Format

Send to

Choose Destination
Medicine (Baltimore). 2018 May;97(19):e0667. doi: 10.1097/MD.0000000000010667.

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

Author information

1
Department of Spine Center, Mokhuri Neck and Back Hospital, Seoul.
2
Hongik Neurosurgery Hospital, Seongnam, Republic of Korea.
3
Department of Physical Medicine and Rehabilitation.
4
Department of Anesthesiology, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA.
5
Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul, Republic of Korea.

Abstract

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).

PMID:
29742708
PMCID:
PMC5959416
DOI:
10.1097/MD.0000000000010667
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Wolters Kluwer Icon for PubMed Central
Loading ...
Support Center