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NCT Number: NCT02883569

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

open or endoscopic discectomy

Procedure

FDA approved surgical procedures

Epidural block

Procedure

epidural block

Exercise

Other

educated exercise

ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac

Drug

FDA approved medication such as ibuprofen, naxoprofen etc.

Other names: NSAID

Decompression

Procedure

FDA approved surgical procedure such as lamiectom and, laminotomy

instrumentation and fusion

Procedure

FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF

codeine, oxycontine, IRcodone, Tramadol

Drug

FDA approved opioid drug such as codeine, oxycontin, IRcodon

Other names: opioid

epidural adhesiolysis

Procedure

FDA approved epidural adhesiolysis with catheter or endoscope

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

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

Registry information

Official study title

Randomized Control Trial. Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain

Acronym: CES_SNS_LBP

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Aug 30, 2016
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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