Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT00925951
Status:
COMPLETED
Last Update Posted:
2010-01-05
First Post:
2009-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'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': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'lastUpdateSubmitDate': '2010-01-04', 'studyFirstSubmitDate': '2009-06-19', 'studyFirstSubmitQcDate': '2009-06-19', 'lastUpdatePostDateStruct': {'date': '2010-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Rating Scale (NRS) for pain', 'timeFrame': 'study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation'}], 'secondaryOutcomes': [{'measure': 'Present Pain Intensity Scale of the McGill Pain Questionaire (PPI)', 'timeFrame': 'study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation'}, {'measure': 'Oswestry Disability Questionnaire (ODQ)', 'timeFrame': 'study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation'}, {'measure': 'Medication Quantification Scale (MQS)', 'timeFrame': 'study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation'}, {'measure': 'General Assessment of Doctors and Subjects', 'timeFrame': 'study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation'}, {'measure': 'Safety measurement', 'timeFrame': 'study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Persistent Non-specific Low Back Pain', 'wet cupping', 'cupping', 'Numerical Rating Scale'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '21663617', 'type': 'DERIVED', 'citation': 'Kim JI, Kim TH, Lee MS, Kang JW, Kim KH, Choi JY, Kang KW, Kim AR, Shin MS, Jung SY, Choi SM. Evaluation of wet-cupping therapy for persistent non-specific low back pain: a randomised, waiting-list controlled, open-label, parallel-group pilot trial. Trials. 2011 Jun 10;12:146. doi: 10.1186/1745-6215-12-146.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that the improvement of Numeric Rating Scale (NRS) for Pain at the end of the study will be greater in the Wet Cupping Treatment group than in the Waiting Control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have had non-specific low back pains at least 12 weeks now.\n\nExclusion Criteria:\n\n* Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome).\n* Patients who are inappropriate to the wet cupping treatment.\n\n * AIDS, Active Hepatitis, Tuberculosis, Syphilis\n * Patients who regularly take anticoagulants, antiplatelet drugs\n * Anemia, thrombocytopenia\n * Hemorrhagic disease like hemophilia\n * Diabetes\n * Severe cardiovascular disease\n * Kidney diseases (renal failure, chronic renal disease)\n* Patients who have experiences of wet cupping treatment during last 3 months.\n* Patients who have had treatment for low back pain during last 2 weeks.\n* Patients who are in pregnancy or have plan to conception.\n* Patients who have vertebra surgery or have plan of surgery.\n* Patients who are inappropriate to join this trial judged by the radiologists or specialists.'}, 'identificationModule': {'nctId': 'NCT00925951', 'briefTitle': 'The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Korea Institute of Oriental Medicine'}, 'officialTitle': 'The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain: A Randomized, Waiting-list Controlled, Open-label, Parallel-group Pilot Study', 'orgStudyIdInfo': {'id': 'KI0905'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wet Cupping', 'interventionNames': ['Device: Wet Cupping', 'Drug: Acetaminophen']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting Control', 'description': "They can't use any other specific treatment except exercises and behavior modification (we'll offer a brochure which includes exercise method and directions about behavior modifications).", 'interventionNames': ['Drug: Acetaminophen']}], 'interventions': [{'name': 'Wet Cupping', 'type': 'DEVICE', 'otherNames': ['Disposable wet cupping cup, Seongho trade & company, Korea'], 'description': 'Wet cupping (Seongho trade \\& company, Korea) will be practiced at two selected points (among the 6 acupoints, left or right BL23, BL24, BL25)', 'armGroupLabels': ['Wet Cupping']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'description': 'Acetaminophen 500 mg tablets will be offered to both of the wet cupping group and waiting group for relieving severe pain.', 'armGroupLabels': ['Waiting Control', 'Wet Cupping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '302-869', 'city': 'Daejeon', 'state': 'Chungchong', 'country': 'South Korea', 'facility': 'Korea Institue of Oriental Medicine (KIOM), Doonsan Oriental Hospital of Daejeon University', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}], 'overallOfficials': [{'name': 'Sun-mi Choi, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Korea Institute of Oriental Medicine (KIOM)'}, {'name': 'Jong-In Kim, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Korea Institue of Oriental Medicine (KIOM)'}, {'name': 'Tae-hun Kim, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea Institue of Oriental Medicine (KIOM)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Institute of Oriental Medicine', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Kim Ki-ok', 'oldOrganization': 'Korea Institute of Oriental Medicine'}}}}