Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-24 @ 5:58 AM
Study NCT ID:
NCT02101632
Status:
COMPLETED
Last Update Posted:
2017-12-11
First Post:
2014-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myorelaxant Effect of Bee Venom(BV) Topical Skin Application in Patients With RDC/TMD Ia and Ib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-07', 'studyFirstSubmitDate': '2014-03-25', 'studyFirstSubmitQcDate': '2014-03-28', 'lastUpdatePostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Masseter muscle tension', 'timeFrame': '2 weeks', 'description': 'Masseter muscle tension at rest and in maximal voluntary contraction, electromyographic measurement \\[V\\]'}], 'secondaryOutcomes': [{'measure': 'Pain intensity of masseter muscle', 'timeFrame': '2 weeks', 'description': 'Pain intensity evaluation after 2 weeks of physiotherapy in visual analoque scale (VAS) scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TMD', 'bee venom', 'muscle tension', 'muscle pain'], 'conditions': ['Other Disorders of Muscle in Diseases Classified Elsewhere']}, 'referencesModule': {'references': [{'pmid': '18955222', 'type': 'BACKGROUND', 'citation': 'Hellner M, Winter D, von Georgi R, Munstedt K. Apitherapy: usage and experience in german beekeepers. Evid Based Complement Alternat Med. 2008 Dec;5(4):475-9. doi: 10.1093/ecam/nem052. Epub 2007 Jun 30.'}, {'pmid': '23365605', 'type': 'BACKGROUND', 'citation': 'Wieckiewicz W, Miernik M, Wieckiewicz M, Morawiec T. Does propolis help to maintain oral health? Evid Based Complement Alternat Med. 2013;2013:351062. doi: 10.1155/2013/351062. Epub 2013 Jan 9.'}, {'pmid': '12031688', 'type': 'BACKGROUND', 'citation': 'Kwon YB, Lee HJ, Han HJ, Mar WC, Kang SK, Yoon OB, Beitz AJ, Lee JH. The water-soluble fraction of bee venom produces antinociceptive and anti-inflammatory effects on rheumatoid arthritis in rats. Life Sci. 2002 May 31;71(2):191-204. doi: 10.1016/s0024-3205(02)01617-x.'}, {'pmid': '17555825', 'type': 'BACKGROUND', 'citation': 'Son DJ, Lee JW, Lee YH, Song HS, Lee CK, Hong JT. Therapeutic application of anti-arthritis, pain-releasing, and anti-cancer effects of bee venom and its constituent compounds. Pharmacol Ther. 2007 Aug;115(2):246-70. doi: 10.1016/j.pharmthera.2007.04.004. Epub 2007 May 6.'}, {'pmid': '23317340', 'type': 'BACKGROUND', 'citation': 'Seo BK, Lee JH, Sung WS, Song EM, Jo DJ. Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial. Trials. 2013 Jan 14;14:16. doi: 10.1186/1745-6215-14-16.'}, {'pmid': '25050337', 'type': 'DERIVED', 'citation': 'Nitecka-Buchta A, Buchta P, Tabenska-Bosakowska E, Walczynska-Dragon K, Baron S. Myorelaxant effect of bee venom topical skin application in patients with RDC/TMD Ia and RDC/TMD Ib: a randomized, double blinded study. Biomed Res Int. 2014;2014:296053. doi: 10.1155/2014/296053. Epub 2014 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'Topical application of BV ointment in patients with Research Diagnostic Criteria/Temporomandibular Disorder 1a and 1b (RDC/TMD) in experimental group, compared to placebo (vaseline) in control group.Application was repeated 3 times a day, during 14 days. Surface electromyography (EMG) was used to measure masseter rest tonus and maximal voluntary contraction tonus. Pain intensity was also analysed in VAS scale. Effectiveness of BV was compared with placebo in masseter myofascial pain in patients with TMD', 'detailedDescription': 'The aim of the study was evaluation of myorelaxant action of bee venom(BV) ointment, comparing to placebo.Parallel group, randomized double blinded trial was performed, including 79 patients with painful RDC/TMD 1a and 1b. Muscle tension was measured twice (TON1 and TON2) in rest muscle tonus (RMT) and maximal muscle contraction (MMC) on both sides right and left, with Easy Train Myo EMG (Version 3.1). Pain intensity was also analysed in VAS scale'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RDC/TMD 1a and 1b\n* agreement to participate in the experimental study\n\nExclusion Criteria:\n\n* bee venom allergy\n* hyperactivity on bee products\n* positive anamnesis of anaphylactic reaction after bee bites\n* skin wounds with skin surface discontinuation\n* RDC/TMD 2 and 3'}, 'identificationModule': {'nctId': 'NCT02101632', 'acronym': 'BV/TMD', 'briefTitle': 'Myorelaxant Effect of Bee Venom(BV) Topical Skin Application in Patients With RDC/TMD Ia and Ib', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Silesia'}, 'officialTitle': 'Myorelaxant Effect of Bee Venom(BV) Topical Skin Application in Patients With Research Diagnostic Criteria/Temporomandibular Disorder Ia and Ib (RDC/TMD) Randomized, Double Blinded Study', 'orgStudyIdInfo': {'id': '2012/07/B/ST6/01238'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bee Venom', 'description': 'Bee Venom Ointment 0,0005%', 'interventionNames': ['Dietary Supplement: Bee Venom Ointment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vaseline', 'description': 'Vaseline ointment', 'interventionNames': ['Other: Vaseline Ointment']}], 'interventions': [{'name': 'Bee Venom Ointment', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 weeks', 'armGroupLabels': ['Bee Venom']}, {'name': 'Vaseline Ointment', 'type': 'OTHER', 'description': '2 weeks', 'armGroupLabels': ['Vaseline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41-800', 'city': 'Zabrze', 'country': 'Poland', 'facility': 'Department of TMD and Orthodontics Silesian Medical University', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}], 'overallOfficials': [{'name': 'Stefan Baron, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Silesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Silesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'D.M.D.', 'investigatorFullName': 'Aleksandra Nitecka-Buchta', 'investigatorAffiliation': 'Medical University of Silesia'}}}}