Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT02883569
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2016-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D013130', 'term': 'Spinal Stenosis'}], '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'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000767', 'term': 'Anesthesia, Epidural'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D052246', 'term': 'Cyclooxygenase 2 Inhibitors'}, {'id': 'C056498', 'term': 'aceclofenac'}, {'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}, {'id': 'D003664', 'term': 'Decompression'}, {'id': 'D050939', 'term': 'Gene Fusion'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D014147', 'term': 'Tramadol'}, {'id': 'D000701', 'term': 'Analgesics, Opioid'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D016861', 'term': 'Cyclooxygenase Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011312', 'term': 'Pressure'}, {'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011995', 'term': 'Recombination, Genetic'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D009294', 'term': 'Narcotics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2016-07-25', 'studyFirstSubmitQcDate': '2016-08-24', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the change of pain score after treatment', 'timeFrame': 'baseline and 24 months after treatment.', 'description': 'Visual analog scale (VAS) is decresed more than 2.5 or VAS is less than 3.5.'}], 'secondaryOutcomes': [{'measure': 'Appropriate conservative treatment period', 'timeFrame': '1, 3, 6, 12, 24 months after treatment.', 'description': 'Appropriate conservative treatment period, Cost-effectiveness analysis (Quality of life index (SF-36, EQ-5D-5L), Direct medical cost)'}, {'measure': 'the change of pain score (Visual anlogue pain score) after time of treatment', 'timeFrame': '1, 3, 6, 12, 24 months after treatment.', 'description': 'compare the trend of change with mixed-model'}, {'measure': 'Cost-effectiveness', 'timeFrame': '24 month after treatment', 'description': 'Compare direct cost after each treatment'}, {'measure': 'Quality of life index (SF-36)', 'timeFrame': '1, 3, 6, 12, 24 months after treatment.', 'description': 'compare the trend of change with mixed-model'}, {'measure': 'Quality of life index (EQ-5D-5L)', 'timeFrame': '1, 3, 6, 12, 24 months after treatment.', 'description': 'compare the trend of change with mixed-model'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Low back pain', 'Intervertebral Disc Degeneration', 'Spinal stenosis', 'Comparative Effectiveness Research', 'Cost-Benefit Analysis'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Purpose: Comparative effectiveness research (CER) between surgical and non-surgical treatment for patients with low back pain Hypothesis: There will be significant differences in surgical and non-surgical treatment effect in patients who need operation for herniated intervertebral disc and spinal stenosis.', 'detailedDescription': 'Background: Eighty percents of the total population experiences lower back pain (LBP). Prevalence of LBP is about 20 to 30%. LBP is the most frequent disease and causes a lot of the medical and social costs. Recently the traditional drug therapy, exercise therapy has been developed and various non-surgical treatments have been developed. Surgical techniques are also rapidly evolving. In Korea lumbar spine surgeries were performed in accordance with the national practice guidelines presented by the Health Insurance Review and Assessment Service. Many patients who do not meet the surgical criteria undergo the non-surgical treatment, but there is no reliable research data for a systematic and cost-effective results of non-surgical treatment. It will be a big part of the future medical expenses because there is no guideline for the expensive procedure.\n\nContents:\n\n1. Prospective randomized controlled trials to evaluate effectiveness and efficacy between surgical vs. non-surgical treatment for optimal treatment of low back pain\n2. Prospective observational clinical study for non-surgical treatment methods\n3. Analysis of health insurance data\n4. Comprehensive symposium\n5. Provide guideline for optimal treatment of low back pain\n6. The results will be used to reflect National health insurance policy Development Results: Suggestion of guideline for optimal treatment of low back pain through analysis of efficacy and effectiveness between treatments'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Herniated intervertebral disease, Low back pain over 6 weeks: if neurological deficit is combined early surgery is allowed; Over 18 years; Visual analogue pain score over 5; Compatible findings in MRI and/or CT\n2. Lumbar spinal stenosis without instability, Low back pain over 3 months: if neurological deficit is combined early surgery is allowed; Over 18 years; Visual analogue pain score over 5; Compatible findings in MRI and/or CT; Without instability (15 degrees and 4mm motion)\n3. Lumbar spinal stenosis with instability, Low back pain over 3 months: if neurological deficit is combined early surgery is allowed; Over 18 years; Visual analogue pain score over 5; Compatible findings in MRI and/or CT; With instability (15 degrees and 4mm motion)\n4. No surgical indication, Low back pain over 6 weeks: if neurological deficit is combined early surgery is allowed; Over 18 years; Visual analogue pain score over 5; Compatible findings in MRI and/or CT;\n\nExclusion Criteria:\n\n1. Herniated intervertebral disease, Cauda equine syndrome; Instability (15degrees, 4mm motion); Fracture, pregnancy; Any comorbidities that preclude operation; Combined disease: Neuromuscular disease, parkinson's disease, inflammatory arthritis, symptomatic spinal tumor, myelopathy, spinal infection; Previous lumbar spinal surgery; Neurological deficit that necessitates surgery\n2. Lumbar spinal stenosis without instability, Cauda equine syndrome; Instability (15degrees, 4mm motion); Fracture, pregnancy Any comorbidities that preclude operation; Combined disease: Neuromuscular disease, parkinson's disease, inflammatory arthritis, symptomatic spinal tumor, myelopathy, spinal infection; Previous lumbar spinal surgery; Neurological deficit that necessitates surgery\n3. Lumbar spinal stenosis with instability, Cauda equine syndrome; Fracture, pregnancy; Any comorbidities that preclude operation; Combined disease: Neuromuscular disease, parkinson's disease, inflammatory arthritis, symptomatic spinal tumor, myelopathy, spinal infection Previous lumbar spinal surgery; Neurological deficit that necessitates surgery\n4. No surgical indication, Cauda equine syndrome; Fracture, pregnancy; Combined disease: Neuromuscular disease, parkinson's disease, inflammatory arthritis, symptomatic spinal tumor, myelopathy, spinal infection; Neurological deficit that necessitates surgery"}, 'identificationModule': {'nctId': 'NCT02883569', 'acronym': 'CES_SNS_LBP', 'briefTitle': 'Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Randomized Control Trial. Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain', 'orgStudyIdInfo': {'id': 'LBP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HIVD-OP', 'description': 'open or endoscopic discectomy', 'interventionNames': ['Procedure: open or endoscopic discectomy', 'Procedure: decompression', 'Procedure: instrumentation and fusion']}, {'type': 'EXPERIMENTAL', 'label': 'HIVD-NonOP', 'description': 'epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol', 'interventionNames': ['Procedure: epidural block', 'Other: exercise', 'Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac', 'Drug: codeine, oxycontine, IRcodone, Tramadol', 'Procedure: epidural adhesiolysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LSS w/o instability -OP', 'description': 'decompression, instrumentation and fusion', 'interventionNames': ['Procedure: decompression', 'Procedure: instrumentation and fusion']}, {'type': 'EXPERIMENTAL', 'label': 'LSS w/o instability -NonOP', 'description': 'epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol', 'interventionNames': ['Procedure: epidural block', 'Other: exercise', 'Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac', 'Drug: codeine, oxycontine, IRcodone, Tramadol', 'Procedure: epidural adhesiolysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LSS w/ instability - OP', 'description': 'decompression, instrumentation and fusion', 'interventionNames': ['Procedure: decompression', 'Procedure: instrumentation and fusion']}, {'type': 'EXPERIMENTAL', 'label': 'LSS w/ instability - NonOP', 'description': 'epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol', 'interventionNames': ['Procedure: epidural block', 'Other: exercise', 'Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac', 'Drug: codeine, oxycontine, IRcodone, Tramadol', 'Procedure: epidural adhesiolysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No intervention group', 'description': 'exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol', 'interventionNames': ['Other: exercise', 'Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac', 'Drug: codeine, oxycontine, IRcodone, Tramadol', 'Procedure: epidural adhesiolysis']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'epidural block, epidural adhesiolysis', 'interventionNames': ['Procedure: epidural block']}], 'interventions': [{'name': 'open or endoscopic discectomy', 'type': 'PROCEDURE', 'description': 'FDA approved surgical procedures', 'armGroupLabels': ['HIVD-OP']}, {'name': 'epidural block', 'type': 'PROCEDURE', 'description': 'epidural block', 'armGroupLabels': ['HIVD-NonOP', 'Intervention group', 'LSS w/ instability - NonOP', 'LSS w/o instability -NonOP']}, {'name': 'exercise', 'type': 'OTHER', 'description': 'educated exercise', 'armGroupLabels': ['HIVD-NonOP', 'LSS w/ instability - NonOP', 'LSS w/o instability -NonOP', 'No intervention group']}, {'name': 'ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac', 'type': 'DRUG', 'otherNames': ['NSAID'], 'description': 'FDA approved medication such as ibuprofen, naxoprofen etc.', 'armGroupLabels': ['HIVD-NonOP', 'LSS w/ instability - NonOP', 'LSS w/o instability -NonOP', 'No intervention group']}, {'name': 'decompression', 'type': 'PROCEDURE', 'description': 'FDA approved surgical procedure such as lamiectom and, laminotomy', 'armGroupLabels': ['HIVD-OP', 'LSS w/ instability - OP', 'LSS w/o instability -OP']}, {'name': 'instrumentation and fusion', 'type': 'PROCEDURE', 'description': 'FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF', 'armGroupLabels': ['HIVD-OP', 'LSS w/ instability - OP', 'LSS w/o instability -OP']}, {'name': 'codeine, oxycontine, IRcodone, Tramadol', 'type': 'DRUG', 'otherNames': ['opioid'], 'description': 'FDA approved opioid drug such as codeine, oxycontin, IRcodon', 'armGroupLabels': ['HIVD-NonOP', 'LSS w/ instability - NonOP', 'LSS w/o instability -NonOP', 'No intervention group']}, {'name': 'epidural adhesiolysis', 'type': 'PROCEDURE', 'description': 'FDA approved epidural adhesiolysis with catheter or endoscope', 'armGroupLabels': ['HIVD-NonOP', 'LSS w/ instability - NonOP', 'LSS w/o instability -NonOP', 'No intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chun Kee Chung, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chun Kee Chung', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}