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

NCT02883569 | Completed DMC

• 1 other identifier: LBP
• Study Type: interventional
• Target: 1,102
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Appropriate conservative treatment period

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

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

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

• Cost-effectiveness

  24 month after treatment

• Quality of life index (SF-36)

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

• Quality of life index (EQ-5D-5L)

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

Study Arms (8)

HIVD-OP

ACTIVE COMPARATOR

open or endoscopic discectomy

Procedure: open or endoscopic discectomy; Procedure: decompression; Procedure: instrumentation and fusion

HIVD-NonOP

EXPERIMENTAL

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

Procedure: epidural block; Other: exercise; Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac; Drug: codeine, oxycontine, IRcodone, Tramadol; Procedure: epidural adhesiolysis

LSS w/o instability -OP

ACTIVE COMPARATOR

decompression, instrumentation and fusion

Procedure: decompression; Procedure: instrumentation and fusion

LSS w/o instability -NonOP

EXPERIMENTAL

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

Procedure: epidural block; Other: exercise; Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac; Drug: codeine, oxycontine, IRcodone, Tramadol; Procedure: epidural adhesiolysis

LSS w/ instability - OP

ACTIVE COMPARATOR

decompression, instrumentation and fusion

Procedure: decompression; Procedure: instrumentation and fusion

LSS w/ instability - NonOP

EXPERIMENTAL

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

Procedure: epidural block; Other: exercise; Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac; Drug: codeine, oxycontine, IRcodone, Tramadol; Procedure: epidural adhesiolysis

No intervention group

ACTIVE COMPARATOR

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

Other: exercise; Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac; Drug: codeine, oxycontine, IRcodone, Tramadol; Procedure: epidural adhesiolysis

Intervention group

EXPERIMENTAL

epidural block, epidural adhesiolysis

Procedure: epidural block

Interventions

open or endoscopic discectomy PROCEDURE

FDA approved surgical procedures

HIVD-OP

epidural block PROCEDURE

epidural block

HIVD-NonOP; Intervention group; LSS w/ instability - NonOP; LSS w/o instability -NonOP

exercise OTHER

educated exercise

HIVD-NonOP; LSS w/ instability - NonOP; LSS w/o instability -NonOP; No intervention group

ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac DRUG

FDA approved medication such as ibuprofen, naxoprofen etc.

Also known as: NSAID

HIVD-NonOP; LSS w/ instability - NonOP; LSS w/o instability -NonOP; No intervention group

decompression PROCEDURE

FDA approved surgical procedure such as lamiectom and, laminotomy

HIVD-OP; LSS w/ instability - OP; LSS w/o instability -OP

instrumentation and fusion PROCEDURE

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

HIVD-OP; LSS w/ instability - OP; LSS w/o instability -OP

codeine, oxycontine, IRcodone, Tramadol DRUG

FDA approved opioid drug such as codeine, oxycontin, IRcodon

Also known as: opioid

HIVD-NonOP; LSS w/ instability - NonOP; LSS w/o instability -NonOP; No intervention group

epidural adhesiolysis PROCEDURE

FDA approved epidural adhesiolysis with catheter or endoscope

HIVD-NonOP; LSS w/ instability - NonOP; LSS w/o instability -NonOP; No intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• Gangnam Severance Hospital: collaborator
• Severance Hospital: collaborator
• Korea University Guro Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Degeneration; Spinal Stenosis

Interventions

Anesthesia, Epidural; Exercise; Ibuprofen; Cyclooxygenase 2 Inhibitors; aceclofenac; Anti-Inflammatory Agents, Non-Steroidal; Decompression; Gene Fusion; Codeine; Tramadol; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena; Recombination, Genetic; Genetic Phenomena; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids; Narcotics; Central Nervous System Depressants; Central Nervous System Agents

Study Officials

• Chun Kee Chung, Professor

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 30, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

KR (1)