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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002033

Enrollment

1102

Registered

2016-09-01

Start date

2016-08-16

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : randomized controlled trial for patients with HIVD, Lumbar spinal stenosis without instability and with instability. Web based system is used for randomization.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 ?

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactChi Heon Kim

Seoul National University Hospital

chiheon1@gmail.com+82-2-2072-3398

Outcome results