title: Nonsurgical Korean Integrative Treatments for Symptomatic Lumbar Spinal Stenosis: A Three-Armed Randomized Controlled Pilot Trial Protocol.
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.
authors.affiliation: Department of Spine Center, Mokhuri Neck & Back Hospital, Seoul 06272, Republic of Korea.
authors.forename: Kiok
authors.initials: K
authors.lastname: Kim
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
authors.forename: Kyung-Min
authors.initials: KM
authors.lastname: Shin
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea; Korean Medicine Life Science, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon 34113, Republic of Korea.
authors.forename: Jun-Hwan
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Mibyeong Research Center, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
authors.forename: Bok-Nam
authors.initials: BN
authors.lastname: Seo
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
authors.forename: So-Young
authors.initials: SY
authors.lastname: Jung
authors.affiliation: Department of Spine Center, Mokhuri Neck & Back Hospital, Seoul 06272, Republic of Korea.
authors.forename: Yousuk
authors.initials: Y
authors.lastname: Youn
authors.affiliation: Department of Spine Center, Mokhuri Neck & Back Hospital, Seoul 06272, Republic of Korea.
authors.forename: Sang Ho
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Department of Spine Center, Mokhuri Neck & Back Hospital, Seoul 06272, Republic of Korea.
authors.forename: Jaehong
authors.initials: J
authors.lastname: Kim
authors.affiliation: Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN 55905, USA; Department of Anesthesiology, Division of Pain Medicine, Mayo Clinic, Rochester, MN 55905, USA.
authors.forename: Wenchun
authors.initials: W
authors.lastname: Qu
authors.affiliation: Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul 02447, Republic of Korea.
authors.forename: Tae-Hun
authors.identifier: 0000-0002-8448-3219
authors.initials: TH
authors.lastname: Kim