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 range
19 Years – 70 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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
. Diagnosis of lumbar spondylolisthesis of Meyerding Ⅱ or higher by a doctor of medicine or doctor of Korean medicine through X-ray or MRI