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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02883569
Collaborator
Seoul National University Bundang Hospital (Other), Gangnam Severance Hospital (Other), Severance Hospital (Other), Korea University Guro Hospital (Other)
1,102
1
8
63
17.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: open or endoscopic discectomy
  • Procedure: epidural block
  • Other: exercise
  • Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
  • Procedure: decompression
  • Procedure: instrumentation and fusion
  • Drug: codeine, oxycontine, IRcodone, Tramadol
  • Procedure: epidural adhesiolysis
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1102 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Control Trial. Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain
Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: HIVD-OP

open or endoscopic discectomy

Procedure: open or endoscopic discectomy
FDA approved surgical procedures

Procedure: decompression
FDA approved surgical procedure such as lamiectom and, laminotomy

Procedure: instrumentation and fusion
FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF

Experimental: HIVD-NonOP

epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol

Procedure: epidural block
epidural block

Other: exercise
educated exercise

Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
FDA approved medication such as ibuprofen, naxoprofen etc.
Other Names:
  • NSAID
  • Drug: codeine, oxycontine, IRcodone, Tramadol
    FDA approved opioid drug such as codeine, oxycontin, IRcodon
    Other Names:
  • opioid
  • Procedure: epidural adhesiolysis
    FDA approved epidural adhesiolysis with catheter or endoscope

    Active Comparator: LSS w/o instability -OP

    decompression, instrumentation and fusion

    Procedure: decompression
    FDA approved surgical procedure such as lamiectom and, laminotomy

    Procedure: instrumentation and fusion
    FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF

    Experimental: LSS w/o instability -NonOP

    epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol

    Procedure: epidural block
    epidural block

    Other: exercise
    educated exercise

    Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
    FDA approved medication such as ibuprofen, naxoprofen etc.
    Other Names:
  • NSAID
  • Drug: codeine, oxycontine, IRcodone, Tramadol
    FDA approved opioid drug such as codeine, oxycontin, IRcodon
    Other Names:
  • opioid
  • Procedure: epidural adhesiolysis
    FDA approved epidural adhesiolysis with catheter or endoscope

    Active Comparator: LSS w/ instability - OP

    decompression, instrumentation and fusion

    Procedure: decompression
    FDA approved surgical procedure such as lamiectom and, laminotomy

    Procedure: instrumentation and fusion
    FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF

    Experimental: LSS w/ instability - NonOP

    epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol

    Procedure: epidural block
    epidural block

    Other: exercise
    educated exercise

    Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
    FDA approved medication such as ibuprofen, naxoprofen etc.
    Other Names:
  • NSAID
  • Drug: codeine, oxycontine, IRcodone, Tramadol
    FDA approved opioid drug such as codeine, oxycontin, IRcodon
    Other Names:
  • opioid
  • Procedure: epidural adhesiolysis
    FDA approved epidural adhesiolysis with catheter or endoscope

    Active Comparator: No intervention group

    exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol

    Other: exercise
    educated exercise

    Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac
    FDA approved medication such as ibuprofen, naxoprofen etc.
    Other Names:
  • NSAID
  • Drug: codeine, oxycontine, IRcodone, Tramadol
    FDA approved opioid drug such as codeine, oxycontin, IRcodon
    Other Names:
  • opioid
  • Procedure: epidural adhesiolysis
    FDA approved epidural adhesiolysis with catheter or endoscope

    Experimental: Intervention group

    epidural block, epidural adhesiolysis

    Procedure: epidural block
    epidural block

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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)

    2. 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

    3. Cost-effectiveness [24 month after treatment]

      Compare direct cost after each treatment

    4. Quality of life index (SF-36) [1, 3, 6, 12, 24 months after treatment.]

      compare the trend of change with mixed-model

    5. Quality of life index (EQ-5D-5L) [1, 3, 6, 12, 24 months after treatment.]

      compare the trend of change with mixed-model

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital
    • Seoul National University Bundang Hospital
    • Gangnam Severance Hospital
    • Severance Hospital
    • Korea University Guro Hospital

    Investigators

    • Principal Investigator: Chun Kee Chung, Professor, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chun Kee Chung, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02883569
    Other Study ID Numbers:
    • LBP
    First Posted:
    Aug 30, 2016
    Last Update Posted:
    Aug 27, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Chun Kee Chung, Professor, Seoul National University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 27, 2020