A Long-Term Prospective Observational Study on the Effectiveness and Safety of Integrative Korean Medicine Treatment for Patients with Lumbar Stenosis

Background: To evaluate the long-term effectiveness and safety of integrative Korean medicine (IKM) treatment of lumbar spinal stenosis (LSS), pain, functional disability, and quality of life were assessed over a 1-year follow-up period.Methods: A multi-center prospective observational study of patients with LSS who received IKM (acupuncture, pharmacopuncture, Chuna manual therapy, and herbal medicine) for 4 months was performed over 1 year. Outcome measures included scores from the numeric rating scale (NRS) for low back and leg pain, Oswestry Disability Index, Zurich Claudication Questionnaire, walking distance without pain, and EuroQol-5-Dimension-5-Level, measured at regular intervals (2-4 weeks) during the treatment period, with follow-up at 20, 24, and 52 weeks from baseline.Results: There were 111 patients in the intention-to-treat analysis. At baseline, the mean dural sac cross-sectional area was 65.8 ± 31.7 mm² and > 90% of patients had a morphological Grade ≥ B. From baseline to 20 weeks, the low back pain NRS, leg pain NRS, and Oswestry Disability Index scores significantly decreased from 7.06 to 2.89, 6.51 to 2.61, and 42.58 to 25.00, respectively. In addition, the EuroQol-5-Dimension-5-Level score significantly improved from 0.57 to 0.76. All other outcomes showed significant improvements which were maintained throughout the follow-up period. Patients with a history of spinal surgery achieved clinical outcomes comparable with their counterparts by the end of the follow-up period, albeit at a slower rate.Conclusion: IKM treatment appeared to be associated with clinically meaningful, sustained improvement in pain, disability, and quality of life among patients with LSS.