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

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

• open or endoscopic discectomy (Procedure): FDA approved surgical procedures
• epidural block (Procedure): epidural block
• exercise (Other): educated exercise
• ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac (Drug), also known as NSAID: 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), also known as opioid: FDA approved opioid drug such as codeine, oxycontin, IRcodon
• epidural adhesiolysis (Procedure): FDA approved epidural adhesiolysis with catheter or endoscope

Primary outcomes

• 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 outcomes

• 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
• Cost-effectiveness [24 month after treatment]: Compare direct cost after each treatment
• 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

Sex: All, ages: 18 Years to any

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

• Chun Kee Chung, Professor, Principal investigator, Seoul National University Hospital