Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients with Low Back Pain (CES_SNS_LBP)

Not Applicable

Recruiting

• Conditions: Diseases of the musculo-skeletal system and connective tissue

• Registration Number: KCT0002033
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

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

Inclusion Criteria

1.Herniated intervertebral disease
?Inclusion criteria
?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 instabiltiy
?Inclusion criteria
?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
?Inclusion criteria
?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
?Inclusion criteria
?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
?Exclusion criteria
?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
?Exclusion criteria
?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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment success rate, Visual analog scale (VAS) is decresed more than 2.5 or VAS is less than 3.5.

Secondary Outcome Measures

Name	Time	Method
Appropriate conservative treatment period;Cost-effectiveness analysis (Quality of life index (SF-36)) ;Cost-effectiveness analysis (Quality of life index (EQ-5D-5L)) ;Direct medical cost