Randomized Control Trial. Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,102
- 试验地点
- 1
- 主要终点
- Compare the change of pain score after treatment
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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
研究组 & 干预措施
HIVD-NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: codeine, oxycontine, IRcodone, Tramadol (Drug)
HIVD-OP
open or endoscopic discectomy
干预措施: open or endoscopic discectomy (Procedure)
HIVD-OP
open or endoscopic discectomy
干预措施: decompression (Procedure)
HIVD-OP
open or endoscopic discectomy
干预措施: instrumentation and fusion (Procedure)
HIVD-NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: epidural block (Procedure)
HIVD-NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: exercise (Other)
HIVD-NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac (Drug)
HIVD-NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: epidural adhesiolysis (Procedure)
LSS w/o instability -OP
decompression, instrumentation and fusion
干预措施: decompression (Procedure)
LSS w/o instability -OP
decompression, instrumentation and fusion
干预措施: instrumentation and fusion (Procedure)
LSS w/o instability -NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: epidural block (Procedure)
LSS w/o instability -NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: exercise (Other)
LSS w/o instability -NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac (Drug)
LSS w/o instability -NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: codeine, oxycontine, IRcodone, Tramadol (Drug)
LSS w/o instability -NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: epidural adhesiolysis (Procedure)
LSS w/ instability - OP
decompression, instrumentation and fusion
干预措施: decompression (Procedure)
LSS w/ instability - OP
decompression, instrumentation and fusion
干预措施: instrumentation and fusion (Procedure)
LSS w/ instability - NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: epidural block (Procedure)
LSS w/ instability - NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: exercise (Other)
LSS w/ instability - NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac (Drug)
LSS w/ instability - NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: codeine, oxycontine, IRcodone, Tramadol (Drug)
LSS w/ instability - NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: epidural adhesiolysis (Procedure)
No intervention group
exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: exercise (Other)
No intervention group
exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac (Drug)
No intervention group
exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: codeine, oxycontine, IRcodone, Tramadol (Drug)
No intervention group
exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
干预措施: epidural adhesiolysis (Procedure)
Intervention group
epidural block, epidural adhesiolysis
干预措施: epidural block (Procedure)
结局指标
主要结局
Compare the change of pain score after treatment
时间窗: baseline and 24 months after treatment.
Visual analog scale (VAS) is decresed more than 2.5 or VAS is less than 3.5.
次要结局
- the change of pain score (Visual anlogue pain score) after time of treatment(1, 3, 6, 12, 24 months after treatment.)
- Quality of life index (SF-36)(1, 3, 6, 12, 24 months after treatment.)
- Appropriate conservative treatment period(1, 3, 6, 12, 24 months after treatment.)
- Cost-effectiveness(24 month after treatment)
- Quality of life index (EQ-5D-5L)(1, 3, 6, 12, 24 months after treatment.)
研究者
Chun Kee Chung
Professor
Seoul National University Hospital