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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...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2019
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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. |
format | Online Article Text |
id | pubmed-6445233 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
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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