Observational study on effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation
Lee, Y.J.; Kim, J.; Kim, M.-R.; Kim, J.; Kim, M.-Y.; Cho, H.-W.; Lee, S.-H.; Ha, I.
Medicine 99(21): E20083
ISSN/ISBN: 1536-5964 PMID: 32481274 DOI: 10.1097/md.0000000000020083
We developed a protocol for a prospective registry to prove the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation. We plan on recruiting 1000 inpatients receiving integrative Korean medicine treatment for lumbar intervertebral disc herniation at four spine specialized Korean medical hospitals. Patients enrolled in the registry will be evaluated at the time of hospitalization, 2 weeks after hospitalization, at discharge, and 6 months after hospitalization on predefined outcome variables such as intensity of back and leg pain, Oswestry Disability Index, quality of life, Patient Global Impression of Change, and adverse effects. The protocol of this study was registered in CRIS (KCT0003709) and Clinical trial gov (NCT03750591). This study is significant in that it cannot only be a basis for safety-related evidence of complementary alternative medicine, which has been lacking, but it also gives clear evidence on the effectiveness and validity of treatment effects such as accompaniment of stenosis, sex, age, and type of disc herniation.