Viewing Study NCT01205958


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Study NCT ID: NCT01205958
Status: UNKNOWN
Last Update Posted: 2010-09-21
First Post: 2010-09-14
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: The Effect of East-West Collaborative Medicine on Chronic Cervical Pain
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'C043940', 'term': 'pyranoprofen'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-09-20', 'studyFirstSubmitDate': '2010-09-14', 'studyFirstSubmitQcDate': '2010-09-20', 'lastUpdatePostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores on the Visual Analogue Scale(VAS)', 'timeFrame': '7 week'}], 'secondaryOutcomes': [{'measure': 'Neck disability index', 'timeFrame': '7 week', 'description': 'Neck disability index : questionnaire for measuring how much neck pain affects ability of daily activities'}, {'measure': 'Beck depression inventory', 'timeFrame': '7 week', 'description': 'Beck depression inventory : for assessing depression'}, {'measure': 'SF-36', 'timeFrame': '7 week', 'description': 'questionnaire for measuring health-related quality of life'}, {'measure': 'EQ-5D(EuroQol-5 dimension)', 'timeFrame': '7 week', 'description': 'questionnaire for measuring health-related quality of life'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cervical pain', 'Neck pain', 'western medicine', 'oriental medicine', 'acupuncture', 'needle'], 'conditions': ['Chronic Neck Pain']}, 'referencesModule': {'references': [{'pmid': '24171895', 'type': 'DERIVED', 'citation': 'Cho JH, Nam DH, Kim KT, Lee JH. Acupuncture with non-steroidal anti-inflammatory drugs (NSAIDs) versus acupuncture or NSAIDs alone for the treatment of chronic neck pain: an assessor-blinded randomised controlled pilot study. Acupunct Med. 2014 Feb;32(1):17-23. doi: 10.1136/acupmed-2013-010410. Epub 2013 Oct 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of East-West collaborative medicine on chronic cervical pain.', 'detailedDescription': 'Design: This is a randomized, controlled study.\n\nParticipants: 45 participants with chronic cervical pain are recruited and randomly assigned to three groups.\n\nIntervention: Over an three-week period, one group(n=15) gets western medicine treatment(drug medication); another group(n=15) gets oriental medicine treatment(individualized needling 2-3 times a week); the other group(n=15) gets western medicine plus oriental medicine treatment for 3 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- presence of Chronic neck pain\n\nExclusion Criteria:\n\n* Cancer\n* Spinal infection\n* ankylosing spondylosis\n* myelopathy\n* moderate hypertension or more\n* serious mental disease\n* other skeletomuscular disease\n* history of operation or acupuncture treatment about spinal disease'}, 'identificationModule': {'nctId': 'NCT01205958', 'briefTitle': 'The Effect of East-West Collaborative Medicine on Chronic Cervical Pain', 'organization': {'class': 'OTHER', 'fullName': 'Kyunghee University Medical Center'}, 'officialTitle': 'Clinical Trial to Evaluate the Effect of East-West Collaborative Medicine on Chronic Cervical Pain: a Pilot Study', 'orgStudyIdInfo': {'id': 'KHU 20091458'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'medication(Zaltoprofen)', 'interventionNames': ['Procedure: acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acupuncture', 'interventionNames': ['Procedure: acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zalprofen plus Acupuncture', 'interventionNames': ['Procedure: acupuncture']}], 'interventions': [{'name': 'acupuncture', 'type': 'PROCEDURE', 'otherNames': ['Zaltoprofen'], 'description': 'Over an three-week period, one group(n=15) gets western medicine treatment(drug medication); another group(n=15) gets oriental medicine treatment(individualized needling 2-3 times a week); the other group(n=15) gets western medicine plus oriental medicine treatment for 3 weeks', 'armGroupLabels': ['Acupuncture', 'Zalprofen plus Acupuncture', 'medication(Zaltoprofen)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '134-727', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'JaeHeung Cho, OMD', 'role': 'CONTACT', 'email': 'vetkong95@hanmail.net', 'phone': '+82-2-440-7581'}], 'facility': 'Kyunghee University East West Neo Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yu-Jeong Cho, OMD', 'role': 'CONTACT', 'email': 'jamyunghwa@hotmail.com', 'phone': '+82-2-440-7575'}], 'overallOfficials': [{'name': 'Jun-Hwan Lee, OMD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jun-Hwan Lee / Department of Oriental Rehabilitation Medicine', 'oldOrganization': 'College of Oriental Medicine, Kyung Hee University'}}}}