Low Back PainCES_SNS_LBPNCT02883569
Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain
A study testing open or endoscopic discectomy, epidural block and exercise in people with Low Back Pain, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- open or endoscopic discectomy, epidural block and exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,102 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Low Back Pain
- Being tested
- open or endoscopic discectomy, epidural block, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, decompression
- Keywords
- Low back pain, Intervertebral Disc Degeneration, Spinal stenosis, Comparative Effectiveness Research, Cost-Benefit Analysis
- Medical subject headings
- Low Back Pain, Intervertebral Disc Degeneration, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open or endoscopic discectomyProcedure or surgery
FDA approved surgical procedures
epidural blockProcedure or surgery
epidural block
exerciseOther
educated exercise
ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenacDrug
Also called NSAID
FDA approved medication such as ibuprofen, naxoprofen etc.
decompressionProcedure or surgery
FDA approved surgical procedure such as lamiectom and, laminotomy
instrumentation and fusionProcedure or surgery
FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF
codeine, oxycontine, IRcodone, TramadolDrug
Also called opioid
FDA approved opioid drug such as codeine, oxycontin, IRcodon
epidural adhesiolysisProcedure or surgery
FDA approved epidural adhesiolysis with catheter or endoscope
| Study group | Role | What they receive |
|---|---|---|
| HIVD-OP | Active comparator | open or endoscopic discectomy Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: exercise; Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac; Drug: codeine, oxycontine, IRcodone, Tramadol; Procedure: epidural adhesiolysis |
| Intervention group | Experimental | epidural block, epidural adhesiolysis Receives: Procedure: epidural block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 24 months after treatment.
Secondary outcomes (5)
Appropriate conservative treatment period
Appropriate conservative treatment period, Cost-effectiveness analysis (Quality of life index (SF-36, EQ-5D-5L), Direct medical cost)
Measured: 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
Measured: 1, 3, 6, 12, 24 months after treatment.
Cost-effectiveness
Compare direct cost after each treatment
Measured: 24 month after treatment
Quality of life index (SF-36)
compare the trend of change with mixed-model
Measured: 1, 3, 6, 12, 24 months after treatment.
Quality of life index (EQ-5D-5L)
compare the trend of change with mixed-model
Measured: 1, 3, 6, 12, 24 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2020
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Gangnam Severance Hospital, Severance Hospital, Korea University Guro Hospital
- Responsible party
- Principal investigator, Chun Kee Chung, Seoul National University Hospital
- Investigators
- Chun Kee Chung, Professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883569
- Sponsor's protocol ID
- LBP
- Acronym
- CES_SNS_LBP
- Status last verified
- Apr 2023
- First submitted
- 25 Jul 2016
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial. Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT02883569
- Acronym / sponsor ID
- CES_SNS_LBP / LBP
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Intervertebral Disc Degeneration, Spinal stenosis, Comparative Effectiveness Research, Cost-Benefit Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,102 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Gangnam Severance Hospital, Severance Hospital, Korea University Guro Hospital
- Study start
- Sep 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| HIVD-OP | Active comparator | Procedure: open or endoscopic discectomy, Procedure: decompression, Procedure: instrumentation and fusionopen or endoscopic discectomy |
| HIVD-NonOP | Experimental | Procedure: epidural block, Other: exercise, Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, Drug: codeine, oxycontine, IRcodone, Tramadol, Procedure: epidural adhesiolysisepidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol |
| LSS w/o instability -OP | Active comparator | Procedure: decompression, Procedure: instrumentation and fusiondecompression, instrumentation and fusion |
| LSS w/o instability -NonOP | Experimental | Procedure: epidural block, Other: exercise, Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, Drug: codeine, oxycontine, IRcodone, Tramadol, Procedure: epidural adhesiolysisepidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol |
| LSS w/ instability - OP | Active comparator | Procedure: decompression, Procedure: instrumentation and fusiondecompression, instrumentation and fusion |
| LSS w/ instability - NonOP | Experimental | Procedure: epidural block, Other: exercise, Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, Drug: codeine, oxycontine, IRcodone, Tramadol, Procedure: epidural adhesiolysisepidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol |
| No intervention group | Active comparator | Other: exercise, Drug: ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, Drug: codeine, oxycontine, IRcodone, Tramadol, Procedure: epidural adhesiolysisexercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol |
| Intervention group | Experimental | Procedure: epidural blockepidural block, epidural adhesiolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open or endoscopic discectomyFDA approved surgical procedures | Procedure or surgery | HIVD-OP |
| epidural blockepidural block | Procedure or surgery | HIVD-NonOP, Intervention group, LSS w/ instability - NonOP, LSS w/o instability -NonOP |
| exerciseeducated exercise | Other | HIVD-NonOP, LSS w/ instability - NonOP, LSS w/o instability -NonOP, No intervention group |
| ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenacAlso: NSAIDFDA approved medication such as ibuprofen, naxoprofen etc. | Drug | HIVD-NonOP, LSS w/ instability - NonOP, LSS w/o instability -NonOP, No intervention group |
| decompressionFDA approved surgical procedure such as lamiectom and, laminotomy | Procedure or surgery | HIVD-OP, LSS w/ instability - OP, LSS w/o instability -OP |
| instrumentation and fusionFDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF | Procedure or surgery | HIVD-OP, LSS w/ instability - OP, LSS w/o instability -OP |
| codeine, oxycontine, IRcodone, TramadolAlso: opioidFDA approved opioid drug such as codeine, oxycontin, IRcodon | Drug | HIVD-NonOP, LSS w/ instability - NonOP, LSS w/o instability -NonOP, No intervention group |
| epidural adhesiolysisFDA approved epidural adhesiolysis with catheter or endoscope | Procedure or surgery | HIVD-NonOP, LSS w/ instability - NonOP, LSS w/o instability -NonOP, No intervention group |
Primary outcome
Compare the change of pain score after treatment
Time frame: baseline and 24 months after treatment.
Visual analog scale (VAS) is decresed more than 2.5 or VAS is less than 3.5.
5 secondary outcomes
Appropriate conservative treatment period
Time frame: 1, 3, 6, 12, 24 months after treatment.
the change of pain score (Visual anlogue pain score) after time of treatment
Time frame: 1, 3, 6, 12, 24 months after treatment.
Cost-effectiveness
Time frame: 24 month after treatment
Quality of life index (SF-36)
Time frame: 1, 3, 6, 12, 24 months after treatment.
Quality of life index (EQ-5D-5L)
Time frame: 1, 3, 6, 12, 24 months after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Kee Chung, Professor principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open or endoscopic discectomy, epidural block and exercise in people with Low Back Pain, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the change of pain score after treatment (time frame: baseline and 24 months after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.