Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpa… (NCT03750591) | Clinical Trial Compass
CompletedNot Applicable
Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation
South Korea1,000 participantsStarted 2018-03-31
Plain-language summary
Observational study on the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation
Who can participate
Age range19 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI taken within 3 years
✓. Patients with radiculopathy (ipsilateral or bilateral radiculopathy)
✓. Patients whose pain intensity of back pain or radiating leg pain is NRS≥5
✓. Patients aged 19 to 70
✓. Patients who have agreed to participate in the clinical study and given written informed consent
✓. Patients admitted to a Korean medicine hospital for treatment
Exclusion criteria
✕. Patients who have been diagnosed with a serious disease that may cause low back pain or neck pain (e.g. spinal metastasis of tumor, acute fracture, spinal dislocation)
✕. Patients admitted due to pain caused by traffic accidents
✕. Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury
✕. Patients with severe mental illness
✕. Patients with difficulty or refusal to give sign written informed consent
✕. Patients for whom the researchers judge participation in the clinical study to be difficult
✕
What they're measuring
1
NRS change from Baseline NRS at discharge
Timeframe: Baseline (admission), discharge (up to 14 weeks after baseline)
2
ODI change from Baseline ODI at discharge
Timeframe: Baseline (admission), discharge (up to 14 weeks after baseline)