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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| Gangnam Severance Hospital | OTHER |
| Severance Hospital | OTHER |
| Korea University Guro Hospital |
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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.
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.
Contents:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIVD-OP | Active Comparator | open or endoscopic discectomy |
|
| HIVD-NonOP | Experimental | epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol |
|
| LSS w/o instability -OP | Active Comparator | decompression, instrumentation and fusion |
|
| LSS w/o instability -NonOP | Experimental | epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol |
|
| LSS w/ instability - OP |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open or endoscopic discectomy | Procedure | FDA approved surgical procedures |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the change of pain score after treatment | Visual analog scale (VAS) is decresed more than 2.5 or VAS is less than 3.5. | baseline and 24 months after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Appropriate conservative treatment period | Appropriate conservative treatment period, Cost-effectiveness analysis (Quality of life index (SF-36, EQ-5D-5L), Direct medical cost) | 1, 3, 6, 12, 24 months after treatment. |
| the change of pain score (Visual anlogue pain score) after time of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun Kee Chung, Professor | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| OTHER |
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decompression, instrumentation and fusion |
|
| LSS w/ instability - NonOP | Experimental | epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol |
|
| No intervention group | Active Comparator | exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol |
|
| Intervention group | Experimental | epidural block, epidural adhesiolysis |
|
| epidural block |
| Procedure |
epidural block |
|
| exercise | Other | educated exercise |
|
| ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac | Drug | FDA approved medication such as ibuprofen, naxoprofen etc. |
|
|
| decompression | Procedure | FDA approved surgical procedure such as lamiectom and, laminotomy |
|
| instrumentation and fusion | Procedure | FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF |
|
| codeine, oxycontine, IRcodone, Tramadol | Drug | FDA approved opioid drug such as codeine, oxycontin, IRcodon |
|
|
| epidural adhesiolysis | Procedure | FDA approved epidural adhesiolysis with catheter or endoscope |
|
compare the trend of change with mixed-model |
| 1, 3, 6, 12, 24 months after treatment. |
| Cost-effectiveness | Compare direct cost after each treatment | 24 month after treatment |
| Quality of life index (SF-36) | compare the trend of change with mixed-model | 1, 3, 6, 12, 24 months after treatment. |
| Quality of life index (EQ-5D-5L) | compare the trend of change with mixed-model | 1, 3, 6, 12, 24 months after treatment. |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D055959 | Intervertebral Disc Degeneration |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000767 | Anesthesia, Epidural |
| D015444 | Exercise |
| D007052 | Ibuprofen |
| D052246 | Cyclooxygenase 2 Inhibitors |
| C056498 | aceclofenac |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D003664 | Decompression |
| D050939 | Gene Fusion |
| D003061 | Codeine |
| D014147 | Tramadol |
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D016861 | Cyclooxygenase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D013812 | Therapeutics |
| D011312 | Pressure |
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D002491 | Central Nervous System Agents |
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