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

Randomized Control Trial. 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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: open or endoscopic discectomy; Procedure: decompression; Procedure: instrumentation and fusion; Procedure: epidural block; Other: exercise; Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac; Drug: codeine, oxycontine, IRcodone, Tramadol; Procedure: epidural adhesiolysis

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
• Enrollment (Actual): 1102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and 24 months after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriate conservative treatment period	Appropriate conservative treatment period, Cost-effectiveness analysis (Quality of life index (SF-36, EQ-5D-5L), Direct medical cost)	1, 3, 6, 12, 24 months after treatment.
the change of pain score (Visual anlogue pain score) after time of treatment	compare the trend of change with mixed-model	1, 3, 6, 12, 24 months after treatment.
Cost-effectiveness	Compare direct cost after each treatment	24 month after treatment
Quality of life index (SF-36)	compare the trend of change with mixed-model	1, 3, 6, 12, 24 months after treatment.
Quality of life index (EQ-5D-5L)	compare the trend of change with mixed-model	1, 3, 6, 12, 24 months after treatment.

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital; Korea University Guro Hospital; Gangnam Severance Hospital; Severance Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Low back pain; Cost-Benefit Analysis; Comparative Effectiveness Research; Spinal stenosis; Intervertebral Disc Degeneration
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Ibuprofen; Tramadol; Codeine; Cyclooxygenase 2 Inhibitors; Aceclofenac
• Other Study ID Numbers: LBP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED