012-06-11', 'studyFirstSubmitQcDate': '2013-07-09', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Severity in pre intervention assessments', 'timeFrame': '12 months'}, {'measure': 'Symptom severity in post-intervention assessments', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Functional status score pre-intervention', 'timeFrame': '12 months', 'description': 'The secondary outcome will be by means of functional status score by means of QuickDASH (Disabilities of Arm, Shoulder, and Hand) prior to intervention.'}, {'measure': 'Functional status score severity- post intervention', 'timeFrame': '12 months', 'description': 'The secondary outcome will be the functional status score by means of the QuickDash (Disabilities of Arm, Shoulder and Hand) for post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tennis elbow', 'lateral epicondylitis'], 'conditions': ['Tennis Elbow', 'Lateral Epicondylitis']}, 'descriptionModule': {'briefSummary': 'This is a prospective study where patients with lateral epicondylitis (tennis elbow) will be randomized into one of 4 possible treatments. The purpose is to individually examine the efficacy of each treatment, and determine if one treatment method is more effective than another. The four treatments are: corticosteriod injections, prolotherapy, NSAIDs (non-steroidal anti-inflammatory drugs) combined with physical therapy, and a placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pain over the lateral epicondyle (via palpation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for less than six-months duration prior to enrollment\n* conservative treatment of tennis elbow is recommended as standard of care treatment\n* over the age of 18 and under the age of 65\n* ability to give informed consent\n\nExclusion Criteria:\n\n* treatment by a health care profession (MD, physicians assistnat, therapist, or nurse practitioner) within the previous 6 months for tennis elbow\n* congenital deformities, tendon ruptures, or fractures of the elbow within the previous 12 months\n* immobility casts or splints within the last 6 months for tennis elbow\n* co-existing elbow diagnosis (i.e. osteoarthritis or instability)\n* pregnant women, women trying to get pregnant, or breastfeeding women\n* under the age of 18 or over the age of 65'}, 'identificationModule': {'nctId': 'NCT01897259', 'briefTitle': 'Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Christine M. Kleinert Institute for Hand and Microsurgery'}, 'officialTitle': 'Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study', 'orgStudyIdInfo': {'id': '11.0566'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Corticosteroid Injections', 'description': 'Patients will receive 1 cc Kenalong 10 mg injection to the site every 6 weeks until clinical symptoms have resolved. They will also receive an anesthetic of 1cc 1% lidocaine in conjunction with the corticosteroid injection.', 'interventionNames': ['Drug: Corticosteroid Injections']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prolotherapy', 'description': 'Participants receive 1cc 50% Dextrose and 1 cc Sodium Morrhuate to the site every 6 weeks until symptoms resolve. These participants will also receive an anesthetic of 1cc 1% lidocaine.', 'interventionNames': ['Drug: Prolotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).', 'interventionNames': ['Drug: Placebo Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical Therapy', 'description': 'Participants will be prescribed NSAIDS (Diclofenac 75 mg BID) for 2 weeks. Participants will attend therapy for muscle stretches, soft tissue mobilization, and gradual strengthening.', 'interventionNames': ['Behavioral: Physical Therapy']}], 'interventions': [{'name': 'Placebo Injection', 'type': 'DRUG', 'description': 'Participants in the placebo group will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).', 'armGroupLabels': ['Placebo']}, {'name': 'Physical Therapy', 'type': 'BEHAVIORAL', 'description': 'Subjects participating in the physical therapy group will attend physical therapy and be prescribed to NSAIDS. No prolotherapy or corticosteroid injections.', 'armGroupLabels': ['Physical Therapy']}, {'name': 'Corticosteroid Injections', 'type': 'DRUG', 'description': 'Participants in the corticosteroid group will recieve corticosteroid injections (1 cc Kenalog 10 mg). They will also recieve anesthetic of 1 ml 1% lidocaine.', 'armGroupLabels': ['Corticosteroid Injections']}, {'name': 'Prolotherapy', 'type': 'DRUG', 'description': 'Subjects participating in the prolotherapy group will recieve 1 cc 50% Dextrose and Sodium Morrhuate 1 cc injections.', 'armGroupLabels': ['Prolotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christina L Kaufman, PhD', 'role': 'CONTACT', 'email': 'ckaufman@cmki.org', 'phone': '502-562-0390'}, {'name': 'Millicent L Horn, BS', 'role': 'CONTACT', 'email': 'mhorn@cmki.org', 'phone': '502-562-0307'}, {'name': 'Tuna Ozyurekoglu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Christine M. Kleinert Institute of Hand and Microsurgery', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'centralContacts': [{'name': 'Tuna Ozyurekoglu, MD', 'role': 'CONTACT', 'email': 'tozyurekoglu@kleinertkutz.com', 'phone': '502-561-4286'}, {'name': 'Millicent L Horn, BS', 'role': 'CONTACT', 'email': 'mhorn@cmki.org', 'phone': '502-562-0307'}], 'overallOfficials': [{'name': 'Tuna Ozyurekoglu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christine M. Kleinert Institute for Hand and Microsurgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christine M. Kleinert Institute for Hand and Microsurgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}