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

Low Back Pain Clinical Trial

— CES_SNS_LBP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883569
• Other study ID #: LBP
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2021

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1102
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• open or endoscopic discectomy
FDA approved surgical procedures
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Seoul National University Hospital	Gangnam Severance Hospital, Korea University Guro Hospital, Seoul National University Bundang Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Cost-effectiveness	Compare direct cost after each treatment	24 month after treatment
Secondary	Quality of life index (SF-36)	compare the trend of change with mixed-model	1, 3, 6, 12, 24 months after treatment.
Secondary	Quality of life index (EQ-5D-5L)	compare the trend of change with mixed-model	1, 3, 6, 12, 24 months after treatment.