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

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Seoul National University

Status

Completed

Conditions

Low Back Pain

Treatments

Procedure: decompression
Procedure: open or endoscopic discectomy
Procedure: epidural adhesiolysis
Drug: codeine, oxycontine, IRcodone, Tramadol
Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
Procedure: instrumentation and fusion
Other: exercise
Procedure: epidural block

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

1,102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

1,102 participants in 8 patient groups

HIVD-OP
Active Comparator group
Description:
open or endoscopic discectomy
Treatment:
Procedure: decompression
Procedure: instrumentation and fusion
Procedure: open or endoscopic discectomy
HIVD-NonOP
Experimental group
Description:
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Treatment:
Procedure: epidural block
Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
Drug: codeine, oxycontine, IRcodone, Tramadol
Procedure: epidural adhesiolysis
Other: exercise
LSS w/o instability -OP
Active Comparator group
Description:
decompression, instrumentation and fusion
Treatment:
Procedure: decompression
Procedure: instrumentation and fusion
LSS w/o instability -NonOP
Experimental group
Description:
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Treatment:
Procedure: epidural block
Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
Drug: codeine, oxycontine, IRcodone, Tramadol
Procedure: epidural adhesiolysis
Other: exercise
LSS w/ instability - OP
Active Comparator group
Description:
decompression, instrumentation and fusion
Treatment:
Procedure: decompression
Procedure: instrumentation and fusion
LSS w/ instability - NonOP
Experimental group
Description:
epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Treatment:
Procedure: epidural block
Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
Drug: codeine, oxycontine, IRcodone, Tramadol
Procedure: epidural adhesiolysis
Other: exercise
No intervention group
Active Comparator group
Description:
exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Treatment:
Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
Drug: codeine, oxycontine, IRcodone, Tramadol
Procedure: epidural adhesiolysis
Other: exercise
Intervention group
Experimental group
Description:
epidural block, epidural adhesiolysis
Treatment:
Procedure: epidural block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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