Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-02 @ 12:27 AM
Study NCT ID:
NCT00119704
Status:
COMPLETED
Last Update Posted:
2006-05-09
First Post:
2005-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Tennis Elbow With Botulinum Toxin
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': 'D000077330', 'term': 'Saline Solution'}], '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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-06', 'completionDateStruct': {'date': '2005-03'}, 'lastUpdateSubmitDate': '2006-05-08', 'studyFirstSubmitDate': '2005-07-06', 'studyFirstSubmitQcDate': '2005-07-06', 'lastUpdatePostDateStruct': {'date': '2006-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '100 mm visual analog scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.'}]}, 'conditionsModule': {'conditions': ['Epicondylitis, Lateral Humeral']}, 'referencesModule': {'references': [{'pmid': '16330790', 'type': 'RESULT', 'citation': 'Wong SM, Hui AC, Tong PY, Poon DW, Yu E, Wong LK. Treatment of lateral epicondylitis with botulinum toxin: a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2005 Dec 6;143(11):793-7. doi: 10.7326/0003-4819-143-11-200512060-00007.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Botulinum A toxin is effective in the treatment of tennis elbow (lateral epicondylitis).', 'detailedDescription': "Tennis elbow (lateral epicondylitis) is a common cause of chronic elbow pain and wrist extensor dysfunction in adults, affecting 1% to 3% of the general population per year.\n\nThere is currently no consensus on its optimal treatment with wide-ranging options available. The best available scientific evidence suggests that only topical non-steroidal anti-inflammatory drugs and possibly, oral non-steroidal anti-inflammatory drugs may be useful for short term pain relief, while corticosteroid injections presented both benefits and harms as a short term measure.\n\nBotulinum toxin has been reported in the treatment of lateral epicondylitis with promising results but these studies lack a control group bringing up the question whether recovery was a result of intervention or the natural history of the disease.\n\nMethod:\n\nA twin-center, prospective, randomized, double-blind, placebo-controlled trial in which all patients received either a botulinum injection or a placebo saline injection.\n\nConsecutive patients over 18 years old with tennis elbow referred to the outpatient clinic at the investigators' institution will be screened for this study. Eligible patients will be invited to participate in the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years and up\n* Pain at the lateral side of the elbow\n* Pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension\n* Pain for longer than 3 months\n\nExclusion Criteria:\n\n* Previous operations (including previous steroid injections for the disorder)\n* Nerve entrapment\n* Pregnancy and while breast-feeding\n* Presence of systemic neuromuscular disorders such as myasthenia gravis'}, 'identificationModule': {'nctId': 'NCT00119704', 'briefTitle': 'Treatment of Tennis Elbow With Botulinum Toxin', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CRE-2002.354-T'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Botulinum toxin A injection or normal saline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin, New Territories', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital'}, {'city': 'Sheung Shui, New Territories', 'country': 'Hong Kong', 'facility': 'North District Hospital'}], 'overallOfficials': [{'name': 'Andrew CF Hui, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'New World Development Company Limited', 'class': 'INDUSTRY'}]}}}