Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain
NCT ID: NCT02883569
Last Updated: 2023-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1102 participants
INTERVENTIONAL
2016-09-30
2021-12-31
Brief Summary
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Detailed Description
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Contents:
1. Prospective randomized controlled trials to evaluate effectiveness and efficacy between surgical vs. non-surgical treatment for optimal treatment of low back pain
2. Prospective observational clinical study for non-surgical treatment methods
3. Analysis of health insurance data
4. Comprehensive symposium
5. Provide guideline for optimal treatment of low back pain
6. 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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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HIVD-OP
open or endoscopic discectomy
open or endoscopic discectomy
FDA approved surgical procedures
decompression
FDA approved surgical procedure such as lamiectom and, laminotomy
instrumentation and fusion
FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF
HIVD-NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
epidural block
epidural block
exercise
educated exercise
ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
FDA approved medication such as ibuprofen, naxoprofen etc.
codeine, oxycontine, IRcodone, Tramadol
FDA approved opioid drug such as codeine, oxycontin, IRcodon
epidural adhesiolysis
FDA approved epidural adhesiolysis with catheter or endoscope
LSS w/o instability -OP
decompression, instrumentation and fusion
decompression
FDA approved surgical procedure such as lamiectom and, laminotomy
instrumentation and fusion
FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF
LSS w/o instability -NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
epidural block
epidural block
exercise
educated exercise
ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
FDA approved medication such as ibuprofen, naxoprofen etc.
codeine, oxycontine, IRcodone, Tramadol
FDA approved opioid drug such as codeine, oxycontin, IRcodon
epidural adhesiolysis
FDA approved epidural adhesiolysis with catheter or endoscope
LSS w/ instability - OP
decompression, instrumentation and fusion
decompression
FDA approved surgical procedure such as lamiectom and, laminotomy
instrumentation and fusion
FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF
LSS w/ instability - NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
epidural block
epidural block
exercise
educated exercise
ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
FDA approved medication such as ibuprofen, naxoprofen etc.
codeine, oxycontine, IRcodone, Tramadol
FDA approved opioid drug such as codeine, oxycontin, IRcodon
epidural adhesiolysis
FDA approved epidural adhesiolysis with catheter or endoscope
No intervention group
exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
exercise
educated exercise
ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
FDA approved medication such as ibuprofen, naxoprofen etc.
codeine, oxycontine, IRcodone, Tramadol
FDA approved opioid drug such as codeine, oxycontin, IRcodon
epidural adhesiolysis
FDA approved epidural adhesiolysis with catheter or endoscope
Intervention group
epidural block, epidural adhesiolysis
epidural block
epidural block
Interventions
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open or endoscopic discectomy
FDA approved surgical procedures
epidural block
epidural block
exercise
educated exercise
ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
FDA approved medication such as ibuprofen, naxoprofen etc.
decompression
FDA approved surgical procedure such as lamiectom and, laminotomy
instrumentation and fusion
FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF
codeine, oxycontine, IRcodone, Tramadol
FDA approved opioid drug such as codeine, oxycontin, IRcodon
epidural adhesiolysis
FDA approved epidural adhesiolysis with catheter or endoscope
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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)
3. 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)
4. 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;
Exclusion Criteria
2. 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
3. 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
4. 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
18 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Gangnam Severance Hospital
OTHER
Severance Hospital
OTHER
Korea University Guro Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Chun Kee Chung
Professor
Principal Investigators
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Chun Kee Chung, Professor
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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LBP
Identifier Type: -
Identifier Source: org_study_id
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