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

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

Interventions

PROCEDURE

open or endoscopic discectomy

FDA approved surgical procedures

PROCEDURE

epidural block

epidural block

OTHER

exercise

educated exercise

DRUG

ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac

FDA approved medication such as ibuprofen, naxoprofen etc.

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

DRUG

codeine, oxycontine, IRcodone, Tramadol

FDA approved opioid drug such as codeine, oxycontin, IRcodon

PROCEDURE

epidural adhesiolysis

FDA approved epidural adhesiolysis with catheter or endoscope

Sponsors & Collaborators

• Seoul National University Bundang Hospital

  collaborator OTHER

• Gangnam Severance Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Korea University Guro Hospital

  collaborator OTHER

• Seoul National University Hospital

  lead OTHER

Principal Investigators

• Chun Kee Chung, Professor · Seoul National University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2020-12-31

Completion

2021-12-31

Countries

• South Korea

Study Locations