Seoul National University Hospital
Seoul, 110-744, South Korea
NCT Number: NCT02883569
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Seoul, 110-744, South Korea
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FDA approved surgical procedures
epidural block
educated exercise
FDA approved medication such as ibuprofen, naxoprofen etc.
Other names: NSAID
FDA approved surgical procedure such as lamiectom and, laminotomy
FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF
FDA approved opioid drug such as codeine, oxycontin, IRcodon
Other names: opioid
FDA approved epidural adhesiolysis with catheter or endoscope
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.
Time frame: 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)
Time frame: 1, 3, 6, 12, 24 months after treatment.
compare the trend of change with mixed-model
Time frame: 24 month after treatment
Compare direct cost after each treatment
Time frame: 1, 3, 6, 12, 24 months after treatment.
compare the trend of change with mixed-model
Time frame: 1, 3, 6, 12, 24 months after treatment.
compare the trend of change with mixed-model
Seoul National University Hospital
Other
Randomized Control Trial. Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain
Acronym: CES_SNS_LBP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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