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: 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,102
FDA approved surgical procedures
epidural block
educated exercise
Seoul National University Hospital
Seoul, South Korea
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.
Time frame: baseline and 24 months after treatment.
Appropriate conservative treatment period
Appropriate conservative treatment period, Cost-effectiveness analysis (Quality of life index (SF-36, EQ-5D-5L), Direct medical cost)
Time frame: 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
Time frame: 1, 3, 6, 12, 24 months after treatment.
Cost-effectiveness
Compare direct cost after each treatment
Time frame: 24 month after treatment
Quality of life index (SF-36)
compare the trend of change with mixed-model
Time frame: 1, 3, 6, 12, 24 months after treatment.
Quality of life index (EQ-5D-5L)
compare the trend of change with mixed-model
Time frame: 1, 3, 6, 12, 24 months after treatment.
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FDA approved medication such as ibuprofen, naxoprofen etc.
FDA approved surgical procedure such as lamiectom and, laminotomy
FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF
FDA approved opioid drug such as codeine, oxycontin, IRcodon
FDA approved epidural adhesiolysis with catheter or endoscope