Pharmacopuncture Therapy as an Adjunctive Treatment for Patients with Lumbar Spinal Stenosis: A Pragmatic Randomized Controlled Pilot Trial

Yoona Oh,1,2,* Chang-Hyun Han,3,4,* Yeonhak Kim,1 Jihun Kim,1 Changsop Yang,3 Young Eun Choi,5 Byoung-Kab Kang,3 Kun Hyung Kim,1,2 Gi Young Yang,1,2 Byung Ryul Lee,1,2 Eunseok Kim1,2 1Department of Acupuncture and Moxibustion Medicine, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea; 2Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea; 3KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; 4Korean Convergence Medicine, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; 5Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea*These authors contributed equally to this workCorrespondence: Eunseok Kim, Division of Clinical Medicine, School of Korean Medicine, Pusan National University, 49, Busandaehak-ro, Mulgeum-eup, Yangsan-si, Gyeongnam, 50612, Republic of Korea, Tel +82 55 360 5950, Fax +82 55 360 5890, Email eskim@pusan.ac.krPurpose: Pharmacopuncture therapy (PPT) combines medicinal extracts with acupuncture and is widely used as an adjunct in clinical practice. This study assessed the safety and feasibility of PPT in addition to conventional Korean Medicine treatment (CKMT), including electroacupuncture, cupping and infra-red, for lumbar spinal stenosis (LSS).Patients and Methods: Forty patients diagnosed with LSS were randomly assigned to undergo PPT with CKMT (experimental group) or CKMT alone (control group) at a 1:1 ratio, receiving 10 sessions of each intervention over five weeks. The primary clinical outcome was measured using the 100-mm Visual Analog Scale (VAS) for buttock and leg pain five weeks post-treatment. Secondary outcomes included clinically important difference (CID), Zurich Claudication Questionnaire, self-reported walking capacity, Modified–Modified Schober test, EuroQol 5-dimension 5-level questionnaire, and the patient’s global impression of change. The adverse events were assessed at each visit. The analysis of covariance was conducted to compare between two groups.Results: Intervention completion rates were 95% and 100% in the experimental and control groups, respectively. No statistically significant differences were found between groups regarding the primary outcome (adjusted mean difference: 8.0; 95% confidence interval: − 1.4– 17.4). The mean difference in the 100-mm VAS for low back pain at week 5 (adjusted mean difference: 12.9; 95% confidence interval: 2.4– 23.4) and the proportion of patients who reached the minimum CID was higher in the experimental group than in the control group. However, no significant differences were observed with other secondary outcomes. One patient in the experimental group experienced a systemic skin rash that resolved the same day, whereas the adverse events in the other group were mild and transient.Conclusion: This trial demonstrated the feasibility of add-on effects and the safety of pharmacopuncture in patients with LSS. Further studies are warranted to evaluate the add-on effects of PPT in treating LSS.Trial Registration: Clinical Research Information Service (CRIS), KCT0007229; registered on April 26, 2022.Keywords: lumbar spinal stenosis, pharmacopuncture therapy, add-on effect, conventional Korean medicine treatment, pragmatic randomized pilot trial