Low Back Pain
Conditions
Keywords
Low back pain, Intervertebral Disc Degeneration, Spinal stenosis, Comparative Effectiveness Research, Cost-Benefit Analysis
Brief summary
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
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: 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
Interventions
PROCEDUREopen or endoscopic discectomy
FDA approved surgical procedures
PROCEDUREepidural block
epidural block
OTHERexercise
educated exercise
DRUGibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
FDA approved medication such as ibuprofen, naxoprofen etc.
PROCEDUREdecompression
FDA approved surgical procedure such as lamiectom and, laminotomy
PROCEDUREinstrumentation and fusion
FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF
DRUGcodeine, oxycontine, IRcodone, Tramadol
FDA approved opioid drug such as codeine, oxycontin, IRcodon
PROCEDUREepidural adhesiolysis
FDA approved epidural adhesiolysis with catheter or endoscope
Sponsors
Seoul National University Bundang Hospital
Gangnam Severance Hospital
Severance Hospital
Korea University Guro Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 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
1. 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the change of pain score after treatment | baseline and 24 months after treatment. | Visual analog scale (VAS) is decresed more than 2.5 or VAS is less than 3.5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life index (SF-36) | 1, 3, 6, 12, 24 months after treatment. | compare the trend of change with mixed-model |
| Quality of life index (EQ-5D-5L) | 1, 3, 6, 12, 24 months after treatment. | compare the trend of change with mixed-model |
| Cost-effectiveness | 24 month after treatment | Compare direct cost after each treatment |
| Appropriate conservative treatment period | 1, 3, 6, 12, 24 months after treatment. | Appropriate conservative treatment period, Cost-effectiveness analysis (Quality of life index (SF-36, EQ-5D-5L), Direct medical cost) |
| the change of pain score (Visual anlogue pain score) after time of treatment | 1, 3, 6, 12, 24 months after treatment. | compare the trend of change with mixed-model |
Countries
South Korea
Outcome results
None listed