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Published in: Trials 1/2019

Open Access 01-12-2019 | Leg Pain | Research

Comparative effectiveness of Chuna manual therapy versus conventional usual care for non-acute low back pain: a pilot randomized controlled trial

Authors: Kyeong-Tae Lim, Eui-Hyoung Hwang, Jae-Heung Cho, Jae-Young Jung, Koh-Woon Kim, In-Hyuk Ha, Me-riong Kim, Kibong Nam, Min ho Lee A, Jun-Hwan Lee, Namkwen Kim, Byung-Cheul Shin

Published in: Trials | Issue 1/2019

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Abstract

Background

Low back pain (LBP) is common, with a lifetime prevalence of 80%, and as such it places substantial social and economic burden on individuals and society. Chuna manual therapy (CMT) combines aspects of physiology, biodynamics of spine and joint motion, and basic theory of movement dynamics. This study aimed to test the comparative effectiveness and safety of CMT for non-acute LBP.

Methods

A three-arm, multicenter, pragmatic, randomized controlled pilot trial was conducted from 28 March 2016 to 19 September 2016, at four medical institutions. A total of 60 patients were randomly allocated to the CMT group (n = 20), usual care (UC) group (n = 20), or combined treatment (CMT + UC) group (n = 20), and received the relevant treatments for 6 weeks. The primary outcome was a numeric rating scale (NRS) representation of LBP intensity, while secondary outcomes included NRS of leg pain, Oswestry disability index (ODI), Patient Global Impression of Change (PGIC), the EuroQol-5 dimensions (EQ-5D), lumbar range of motion, and safety.

Results

A total of 60 patients were included in the intention-to-treat analysis and 55 patients (CMT, 18; UC, 18; CMT + UC, 19) were included in the per-protocol analysis (drop-out rate 5.3%). Over the treatment period there were significant differences in the NRS score for LBP (CMT mean − 3.28 (95% CI − 4.08, − 2.47); UC − 1.95 (− 2.82, − 1.08); CMT + UC − 1.75 (− 2.70, − 0.80), P < 0.01) and the ODI scores in each group (CMT − 12.29 (− 16.86, − 7.72); UC − 10.34 (− 14.63, − 6.06); CMT + UC − 9.27 (− 14.28, − 4.26), P < 0.01). The changes in other secondary outcomes did not significantly differ among the three groups. Sixteen minor-to-moderate safety concerns were reported.

Conclusions

Our results suggest that CMT has comparative efficacy for non-acute LBP and is generally safe. As this was a preliminary study, a well-powered (over 192 participants) two-arm (CMT versus UC) verification trial will be performed to assess the generalizability of these results.

Trial registration

Clinical Research Information Service (CRIS), KCT0001850. Registered on 12 March 2016.
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Metadata
Title
Comparative effectiveness of Chuna manual therapy versus conventional usual care for non-acute low back pain: a pilot randomized controlled trial
Authors
Kyeong-Tae Lim
Eui-Hyoung Hwang
Jae-Heung Cho
Jae-Young Jung
Koh-Woon Kim
In-Hyuk Ha
Me-riong Kim
Kibong Nam
Min ho Lee A
Jun-Hwan Lee
Namkwen Kim
Byung-Cheul Shin
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3302-y

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