The effectiveness and safety of nonsurgical integrative interventions for symptomatic lumbar spinal spondylolisthesis: A randomized controlled multinational, multicenter trial protocol

BACKGROUND: Surgery is generally accepted as the main therapeutic option for symptomatic lumbar spondylolisthesis. However, new nonsurgical therapeutic options need to be explored for this population. OBJECTIVES: The objective of this study is to assess the effectiveness and safety of a 5-week Mokhuri treatment program compared with conventional nonsurgical treatments for symptomatic lumbar spondylolisthesis. METHODS: This is a study protocol for a multinational, multicenter clinical randomized controlled trial comparing the effectiveness and safety of 5 weeks of nonsurgical integrative treatments (a Mokhuri treatment program consisting of Chuna, acupuncture, and patient education) with nonsurgical conventional treatments (drugs for pain relief, epidural steroid injections, and physical therapy). Clinical outcomes including visual analogue scale (VAS) scores ranging from 0 to 100 for low back pain and leg pain, EQ-5D scores, Oswestry disability index (ODI) scores, Roland–Morris Disability Questionnaire (RMDQ) scores, Zurich Claudication Questionnaire (ZCQ) scores, walking duration and distance without leg pain, and a 5-minute treadmill test, and the ratio between the actual duration of participation and the originally scheduled duration in each group, the presence of any additional spondylolisthesis treatments, the types of concomitant treatments during the follow-up period, and adverse events (AEs) will be assessed at 7 weeks, 18 weeks, 30 weeks, 54 weeks, and 102 weeks after the end of the treatments. CONCLUSION AND DISCUSSION: The results of this study will provide clinical evidence on nonsurgical integrative interventions for patients with symptomatic lumbar spondylolisthesis. CLINICAL TRIAL REGISTRY: clinicaltrials.gov (NCT03107468)