Nonsurgical Integrative Treatments for Symptomatic Degenerative Lumbar Spondylolisthesis: A Multinational Randomized Controlled Clinical Trial.

Abstract

To evaluate the safety and effectiveness of a novel nonsurgical integrative treatment, Mokhuri Chuna (MC), in patients with symptomatic degenerative lumbar spondylolisthesis (DLS). This multinational randomized controlled trial was conducted at Mokhuri Oriental Medicine Hospital, Seoul, South Korea, and Mayo Clinic, Rochester, Minnesota, from June 2017, to December 2022. Patients with symptomatic DLS were randomized 1:1 by study site to receive MC or standard care (SC) twice weekly for 5 weeks, followed by a 96-week posttreatment evaluation period. The primary endpoint was change in back pain (VAS). Secondary endpoints included changes in leg pain (VAS), physical function (ODI), health-related quality of life (EQ-5D), walking capacity, and safety. Patients were evaluated at baseline (Week 1), weekly during Week 2 through 6, and at 7, 18, 30, 54, and 102 weeks. Data analysis was performed in April 2024. In the randomized cohort of 115 patients (mean ± SD age, 59.97±10.96 years; 56 females [48.7%]), 58 patients were assigned to MC and 57 to SC. Baseline characteristics were comparable between groups. In the modified intention-to-treat analysis of 112 patients (56 per group), the MC group showed significant improvements in back pain (-10.27; 95% CI, -19.22 to -1.32; P=.02) and leg pain (-11.91; 95% CI, -21.15 to -2.68; P=.01) compared with the SC group. No significant differences were observed in ODI, EQ-5D, or walking capacity. No treatment-related serious adverse events were reported in either group. In patients with symptomatic DLS, MC was safe and more effective than SC for relieving back and leg pain, offering a promising nonsurgical treatment option. clinicaltrials.gov Identifier: NCT03107468.