Cargando…
Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial
Current evidence on the effectiveness and safety of Chuna manipulative therapy (CMT) for managing non-acute lower back pain (LBP) is insufficient. We investigated the comparative effectiveness and safety of CMT, a Korean style of manipulation, plus usual care (UC) compared to UC alone for non-acute...
Autores principales: | , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7019562/ https://www.ncbi.nlm.nih.gov/pubmed/31948083 http://dx.doi.org/10.3390/jcm9010144 |
_version_ | 1783497548084805632 |
---|---|
author | Park, Sun-Young Hwang, Eui-Hyoung Cho, Jae-Heung Kim, Koh-Woon Ha, In-Hyuk Kim, Me-riong Nam, Kibong Lee, Min ho Lee, Jun-Hwan Kim, Namkwen Shin, Byung-Cheul |
author_facet | Park, Sun-Young Hwang, Eui-Hyoung Cho, Jae-Heung Kim, Koh-Woon Ha, In-Hyuk Kim, Me-riong Nam, Kibong Lee, Min ho Lee, Jun-Hwan Kim, Namkwen Shin, Byung-Cheul |
author_sort | Park, Sun-Young |
collection | PubMed |
description | Current evidence on the effectiveness and safety of Chuna manipulative therapy (CMT) for managing non-acute lower back pain (LBP) is insufficient. We investigated the comparative effectiveness and safety of CMT, a Korean style of manipulation, plus usual care (UC) compared to UC alone for non-acute LBP. We conducted a parallel, two-armed, multi-centered, assessor blinded, pragmatic, randomized controlled trial at four major Korean medical hospitals. Overall, 194 patients were randomly allocated to either CMT plus UC (n = 97) or UC alone (n = 97), for six weeks of treatment and six months follow-up. The primary outcome was measured using the numerical rating scale (NRS) of LBP intensity at 7 weeks. Secondary outcomes included NRS of leg pain, Oswestry Disability Index (ODI) for functional disability, patient global impression of change (PGIC) scale, and safety. A total of 194 patients were included in the intention-to-treat analysis, and 174 patients provided complete data for the primary outcome. At 7 weeks, clinically significant differences between groups were observed in the NRS of LBP (CMT + UC: −3.02 ± 1.72, UC: −1.36 ± 1.75, p < 0.001), ODI scores (CMT + UC: −5.65 ± 4.29, UC: −3.72 ± 4.63, p = 0.003), NRS of leg pain (CMT + UC: −2.00 ± 2.33, UC: −0.44 ± 1.86, p < 0.0001), and PGIC (CMT + UC: −0.28 ± 0.85, UC: 0.01 ± 0.66, p = 0.0119). Mild to moderate safety concerns were reported in 21 subjects. CMT plus UC showed higher effectiveness compared to UC alone in patients with non-acute LBP in reducing LBP and leg pain and in improving function with good safety results using a powered sample size and including mid-term follow-up. |
format | Online Article Text |
id | pubmed-7019562 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-70195622020-03-09 Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial Park, Sun-Young Hwang, Eui-Hyoung Cho, Jae-Heung Kim, Koh-Woon Ha, In-Hyuk Kim, Me-riong Nam, Kibong Lee, Min ho Lee, Jun-Hwan Kim, Namkwen Shin, Byung-Cheul J Clin Med Article Current evidence on the effectiveness and safety of Chuna manipulative therapy (CMT) for managing non-acute lower back pain (LBP) is insufficient. We investigated the comparative effectiveness and safety of CMT, a Korean style of manipulation, plus usual care (UC) compared to UC alone for non-acute LBP. We conducted a parallel, two-armed, multi-centered, assessor blinded, pragmatic, randomized controlled trial at four major Korean medical hospitals. Overall, 194 patients were randomly allocated to either CMT plus UC (n = 97) or UC alone (n = 97), for six weeks of treatment and six months follow-up. The primary outcome was measured using the numerical rating scale (NRS) of LBP intensity at 7 weeks. Secondary outcomes included NRS of leg pain, Oswestry Disability Index (ODI) for functional disability, patient global impression of change (PGIC) scale, and safety. A total of 194 patients were included in the intention-to-treat analysis, and 174 patients provided complete data for the primary outcome. At 7 weeks, clinically significant differences between groups were observed in the NRS of LBP (CMT + UC: −3.02 ± 1.72, UC: −1.36 ± 1.75, p < 0.001), ODI scores (CMT + UC: −5.65 ± 4.29, UC: −3.72 ± 4.63, p = 0.003), NRS of leg pain (CMT + UC: −2.00 ± 2.33, UC: −0.44 ± 1.86, p < 0.0001), and PGIC (CMT + UC: −0.28 ± 0.85, UC: 0.01 ± 0.66, p = 0.0119). Mild to moderate safety concerns were reported in 21 subjects. CMT plus UC showed higher effectiveness compared to UC alone in patients with non-acute LBP in reducing LBP and leg pain and in improving function with good safety results using a powered sample size and including mid-term follow-up. MDPI 2020-01-05 /pmc/articles/PMC7019562/ /pubmed/31948083 http://dx.doi.org/10.3390/jcm9010144 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Park, Sun-Young Hwang, Eui-Hyoung Cho, Jae-Heung Kim, Koh-Woon Ha, In-Hyuk Kim, Me-riong Nam, Kibong Lee, Min ho Lee, Jun-Hwan Kim, Namkwen Shin, Byung-Cheul Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial |
title | Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial |
title_full | Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial |
title_fullStr | Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial |
title_full_unstemmed | Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial |
title_short | Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial |
title_sort | comparative effectiveness of chuna manipulative therapy for non-acute lower back pain: a multi-center, pragmatic, randomized controlled trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7019562/ https://www.ncbi.nlm.nih.gov/pubmed/31948083 http://dx.doi.org/10.3390/jcm9010144 |
work_keys_str_mv | AT parksunyoung comparativeeffectivenessofchunamanipulativetherapyfornonacutelowerbackpainamulticenterpragmaticrandomizedcontrolledtrial AT hwangeuihyoung comparativeeffectivenessofchunamanipulativetherapyfornonacutelowerbackpainamulticenterpragmaticrandomizedcontrolledtrial AT chojaeheung comparativeeffectivenessofchunamanipulativetherapyfornonacutelowerbackpainamulticenterpragmaticrandomizedcontrolledtrial AT kimkohwoon comparativeeffectivenessofchunamanipulativetherapyfornonacutelowerbackpainamulticenterpragmaticrandomizedcontrolledtrial AT hainhyuk comparativeeffectivenessofchunamanipulativetherapyfornonacutelowerbackpainamulticenterpragmaticrandomizedcontrolledtrial AT kimmeriong comparativeeffectivenessofchunamanipulativetherapyfornonacutelowerbackpainamulticenterpragmaticrandomizedcontrolledtrial AT namkibong comparativeeffectivenessofchunamanipulativetherapyfornonacutelowerbackpainamulticenterpragmaticrandomizedcontrolledtrial AT leeminho comparativeeffectivenessofchunamanipulativetherapyfornonacutelowerbackpainamulticenterpragmaticrandomizedcontrolledtrial AT leejunhwan comparativeeffectivenessofchunamanipulativetherapyfornonacutelowerbackpainamulticenterpragmaticrandomizedcontrolledtrial AT kimnamkwen comparativeeffectivenessofchunamanipulativetherapyfornonacutelowerbackpainamulticenterpragmaticrandomizedcontrolledtrial AT shinbyungcheul comparativeeffectivenessofchunamanipulativetherapyfornonacutelowerbackpainamulticenterpragmaticrandomizedcontrolledtrial |