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

Not Applicable

Completed

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

• Registration Number: NCT02883569
• Lead Sponsor: Seoul National University Hospital

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.

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 Timeline

• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-30
• Study Start: 2016-09
• Primary Completion: 2020-12
• Study Completion: 2021-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LSS w/ instability - OP	decompression	decompression, instrumentation and fusion
LSS w/ instability - OP	instrumentation and fusion	decompression, instrumentation and fusion
LSS w/o instability -NonOP	epidural block	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
LSS w/ instability - NonOP	ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
HIVD-OP	instrumentation and fusion	open or endoscopic discectomy
HIVD-NonOP	ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
HIVD-NonOP	codeine, oxycontine, IRcodone, Tramadol	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
LSS w/o instability -NonOP	ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
LSS w/o instability -NonOP	epidural adhesiolysis	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
LSS w/ instability - NonOP	codeine, oxycontine, IRcodone, Tramadol	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
LSS w/ instability - NonOP	exercise	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
LSS w/o instability -NonOP	exercise	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
No intervention group	codeine, oxycontine, IRcodone, Tramadol	exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
Intervention group	epidural block	epidural block, epidural adhesiolysis
HIVD-OP	open or endoscopic discectomy	open or endoscopic discectomy
HIVD-OP	decompression	open or endoscopic discectomy
HIVD-NonOP	exercise	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
HIVD-NonOP	epidural adhesiolysis	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
LSS w/o instability -NonOP	codeine, oxycontine, IRcodone, Tramadol	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
LSS w/o instability -OP	instrumentation and fusion	decompression, instrumentation and fusion
No intervention group	epidural adhesiolysis	exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
HIVD-NonOP	epidural block	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
LSS w/o instability -OP	decompression	decompression, instrumentation and fusion
LSS w/ instability - NonOP	epidural block	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
LSS w/ instability - NonOP	epidural adhesiolysis	epidural block, epidural adhesiolysis, exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
No intervention group	exercise	exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol
No intervention group	ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac	exercise, ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac, codeine, oxycontine, IRcodone, Tramadol

Primary Outcome Measures

Name	Time	Method
Compare the change of pain score after treatment	baseline and 24 months after treatment.	Visual analog scale (VAS) is decresed more than 2.5 or VAS is less than 3.5.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of