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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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ClinicalTrials.gov Identifier: NCT02883569
Recruitment Status : Recruiting
First Posted : August 30, 2016
Last Update Posted : February 6, 2018
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
Gangnam Severance Hospital
Severance Hospital
Korea University Guro Hospital
Information provided by (Responsible Party):
Chun Kee Chung, Seoul National University Hospital

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
Low Back Pain 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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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 Name: NSAID

Drug: codeine, oxycontine, IRcodone, Tramadol
FDA approved opioid drug such as codeine, oxycontin, IRcodon
Other Name: 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 Name: NSAID

Drug: codeine, oxycontine, IRcodone, Tramadol
FDA approved opioid drug such as codeine, oxycontin, IRcodon
Other Name: 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 Name: NSAID

Drug: codeine, oxycontine, IRcodone, Tramadol
FDA approved opioid drug such as codeine, oxycontin, IRcodon
Other Name: 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 Name: NSAID

Drug: codeine, oxycontine, IRcodone, Tramadol
FDA approved opioid drug such as codeine, oxycontin, IRcodon
Other Name: opioid

Procedure: epidural adhesiolysis
FDA approved epidural adhesiolysis with catheter or endoscope

Experimental: Intervention group
epidural block, epidural adhesiolysis
Procedure: epidural block
epidural block




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Appropriate conservative treatment period [ Time Frame: 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 [ Time Frame: 1, 3, 6, 12, 24 months after treatment. ]
    compare the trend of change with mixed-model

  3. Cost-effectiveness [ Time Frame: 24 month after treatment ]
    Compare direct cost after each treatment

  4. Quality of life index (SF-36) [ Time Frame: 1, 3, 6, 12, 24 months after treatment. ]
    compare the trend of change with mixed-model

  5. Quality of life index (EQ-5D-5L) [ Time Frame: 1, 3, 6, 12, 24 months after treatment. ]
    compare the trend of change with mixed-model



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883569


Contacts
Contact: Chun Kee Chung, Professor +82-2-2072-2352 chungc@snu.ac.kr
Contact: Chi Heon Kim, Ass prof. +82-2-2072-3398 chiheon1@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Chi Heon Kim, MD, PhD    +82-2-2072-2358    chiheon1@snu.ac.kr   
Principal Investigator: Chun Kee Chung, MD, PhD         
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

Responsible Party: Chun Kee Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02883569     History of Changes
Other Study ID Numbers: LBP
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chun Kee Chung, Seoul National University Hospital:
Low back pain
Intervertebral Disc Degeneration
Spinal stenosis
Comparative Effectiveness Research
Cost-Benefit Analysis

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ibuprofen
Aceclofenac
Tramadol
Codeine
Cyclooxygenase 2 Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents