PMID- 30992679 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220408 IS - 1178-7090 (Print) IS - 1178-7090 (Electronic) IS - 1178-7090 (Linking) VI - 12 DP - 2019 TI - Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial. PG - 1103-1113 LID - 10.2147/JPR.S173178 [doi] AB - BACKGROUND: Lumbar spinal stenosis (LSS) is a chronic condition that causes low back pain and neurogenic claudication, often resulting in significant limitation of daily activities. In this open-label randomized controlled pilot study, we assessed the safety and feasibility of 4-week novel integrative inpatient treatments for LSS. METHODS: Thirty-six symptomatic LSS patients were randomly and equally allocated to one of the three groups: Mokhuri Chuna treatment 1 (MT1) group, Mokhuri Chuna treatment 2 (MT2) group, or conventional management treatment (CMT) group. MT1 patients were treated with herbal medication, Mokhuri Chuna, and acupuncture, and received daily physician consultation; MT2 patients were treated with Mokhuri Chuna and acupuncture without any herbal medication, and received daily physician consultation; and CMT patients received conventional pain management therapy that included epidural steroid injection, oral NSAID, and muscle relaxant medication, along with daily physiotherapy. The primary outcome of this pilot study was safety as measured by the type and incidence of adverse events (AEs). The secondary outcome measures included VAS score for low back pain and leg pain, Oswestry Disability Index, Oxford Claudication Score (OCS), walking capacity on a 50 m flat track and treadmill, and EuroQol-5D score. Magnetic resonance imaging was also performed up to 6 months after treatment cessation. RESULTS: Thirty-four treated patients were included in the analysis, based on the modified intention-to-treat principle. No serious AEs were observed or reported. Compared to the CMT group, the MT1 and MT2 groups did show significant improvement at 3 and 6 months in various domains, including pain (VAS score for leg and back pain) and function (OCS and treadmill walking). CONCLUSION: These novel multimodal integrative treatments for LSS are both clinically safe and logistically feasible. Larger, adequately powered randomized controlled trials will be necessary to assess comparative efficacy and thoroughly analyze the cost-effectiveness of each treatment approach. CLINICAL TRIAL REGISTRATION NUMBER CRIS: KCT0001218. FAU - Kim, Kiok AU - Kim K AD - Department of Spine Center, Mokhuri Neck & Back Hospital, Seoul, South Korea. FAU - Shin, Kyung-Min AU - Shin KM AD - Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea. FAU - Hunt, Christy L AU - Hunt CL AD - Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN, USA. FAU - Wang, Zhen AU - Wang Z AD - Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA. FAU - Bauer, Brent A AU - Bauer BA AD - Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA. FAU - Kwon, Ojin AU - Kwon O AD - Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea. FAU - Lee, Jun-Hwan AU - Lee JH AD - Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea. AD - Korean Medicine Life Science, Campus of Korea Institute of Oriental Medicine, University of Science & Technology (UST), Daejeon, South Korea. FAU - Seo, Bok-Nam AU - Seo BN AD - Future Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea. FAU - Jung, So-Young AU - Jung SY AD - Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea. FAU - Youn, Yousuk AU - Youn Y AD - Department of Spine Center, Mokhuri Neck & Back Hospital, Seoul, South Korea. FAU - Lee, Sang Ho AU - Lee SH AD - Department of Spine Center, Mokhuri Neck & Back Hospital, Seoul, South Korea. FAU - Choi, Jung Chul AU - Choi JC AD - Department of Spine Center, Mokhuri Neck & Back Hospital, Seoul, South Korea. FAU - Jung, Jae Eun AU - Jung JE AD - Hongik Neurosurgery Hospital, Seongnam, South Korea. FAU - Kim, Jaehong AU - Kim J AD - Department of Spine Center, Mokhuri Neck & Back Hospital, Seoul, South Korea. FAU - Qu, Wenchun AU - Qu W AD - Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN, USA. AD - Department of Anesthesiology, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA, Eldrige.jason@mayo.edu. FAU - Kim, Tae-Hun AU - Kim TH AD - Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul, South Korea. FAU - Eldrige, Jason S AU - Eldrige JS AD - Department of Anesthesiology, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA, Eldrige.jason@mayo.edu. LA - eng PT - Journal Article DEP - 20190328 PL - New Zealand TA - J Pain Res JT - Journal of pain research JID - 101540514 PMC - PMC6445233 OTO - NOTNLM OT - Chuna OT - acupuncture OT - complementary and alternative medicine OT - epidural steroid injection OT - low back pain OT - lumbar spinal stenosis COIS- Disclosure The authors report no conflicts of interest in this work. EDAT- 2019/04/18 06:00 MHDA- 2019/04/18 06:01 PMCR- 2019/03/28 CRDT- 2019/04/18 06:00 PHST- 2019/04/18 06:00 [entrez] PHST- 2019/04/18 06:00 [pubmed] PHST- 2019/04/18 06:01 [medline] PHST- 2019/03/28 00:00 [pmc-release] AID - jpr-12-1103 [pii] AID - 10.2147/JPR.S173178 [doi] PST - epublish SO - J Pain Res. 2019 Mar 28;12:1103-1113. doi: 10.2147/JPR.S173178. eCollection 2019.