Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-01-04 @ 8:01 PM
Study NCT ID:
NCT01922466
Status:
COMPLETED
Last Update Posted:
2015-11-24
First Post:
2013-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
East-West Collaboration Treatment Using Bee Venom Acupuncture and NSAIDs for Chronic Cervicalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C040656', 'term': 'loxoprofen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-20', 'studyFirstSubmitDate': '2013-08-08', 'studyFirstSubmitQcDate': '2013-08-11', 'lastUpdatePostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Skin Roll Test', 'timeFrame': 'Changes from baseline in skinfold thickness and pressure algometer scores at 4th and 8th week follow-up'}], 'primaryOutcomes': [{'measure': 'Visual Analogue Scale for bothersomeness', 'timeFrame': 'Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up'}], 'secondaryOutcomes': [{'measure': 'Neck Disability Index', 'timeFrame': 'Changes from baseline in NDI at 2nd, 3rd, 4th and 8th week follow-up'}, {'measure': "Depression scores on Beck's Depression Inventory", 'timeFrame': 'Changes from baseline in BDI at 4th and 8th week follow-up'}, {'measure': 'Quality of Life scores on EQ-5D', 'timeFrame': 'Changes from baseline in EQ-5D at 2nd, 3rd, 4th and 8th week follow-up'}, {'measure': 'Quality of Life scores on SF-36', 'timeFrame': 'Changes from baseline in SF-36 at 4th and 8th week follow-up'}, {'measure': 'Visual Analogue Scale for pain intensity', 'timeFrame': 'Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up'}, {'measure': 'Safety profile', 'timeFrame': 'At every visit, up to 2 months', 'description': 'Any adverse events must be documented and reported.'}, {'measure': 'Credibility test', 'timeFrame': 'Changes from baseline in credibility test at 4th week follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic neck pain', 'combined treatment between conventional and complementary alternative medical treatment', 'bee venom acupuncture', 'NSAIDs'], 'conditions': ['Chronic Non-specific, Uncomplicated Neck Pain']}, 'referencesModule': {'references': [{'pmid': '24746224', 'type': 'DERIVED', 'citation': 'Seo BK, Lee JH, Kim PK, Baek YH, Jo DJ, Lee S. Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial. Trials. 2014 Apr 21;15:132. doi: 10.1186/1745-6215-15-132.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of east-west collaborative treatment using bee venom acupuncture and NSAIDs on pain intensity, functional status and quality of life of patients with chronic cervicalgia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 65 years\n* nonspecific, uncomplicated, chronic neck pain over 3 months\n* volunteer can read and write in Korean, providing written informed consent\n\nExclusion Criteria:\n\n* exhibited abnormalities on neurological examination\n* radicular pain\n* serious spinal disorders including malignancy, vertebral fracture, spinal infection or inflammatory spondylitis\n* other chronic diseases that could affect or interfere with the therapeutic outcomes including cardiovascular disease, diabetic neuropathy, active hepatitis, fibromyalgia, rheumatoid arthritis, dementia or epilepsy\n* previous spinal surgery or scheduled procedures during the study\n* painful conditions induced by traffic accidents\n* a substantial musculoskeletal problem generating pain from an area other than the neck\n* conditions for which administration of BVA might not be safe including clotting disorders, administration of an anticoagulant agent, pregnancy and seizure disorders\n* a documented hypersensitive reaction to previous BVA treatments, bee stings or insect bites\n* positive reaction observed during a skin hypersensitivity test\n* severe psychiatric or psychological disorders\n* current use of corticosteroids, narcotics, muscle relaxants or herbal medicines to treat neck pain or any medication considered inappropriate by the investigator\n* pending lawsuits or receipt of compensation due to neck pain.'}, 'identificationModule': {'nctId': 'NCT01922466', 'briefTitle': 'East-West Collaboration Treatment Using Bee Venom Acupuncture and NSAIDs for Chronic Cervicalgia', 'organization': {'class': 'OTHER', 'fullName': 'Kyunghee University Medical Center'}, 'officialTitle': 'Clinical Research on the Efficacy and Safety of East-West Collaborative Treatment Using NSAIDs and BV on Chronic Cervical Pain; A Randomized, Controlled, Parallel, Pilot Study', 'orgStudyIdInfo': {'id': 'KHNMC-OH-IRB 2012-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bee Venom Acupuncture', 'interventionNames': ['Procedure: Bee Venom Acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'Loxoprofen', 'interventionNames': ['Drug: Loxoprofen']}, {'type': 'EXPERIMENTAL', 'label': 'EWCT : Bee Venom Acupucture and Loxoprofen', 'interventionNames': ['Procedure: Bee Venom Acupuncture', 'Drug: Loxoprofen']}], 'interventions': [{'name': 'Bee Venom Acupuncture', 'type': 'PROCEDURE', 'otherNames': ['pharmacopuncture'], 'description': 'Bee Venom 1:20,000 under BVA Increment Protocol\n\n\\- Increment Protocol as\n\n* 1st week - SC 0.2cc/day, 2 days/week\n* 2nd week - SC 0.4cc/day, 2 days/week\n* 3nd week - SC 0.8cc/day, 2 days/week', 'armGroupLabels': ['Bee Venom Acupuncture', 'EWCT : Bee Venom Acupucture and Loxoprofen']}, {'name': 'Loxoprofen', 'type': 'DRUG', 'otherNames': ['Loxonin'], 'description': '60 mg/Tab, pers os 1Tab tid, for 3 weeks', 'armGroupLabels': ['EWCT : Bee Venom Acupucture and Loxoprofen', 'Loxoprofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '134-727', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Spine Center, Kyung Hee University Hospital at Gangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Byung-Kwan Seo, PhD., KMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyunghee University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kyung Hee University Hospital at Gangdong', 'class': 'OTHER'}, {'name': 'Kyunghee University', 'class': 'OTHER'}, {'name': 'Korea Institute of Oriental Medicine', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Byung-Kwan Seo', 'investigatorAffiliation': 'Kyunghee University Medical Center'}}}}