Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT04035018
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2019-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Pharmacopuncture for Chronic Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2019-07-24', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale of neck pain', 'timeFrame': 'week 6', 'description': 'Minimum 0, Maximum 100. Higher values represent a worse outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Neck Pain']}, 'referencesModule': {'references': [{'pmid': '39725423', 'type': 'DERIVED', 'citation': 'Lee SM, Kim SJ, Nam D, Park YC, Kim EJ, Ha IH, Lee YJ. Comparison of preference-based health-related quality of life measures for chronic neck pain: a pooled analysis of data from three RCTs. BMJ Open. 2024 Dec 26;14(12):e086104. doi: 10.1136/bmjopen-2024-086104.'}, {'pmid': '37993844', 'type': 'DERIVED', 'citation': 'Kim D, Kim ES, Song HJ, Park SY, Park KS, Lee YJ, Ha IH. An economic evaluation of pharmacopuncture versus usual care for chronic neck pain: a pragmatic randomized controlled trial. BMC Health Serv Res. 2023 Nov 23;23(1):1286. doi: 10.1186/s12913-023-10325-w.'}, {'pmid': '35011752', 'type': 'DERIVED', 'citation': 'Park KS, Kim S, Kim C, Seo JY, Cho H, Kim SD, Lee YJ, Lee J, Ha IH. A Comparative Study of the Effectiveness of Pharmacopuncture Therapy for Chronic Neck Pain: A Pragmatic, Randomized, Controlled Trial. J Clin Med. 2021 Dec 21;11(1):12. doi: 10.3390/jcm11010012.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators will evaluate the efficacy and safety of pharmacopuncture therapy for chronic neck pain compared to physical therapy.', 'detailedDescription': 'This study is prgmatic RCT of pharmacopuncture therapy for chronic neck pain compared to physical therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Neck pain more than 6 months\n* VAS of neck pain more than 5\n* Age between 17 and 70 years old\n* Participants who wrote informed consent\n\nExclusion Criteria:\n\n* Migration of cancer reaching to spine, fracture of spine\n* Progressive neurologic deficits or severe neurologic deficits\n* Cancer, fibromyalgia, RA, or goat\n* Stroke, MI, kidney disease, dimentia, diabetic neuropathy, or epilepsy\n* Participants taking steroid, immunosuppressant, or psychotropic medication\n* Hemorrhagic disease, severe diabetes or taking anticoagulant drug\n* Participants who took NSAIDs or pharmacopuncture within 1 week\n* Pregnant or lactating women\n* Participants who had undergone cervical surgery within 3 months\n* Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial\n* Participants who can not write informed consent\n* Participants who is difficult to participate in the trial according to investigator's decision"}, 'identificationModule': {'nctId': 'NCT04035018', 'briefTitle': 'Effectiveness of Pharmacopuncture for Chronic Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Jaseng Medical Foundation'}, 'officialTitle': 'A Study on the Effectiveness of Pharmacopuncture for Chronic Neck Pain: A Protocol for a Pragmatic Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'JS-CT-2019-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pharmacopuncture therapy', 'description': "The physicians will select one or more pharmacopuncture therapy for each participants. The physicians will also decide dosage and frequency of treatment according to the participant's status.", 'interventionNames': ['Procedure: pharmacopuncture therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'physical therapy', 'description': "The physicians will select one or more physical therapy for each participants. The physicians will also decide intensity and frequency of treatment according to the participant's status.", 'interventionNames': ['Procedure: Physical therapy']}], 'interventions': [{'name': 'pharmacopuncture therapy', 'type': 'PROCEDURE', 'description': "The participants in the treatment group will be receive one or more pharmacopuncture therapy according to the physician's decision.", 'armGroupLabels': ['pharmacopuncture therapy']}, {'name': 'Physical therapy', 'type': 'PROCEDURE', 'description': "The participants in the control group will be receive one or more physical therapy according to the physician's decision.", 'armGroupLabels': ['physical therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-896', 'city': 'Seoul', 'state': 'Gangnam-Gu', 'country': 'South Korea', 'facility': 'Jaseng Hospital of Korean Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '14598', 'city': 'Bucheon-si', 'state': 'Gyeonggi Province', 'country': 'South Korea', 'facility': 'Bucheon Jaseng Hospital of Korean Medicine', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '48102', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Haeundae Jaseng Hospital of Korean Medicine', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '35262', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Daejeon Jaseng Hospital of Korean Medicine', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}], 'overallOfficials': [{'name': 'In-Hyuk Ha', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jaseng Hospital of Korean Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaseng Medical Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'In-Hyuk Ha, KMD', 'investigatorAffiliation': 'Jaseng Medical Foundation'}}}}