Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-01-18 @ 1:17 PM
Study NCT ID:
NCT02767635
Status:
UNKNOWN
Last Update Posted:
2016-05-10
First Post:
2016-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Steroid and Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia
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': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-09', 'studyFirstSubmitDate': '2016-05-06', 'studyFirstSubmitQcDate': '2016-05-09', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of pain assessed on the visual analogue scale', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks'}], 'secondaryOutcomes': [{'measure': 'Change of grip strength by dynamometer', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks'}, {'measure': 'Change of self-assessment by Patient-Rated Tennis Elbow Evaluation', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tennis Elbow']}, 'referencesModule': {'references': [{'pmid': '27666156', 'type': 'DERIVED', 'citation': 'Guo YH, Kuan TS, Chen KL, Lien WC, Hsieh PC, Hsieh IC, Chiu SH, Lin YC. Comparison Between Steroid and 2 Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized, Double-Blind, Active Drug-Controlled Pilot Study. Arch Phys Med Rehabil. 2017 Jan;98(1):36-42. doi: 10.1016/j.apmr.2016.08.475. Epub 2016 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare two different injection sites of low dose botulinum toxin type A with steroid in treating lateral epicondylalgia.', 'detailedDescription': 'Lateral epicondylalgia or tennis elbow is a common painful elbow disorder with a prevalence of 1% to 3% in the general population and has a higher rate up to 14.5% in strenuous jobs. Botulinum toxin type A injection was an emerging option in treating lateral epicondylalgia. In this study, the patients were randomly assigned into three groups:\n\n1. Botox-Epic group received 20 units of Botox injection into lateral epicondyle;\n2. Botox-Tend group had 20 units of Botox injected into tender point of muscles;\n3. Steroid group had 40mg of triamcinolone injected into lateral epicondyle.\n\nThe aim of this randomized controlled study was to compare the effects of injection with corticosteroid and botulinum toxin type A via two different sites in patients with lateral epicondylalgia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* spontaneous local pain over lateral epicondyle of the affected elbow for more than six months and failure to respond to previous physical therapy or oral medications,\n* local tenderness around the lateral epicondyle, and\n* pain elicited or aggravated by resisted contraction of the wrist or middle finger extensors.\n\nExclusion Criteria:\n\n* local steroid injection within the past six months,\n* coexisting elbow arthritis or arthralgia,\n* previous trauma or surgery history over the lateral epicondyle,\n* pregnancy or lactation, and\n* other systemic, neuromuscular or bleeding disorders that are contraindicated to Botox injection.'}, 'identificationModule': {'nctId': 'NCT02767635', 'briefTitle': 'Comparison Between Steroid and Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Comparison Between Steroid and Two Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized Double-blind Active Drug-controlled Pilot Study', 'orgStudyIdInfo': {'id': 'BR-100-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botox-Epic group', 'description': '20 units of Botox injection into lateral epicondyle in Botox-Epic group', 'interventionNames': ['Drug: Botox-Epic']}, {'type': 'EXPERIMENTAL', 'label': 'Botox-Tend group', 'description': '20 units of Botox injected into tender point of muscles in Botox-Tend group', 'interventionNames': ['Drug: Botox-Tend']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Steroid group', 'description': '40mg of triamcinolone acetonide but not Botox injected into lateral epicondyle in Steroid group', 'interventionNames': ['Drug: triamcinolone acetonide (Steroid)']}], 'interventions': [{'name': 'Botox-Epic', 'type': 'DRUG', 'otherNames': ['onabotulinumtoxinA'], 'description': 'injected 20 units of Botox into lateral epicondyle in Botox-Epic group', 'armGroupLabels': ['Botox-Epic group']}, {'name': 'Botox-Tend', 'type': 'DRUG', 'otherNames': ['onabotulinumtoxinA'], 'description': 'injected 20 units of Botox into tender point of muscles in Botox-Tend group', 'armGroupLabels': ['Botox-Tend group']}, {'name': 'triamcinolone acetonide (Steroid)', 'type': 'DRUG', 'otherNames': ['steroid'], 'description': 'injected 40mg of triamcinolone acetonide into lateral epicondyle in Steroid group', 'armGroupLabels': ['Steroid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138', 'city': 'Tainan', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Richard Lin', 'role': 'CONTACT', 'email': 'richelin@mail.ncku.edu.tw', 'phone': 'Tel: 886-6-2353535', 'phoneExt': '2666'}], 'facility': 'Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Yu-Ching Lin, MD, MSc', 'role': 'CONTACT', 'email': 'richelin@mail.ncku.edu.tw', 'phone': '886-6-2353535', 'phoneExt': '5258'}], 'overallOfficials': [{'name': 'Yu-Ching Lin, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cheng-Kung University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Visiting Physician', 'investigatorFullName': 'Yu-Ching Lin', 'investigatorAffiliation': 'National Cheng-Kung University Hospital'}}}}