Randomized Control Trial. Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain
Overview
- Phase
- Not Applicable
- Intervention
- codeine, oxycontine, IRcodone, Tramadol
- Conditions
- Low Back Pain
- Sponsor
- Seoul National University Hospital
- Enrollment
- 1102
- Locations
- 1
- Primary Endpoint
- Compare the change of pain score after treatment
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Chun Kee Chung
Professor
Seoul National University Hospital
Eligibility Criteria
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
Arms & Interventions
HIVD-NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: codeine, oxycontine, IRcodone, Tramadol
HIVD-OP
open or endoscopic discectomy
Intervention: open or endoscopic discectomy
HIVD-OP
open or endoscopic discectomy
Intervention: decompression
HIVD-OP
open or endoscopic discectomy
Intervention: instrumentation and fusion
HIVD-NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: epidural block
HIVD-NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: exercise
HIVD-NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
HIVD-NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: epidural adhesiolysis
LSS w/o instability -OP
decompression, instrumentation and fusion
Intervention: decompression
LSS w/o instability -OP
decompression, instrumentation and fusion
Intervention: instrumentation and fusion
LSS w/o instability -NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: epidural block
LSS w/o instability -NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: exercise
LSS w/o instability -NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
LSS w/o instability -NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: codeine, oxycontine, IRcodone, Tramadol
LSS w/o instability -NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: epidural adhesiolysis
LSS w/ instability - OP
decompression, instrumentation and fusion
Intervention: decompression
LSS w/ instability - OP
decompression, instrumentation and fusion
Intervention: instrumentation and fusion
LSS w/ instability - NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: epidural block
LSS w/ instability - NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: exercise
LSS w/ instability - NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
LSS w/ instability - NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: codeine, oxycontine, IRcodone, Tramadol
LSS w/ instability - NonOP
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: epidural adhesiolysis
No intervention group
exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: exercise
No intervention group
exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
No intervention group
exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: codeine, oxycontine, IRcodone, Tramadol
No intervention group
exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention: epidural adhesiolysis
Intervention group
epidural block, epidural adhesiolysis
Intervention: epidural block
Outcomes
Primary Outcomes
Compare the change of pain score after treatment
Time Frame: 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
- 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.)