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NCT03107468

Korean Medicine for Symptomatic Lumbar Spinal Spondylolisthesis

Status unknown NA Last updated 6 January 2021
What this trial tests

NA trial testing Mokhuri intensive treatment in Spondylolisthesis, Lumbosacral Region in 115 participants. Status unknown.

Timeline
15 December 2017
Primary endpoint
31 December 2022
31 December 2022

Quick facts

Lead sponsorKim Ki Ok
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment115
Start date15 December 2017
Primary completion31 December 2022
Estimated completion31 December 2022
Sites2 locations across United States, South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Kim Ki Ok

Who can join

Adults 19 to 78, any sex, with Spondylolisthesis, Lumbosacral Region. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a clinical trial for evaluating the safety and effectiveness of the Mokhuri intensive treatment program regarding pain and function before and after treatment between a group receiving the Mokhuri intensive treatment program (Chuna, acupuncture, and patient education) for five weeks and another group receiving non-surgical conventional standard treatment (drugs for pain relief, epidural steroid injection treatment, and physical therapy). The trial will be conducted through international cooperation between Mayo Clinic in the United States and Mokhuri Oriental Medicine Hospital in Korea. All subjects in Korea and the US will be selected based on the same inclusion criteria and exclusion criteria. All subjects in the treatment arm will receive the same treatment in Korea and the US. In collaboration and with the support of Mayo Clinic's Department of Integrative Medicine and Health, and to ensure treatment consistency between Korea and the US, an acupuncturist from the USA will travel to Korea and train on-site for one month in Mokhuri hospital. The trial subjects who agree to participate in the clinical trial after providing informed consent will receive the required examinations and tests according to the clinical trial plan. If they are appropriate for this clinical trial and eligible based on the Inclusion and exclusion criteria, they will be randomly assigned to the group that will undergo the focused Mokhuri intensive treatment program and to the group that will receive non-surgical conventional treatment on their second visit. All the subjects in this study will be educated regarding the study procedure and scheduled visits and will participate in the allocated treatments for five weeks. Afterwards, clinical outcomes of both groups will be evaluated after end of the treatments from between a week and five weeks (within +7 days). The clinical trial ends after the follow-up evaluations that will take place 12 weeks, 24 weeks, 48 weeks, and 96 weeks after the end of the treatment evaluation.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The effectiveness and safety of nonsurgical integrative interventions for symptomatic lumbar spinal spondylolisthesis: A randomized controlled multinational, multicenter trial protocol.
    Kim K, Youn Y, Lee SH, Choi JC, et al · · 2018 · cited 4× · PMID 29742708 · DOI 10.1097/md.0000000000010667
  2. Nonsurgical Integrative Treatments for Symptomatic Degenerative Lumbar Spondylolisthesis: A Multinational Randomized Controlled Clinical Trial.
    Kim K, Yan D, Bauer BA, Choi JC, et al · · 2026 · PMID 41176728 · DOI 10.1016/j.mayocp.2025.05.030

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