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Evidence-Based Complementary and Alternative Medicine
Volume 2016, Article ID 2913248, 7 pages
http://dx.doi.org/10.1155/2016/2913248
Research Article

Nonsurgical Korean Integrative Treatments for Symptomatic Lumbar Spinal Stenosis: A Three-Armed Randomized Controlled Pilot Trial Protocol

1Department of Spine Center, Mokhuri Neck & Back Hospital, Seoul 06272, Republic of Korea
2Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea
3Korean Medicine Life Science, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon 34113, Republic of Korea
4Mibyeong Research Center, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea
5Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN 55905, USA
6Department of Anesthesiology, Division of Pain Medicine, Mayo Clinic, Rochester, MN 55905, USA
7Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul 02447, Republic of Korea

Received 17 November 2015; Revised 8 January 2016; Accepted 14 January 2016

Academic Editor: Lise Hestbaek

Copyright © 2016 Kiok Kim et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

This is a study protocol for a pilot three-armed randomized controlled trial on nonsurgical integrative Korean medicinal treatment for symptomatic lumbar spinal stenosis (LSS). Thirty-six participants who have been diagnosed with (LSS) and recommended for spinal surgery by neurosurgeons or orthopedics and have had spinal symptoms such as severe low back pain and neurological claudication regardless of at least three months of conservative treatments will be recruited. Participants will be randomly assigned to be one of the three intervention groups, including the Mokhuri treatment program group 1 or 2 or usual care group. All treatments will be administered in inpatient units over a period of 4 weeks. The primary outcomes are 0 to 100 Visual Analogue Scales for low back pain and leg pain and the secondary outcomes are Oswestry Disability Index; EQ-5D; Roland-Morris Disability Questionnaire; Oxford Claudication Score; physical function test, including treadmill test, walking duration, and distance assessment for free leg pain; radiologic testing; and adverse events which will be assessed during the 4-week treatment period as well as after 3 and 6 months of follow-up. Then, we will assess the feasibility of the clinical trial design as well as a nonsurgical integrative treatment program. This trial is registered with CRIS registration number: KCT0001218.