Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT01791933
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2013-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of the Effectiveness of CAM Treatments for Lumbar and Cervical Spine Pain Patients Due to Spinal Disease
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': 'D008517', 'term': 'Phytotherapy'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2013-02-07', 'studyFirstSubmitQcDate': '2013-02-12', 'lastUpdatePostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NRS of low back pain or neck pain/NRS of radiating pain', 'timeFrame': 'Change from Baseline at 3rd month'}], 'secondaryOutcomes': [{'measure': 'ODI (Oswestry Disability Index)', 'timeFrame': 'Baseline, 1st month, 2nd month, 3rd month'}, {'measure': 'Patient satisfaction', 'timeFrame': '3rd month', 'description': 'Patient satisfaction of treatment'}, {'measure': 'Job loss', 'timeFrame': 'Baseline, 1st month, 2nd month, 3rd month', 'description': 'Life activity of loss rate'}, {'measure': 'painkiller intaken of times', 'timeFrame': 'Baseline, 3rd month'}, {'measure': 'Adverse reactions', 'timeFrame': 'Baseline, 1st month, 2nd month, 3rd month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['LBP', 'Neck pain', 'Integrative package', 'CAM'], 'conditions': ['Lumbar and Cervical Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of CAM treatments consisting of herbal medicine, Chuna manual therapy, pharmacoacupuncture, acupuncture on lumbar and cervical spine pain patients due to spinal disease.', 'detailedDescription': '"The purpose of this study is to investigate the effect of CAM treatments on lumbar and cervical spine pain patients due to spinal disease.\n\nAfter subjects selected by screening, who receive CAM treatments 1-2times a week for more than 2 months and F/U at 1st, 2nd, 3rd month by meeting and F/U at 6nd, 12nd month by calling.\n\nThe CAM treatments used in this study consists of 120ml of Chuna herbal medicine(Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, and Cuscuta chinensis) and dried extracts in pill form(Cibotium barometz, Atractylodes japonica) taken twice a day 30 minutes after meals, Chuna manual therapy, intermuscular injections of bee-venom pharmacoacupuncture(Select 6 acupoints, concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session), acupuncture and allow for NSAID intake during the investigational period. The subject is allowed a maximum of 3 pills/day, taken at a minimum of 8 hrs apart. The number of pills taken will be measured at 4 wks after conclusion of treatment."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patient sampling within lumbar and cervical spine pain patients due to spinal disease.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients suffering from low back pain or Neck due to spinal disease Agree to the treatment of more than 2 months\n* Age all(If under 18yr, Guardian's consent need)\n* Volunteers do not have a problem with my speech as those who have signed the consent\n\nExclusion Criteria:\n\n* Diagnosis of serious disease(s) which are possible causes of back pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equina compression, etc.\n* Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.\n* Progressive neurologic deficit(s) or concurrent severe neurological symptoms Unsuitable for or at risk of complications from acupuncture treatment such as patients with clotting disorders, severe diabetes with risk of infection, serious cardiovascular disease, or undergoing anticoagulant treatment, etc.\n* Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine, or other medication considered unsuitable for subjects by the researcher\n* Experience of gastroenteric complications after taking NSAIDs or currently undergoing treatment for digestive disorders\n* During pregnancy or suspected pregnancy\n* Subjects considered unsuitable for clinical trial by the researcher"}, 'identificationModule': {'nctId': 'NCT01791933', 'briefTitle': 'The Evaluation of the Effectiveness of CAM Treatments for Lumbar and Cervical Spine Pain Patients Due to Spinal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Jaseng Hospital of Korean Medicine'}, 'officialTitle': 'The Evaluation of the Effectiveness of CAM Treatments for Lumbar and Cervical Spine Pain Patients Due to Spinal Disease : Prospective, Observational Study', 'orgStudyIdInfo': {'id': 'JS-CT-2013-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CAM treatment', 'interventionNames': ['Drug: herbal medicine', 'Procedure: Chuna manual therapy', 'Procedure: Acupuncture', 'Procedure: Bee-venom pharmacoacupuncture/pharmacoacupuncture']}], 'interventions': [{'name': 'herbal medicine', 'type': 'DRUG', 'description': '120ml of Chuna herbal medicine(Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, and Cuscuta chinensis) taken twice a day 30 minutes after meals for more than 2 months', 'armGroupLabels': ['CAM treatment']}, {'name': 'Chuna manual therapy', 'type': 'PROCEDURE', 'otherNames': ['Chuna manipulation'], 'description': "A type of Korean spinal manual therapy administered 5\\~10 minutes at physician's discretion 1-2times a week for more than 2 months Applies mobilization using High-Velocity, Low-Amplitude thrusts to joints slightly beyond the passive ROM and manual force within the passive ROM without thrusts.", 'armGroupLabels': ['CAM treatment']}, {'name': 'Acupuncture', 'type': 'PROCEDURE', 'description': "Acupuncture using sterilized disposable needles, sized 0.30X40mm. Needles left for 15\\~20 minutes, selecting 6 acupoints(both BL23, BL24, BL25 ) and other acupoints at physician's discretion, using a total of 10\\~20 acupoints 1-2times a week for more than 2 months", 'armGroupLabels': ['CAM treatment']}, {'name': 'Bee-venom pharmacoacupuncture/pharmacoacupuncture', 'type': 'PROCEDURE', 'otherNames': ['BV', 'Bee-venom therapy'], 'description': "pharmacoacupuncture using 30G sterilized bee venom. Selecting 6 acupoints(both BL23, BL24, BL25) and other acupoints at physician's discretion, concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session 1-2times a week for more than 2 months", 'armGroupLabels': ['CAM treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Gangnam-gu', 'country': 'South Korea', 'facility': 'Jaseng Hospital of Oriental Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jinho LEE, KMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jaseng Hospital of Korean Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaseng Hospital of Korean Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}