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

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

open or endoscopic discectomy

epidural block

exercise

ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac

decompression

instrumentation and fusion

codeine, oxycontine, IRcodone, Tramadol

epidural adhesiolysis

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Intervertebral Disc Degeneration, Spinal stenosis, Comparative Effectiveness Research, Cost-Benefit Analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

HIVD-OP

HIVD-NonOP

LSS w/o instability -OP

LSS w/o instability -NonOP

LSS w/ instability - OP

LSS w/ instability - NonOP

No intervention group

Intervention group

Arm Description

open or endoscopic discectomy

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

decompression, instrumentation and fusion

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

decompression, instrumentation and fusion

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

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

epidural block, epidural adhesiolysis

Outcomes

Primary Outcome Measures

Compare the change of pain score after treatment

Visual analog scale (VAS) is decresed more than 2.5 or VAS is less than 3.5.

Secondary Outcome Measures

Appropriate conservative treatment period

Appropriate conservative treatment period, Cost-effectiveness analysis (Quality of life index (SF-36, EQ-5D-5L), Direct medical cost)

the change of pain score (Visual anlogue pain score) after time of treatment

compare the trend of change with mixed-model

Cost-effectiveness

Compare direct cost after each treatment

Quality of life index (SF-36)

compare the trend of change with mixed-model

Quality of life index (EQ-5D-5L)

compare the trend of change with mixed-model

Full Information

NCT ID

NCT02883569

First Posted

July 25, 2016

Last Updated

April 10, 2023

Sponsor

Seoul National University Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02883569

Brief Title

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

Acronym

CES_SNS_LBP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

September 2016 (undefined)

Primary Completion Date

December 2020 (Actual)

Study Completion Date

December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Low back pain, Intervertebral Disc Degeneration, Spinal stenosis, Comparative Effectiveness Research, Cost-Benefit Analysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HIVD-OP

Arm Type

Active Comparator

Arm Description

open or endoscopic discectomy

Arm Title

HIVD-NonOP

Arm Type

Experimental

Arm Description

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

Arm Title

LSS w/o instability -OP

Arm Type

Active Comparator

Arm Description

decompression, instrumentation and fusion

Arm Title

LSS w/o instability -NonOP

Arm Type

Experimental

Arm Description

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

Arm Title

LSS w/ instability - OP

Arm Type

Active Comparator

Arm Description

decompression, instrumentation and fusion

Arm Title

LSS w/ instability - NonOP

Arm Type

Experimental

Arm Description

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

Arm Title

No intervention group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

epidural block, epidural adhesiolysis

Intervention Type

Procedure

Intervention Name(s)

open or endoscopic discectomy

Intervention Description

FDA approved surgical procedures

Intervention Type

Procedure

Intervention Name(s)

epidural block

Intervention Description

epidural block

Intervention Type

Other

Intervention Name(s)

exercise

Intervention Description

educated exercise

Intervention Type

Drug

Intervention Name(s)

ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac

Other Intervention Name(s)

NSAID

Intervention Description

FDA approved medication such as ibuprofen, naxoprofen etc.

Intervention Type

Procedure

Intervention Name(s)

decompression

Intervention Description

FDA approved surgical procedure such as lamiectom and, laminotomy

Intervention Type

Procedure

Intervention Name(s)

instrumentation and fusion

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

codeine, oxycontine, IRcodone, Tramadol

Other Intervention Name(s)

opioid

Intervention Description

FDA approved opioid drug such as codeine, oxycontin, IRcodon

Intervention Type

Procedure

Intervention Name(s)

epidural adhesiolysis

Intervention Description

FDA approved epidural adhesiolysis with catheter or endoscope

Primary Outcome Measure Information:

Title

Compare the change of pain score after treatment

Description

Visual analog scale (VAS) is decresed more than 2.5 or VAS is less than 3.5.

Time Frame

baseline and 24 months after treatment.

Secondary Outcome Measure Information:

Title

Appropriate conservative treatment period

Description

Appropriate conservative treatment period, Cost-effectiveness analysis (Quality of life index (SF-36, EQ-5D-5L), Direct medical cost)

Time Frame

1, 3, 6, 12, 24 months after treatment.

Title

the change of pain score (Visual anlogue pain score) after time of treatment

Description

compare the trend of change with mixed-model

Time Frame

1, 3, 6, 12, 24 months after treatment.

Title

Cost-effectiveness

Description

Compare direct cost after each treatment

Time Frame

24 month after treatment

Title

Quality of life index (SF-36)

Description

compare the trend of change with mixed-model

Time Frame

1, 3, 6, 12, 24 months after treatment.

Title

Quality of life index (EQ-5D-5L)

Description

compare the trend of change with mixed-model

Time Frame

1, 3, 6, 12, 24 months after treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chun Kee Chung, Professor

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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