Pharmacopuncture therapy versus usual care for lumbar spinal stenosis: A randomized controlled trial.

Background: The prevalence of lumbar spinal stenosis (LSS) is rising worldwide, particularly in aging societies, increasing the need for effective conservative treatments. Pharmacopuncture therapy (PPT), which involves injecting herbal extracts into targets such as acupoints, muscles or nerves to improve lumbar pain and function, is widely utilized in Korean clinical settings; however, high-quality evidence remains limited. We evaluated the effectiveness and safety of PPT, compared with conventional medicine-based usual care (UC). Methods: This multicenter, pragmatic, randomized controlled trial included PPT and UC groups (1:1 ratio). Patients with LSS received treatment twice weekly for 12 weeks, with follow-ups at weeks 13, 25, and 53. Outcomes related to pain, functional disability, and quality of life were measured. Results: Ninety-six patients were randomized and included in the intention-to-treat analysis. Change in the numeric rating scale (NRS) score for dominant pain from baseline to week 13 showed a significantly greater reduction of 2.7 points in the PPT group than in the UC group. The PPT group also showed significant improvements in other secondary outcomes, and these effects were sustained until week 53. A survival analysis of patients with a ≥50 % NRS score reduction over 53 weeks indicated significantly faster recovery in the PPT group than in the UC group. No serious adverse events were observed. Conclusion: Compared with UC, PPT was associated with significantly greater reductions in low back and leg pain and superior improvements in function and quality of life in patients with LSS. These findings support prioritizing PPT as an effective conservative treatment for LSS. Trial registration: This study was registered at CRIS (cris.nih.go.kr; KCT0007145) and ClinicalTrials.gov (NCT05242497).