Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Prospective randomized controlled trials to evaluate effectiveness and efficacy between surgical vs. non-surgical treatment for optimal treatment of low back pain Prospective observational clinical study for non-surgical treatment methods Analysis of health insurance data Comprehensive symposium Provide guideline for optimal treatment of low back pain 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

Official Title
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Randomized Control Trial. Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: open or endoscopic discectomy
* Procedure: epidural block
* Other: exercise
* Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
* Procedure: decompression
* Procedure: instrumentation and fusion
* Drug: codeine, oxycontine, IRcodone, Tramadol
* Procedure: epidural adhesiolysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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) 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) 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: 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 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIVD-OP<br>open or endoscopic discectomy | Procedure: open or endoscopic discectomy<br>* FDA approved surgical procedures<br>Procedure: decompression<br>* FDA approved surgical procedure such as lamiectom and, laminotomy<br>Procedure: instrumentation and fusion<br>* FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF<br>|
| Experimental: HIVD-NonOP<br>epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol | Procedure: epidural block<br>* epidural block<br>Other: exercise<br>* educated exercise<br>Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac<br>* FDA approved medication such as ibuprofen, naxoprofen etc.<br>* Other names: NSAID;Drug: codeine, oxycontine, IRcodone, Tramadol<br>* FDA approved opioid drug such as codeine, oxycontin, IRcodon<br>* Other names: opioid;Procedure: epidural adhesiolysis<br>* FDA approved epidural adhesiolysis with catheter or endoscope<br>|
| Active Comparator: LSS w/o instability -OP<br>decompression, instrumentation and fusion | Procedure: decompression<br>* FDA approved surgical procedure such as lamiectom and, laminotomy<br>Procedure: instrumentation and fusion<br>* FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF<br>|
| Experimental: LSS w/o instability -NonOP<br>epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol | Procedure: epidural block<br>* epidural block<br>Other: exercise<br>* educated exercise<br>Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac<br>* FDA approved medication such as ibuprofen, naxoprofen etc.<br>* Other names: NSAID;Drug: codeine, oxycontine, IRcodone, Tramadol<br>* FDA approved opioid drug such as codeine, oxycontin, IRcodon<br>* Other names: opioid;Procedure: epidural adhesiolysis<br>* FDA approved epidural adhesiolysis with catheter or endoscope<br>|
| Active Comparator: LSS w/ instability - OP<br>decompression, instrumentation and fusion | Procedure: decompression<br>* FDA approved surgical procedure such as lamiectom and, laminotomy<br>Procedure: instrumentation and fusion<br>* FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF<br>|
| Experimental: LSS w/ instability - NonOP<br>epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol | Procedure: epidural block<br>* epidural block<br>Other: exercise<br>* educated exercise<br>Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac<br>* FDA approved medication such as ibuprofen, naxoprofen etc.<br>* Other names: NSAID;Drug: codeine, oxycontine, IRcodone, Tramadol<br>* FDA approved opioid drug such as codeine, oxycontin, IRcodon<br>* Other names: opioid;Procedure: epidural adhesiolysis<br>* FDA approved epidural adhesiolysis with catheter or endoscope<br>|
| Active Comparator: No intervention group<br>exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol | Other: exercise<br>* educated exercise<br>Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac<br>* FDA approved medication such as ibuprofen, naxoprofen etc.<br>* Other names: NSAID;Drug: codeine, oxycontine, IRcodone, Tramadol<br>* FDA approved opioid drug such as codeine, oxycontin, IRcodon<br>* Other names: opioid;Procedure: epidural adhesiolysis<br>* FDA approved epidural adhesiolysis with catheter or endoscope<br>|
| Experimental: Intervention group<br>epidural block, epidural adhesiolysis | Procedure: epidural block<br>* epidural block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Intervertebral Disc Degeneration, Spinal stenosis, Comparative Effectiveness Research, Cost-Benefit Analysis