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Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial

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 integrati...

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Autores principales: Kim, Kiok, Shin, Kyung-Min, Hunt, Christy L, Wang, Zhen, Bauer, Brent A, Kwon, Ojin, Lee, Jun-Hwan, Seo, Bok-Nam, Jung, So-Young, Youn, Yousuk, Lee, Sang Ho, Choi, Jung Chul, Jung, Jae Eun, Kim, Jaehong, Qu, Wenchun, Kim, Tae-Hun, Eldrige, Jason S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6445233/
https://www.ncbi.nlm.nih.gov/pubmed/30992679
http://dx.doi.org/10.2147/JPR.S173178
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author Kim, Kiok
Shin, Kyung-Min
Hunt, Christy L
Wang, Zhen
Bauer, Brent A
Kwon, Ojin
Lee, Jun-Hwan
Seo, Bok-Nam
Jung, So-Young
Youn, Yousuk
Lee, Sang Ho
Choi, Jung Chul
Jung, Jae Eun
Kim, Jaehong
Qu, Wenchun
Kim, Tae-Hun
Eldrige, Jason S
author_facet Kim, Kiok
Shin, Kyung-Min
Hunt, Christy L
Wang, Zhen
Bauer, Brent A
Kwon, Ojin
Lee, Jun-Hwan
Seo, Bok-Nam
Jung, So-Young
Youn, Yousuk
Lee, Sang Ho
Choi, Jung Chul
Jung, Jae Eun
Kim, Jaehong
Qu, Wenchun
Kim, Tae-Hun
Eldrige, Jason S
author_sort Kim, Kiok
collection PubMed
description 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.
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spelling pubmed-64452332019-04-16 Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial Kim, Kiok Shin, Kyung-Min Hunt, Christy L Wang, Zhen Bauer, Brent A Kwon, Ojin Lee, Jun-Hwan Seo, Bok-Nam Jung, So-Young Youn, Yousuk Lee, Sang Ho Choi, Jung Chul Jung, Jae Eun Kim, Jaehong Qu, Wenchun Kim, Tae-Hun Eldrige, Jason S J Pain Res Original Research 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. Dove Medical Press 2019-03-28 /pmc/articles/PMC6445233/ /pubmed/30992679 http://dx.doi.org/10.2147/JPR.S173178 Text en © 2019 Kim et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Kim, Kiok
Shin, Kyung-Min
Hunt, Christy L
Wang, Zhen
Bauer, Brent A
Kwon, Ojin
Lee, Jun-Hwan
Seo, Bok-Nam
Jung, So-Young
Youn, Yousuk
Lee, Sang Ho
Choi, Jung Chul
Jung, Jae Eun
Kim, Jaehong
Qu, Wenchun
Kim, Tae-Hun
Eldrige, Jason S
Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial
title Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial
title_full Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial
title_fullStr Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial
title_full_unstemmed Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial
title_short Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial
title_sort nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6445233/
https://www.ncbi.nlm.nih.gov/pubmed/30992679
http://dx.doi.org/10.2147/JPR.S173178
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