Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-04-16 @ 3:57 AM
Study NCT ID:
NCT01989403
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2013-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alternative and Integrative Therapy for Lumbar Disk Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012585', 'term': 'Sciatica'}, {'id': 'C535531', 'term': 'Intervertebral disc disease'}], 'ancestors': [{'id': 'D020426', 'term': 'Sciatic Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'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': 128}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2013-11-14', 'lastUpdatePostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale for low back and leg pain', 'timeFrame': 'Changes from Baseline in Visual analogue scale at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.'}, {'measure': 'the Oswestry Disability Index', 'timeFrame': 'Changes from Baseline in the Oswestry Disability Index at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.'}, {'measure': 'the SF-36 Health Survey', 'timeFrame': 'Changes from Baseline in the SF-36 Health Survey at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.'}], 'secondaryOutcomes': [{'measure': 'Straight Leg Raise test', 'timeFrame': 'Changes from Baseline in the Straight Leg Raise test at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.'}, {'measure': 'Adverse events', 'timeFrame': 'at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.', 'description': 'Skin and general reactions, aggravation or change in pain before and after acupuncture, pharmacoacupuncture, and Chuna manipulation treatment were observed.\n\nRegular blood tests (blood cell count, liver, renal function tests, inflammatory activity indexes) were administered.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sciatica', 'Intervertebral Disc Disorder']}, 'descriptionModule': {'briefSummary': 'The investigators report management of lumbar disc herniation with severe sciatic pain using an integrative complementary and alternative medicine approach with a 5 year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'integrative hospital that offers both Western and traditional Korean medical services', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LBP with sciatica,\n* A numeral rating scale (NRS) leg pain intensity of 5 or higher\n* Onset within 1 year;\n* Lumbar Disk Heriation confirmed by MRI;\n* Written consent to attend 6 months of integrative CAM treatment and following assessment visits.\n\nExclusion Criteria:\n\n* Treatment regarding the current LBP and/or sciatica (e.g. surgery, nerve block, or analgesic medication) other than the CAM treatment specified in the protocol\n* Non-spinal or soft tissue problem related to back pain or sciatica (e.g. pregnancy, spinal tumor, or rheumatoid arthritis)\n* History of spinal surgery, vertebral dislocation, fracture, or cancer;'}, 'identificationModule': {'nctId': 'NCT01989403', 'briefTitle': 'Alternative and Integrative Therapy for Lumbar Disk Herniation', 'organization': {'class': 'OTHER', 'fullName': 'Jaseng Hospital of Korean Medicine'}, 'officialTitle': 'The Long-term Course of Patients Undergoing Alternative and Integrative Therapy for Lumbar Disk Herniation: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'JS-CT-2011-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lumbar disc herniation patients', 'description': 'LBP with sciatica, with a numeral rating scale (NRS) leg pain intensity of 5 or higher and onset within 1 year; (2) LDH confirmed by MRI', 'interventionNames': ['Other: herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation']}], 'interventions': [{'name': 'herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation', 'type': 'OTHER', 'armGroupLabels': ['Lumbar disc herniation patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-896', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Jaseng Spine and joint Research Institute', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaseng Hospital of Korean Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}