Abstract
BackgroundLow 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.MethodsA 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.ResultsA 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.ConclusionsOur 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 registrationClinical Research Information Service (CRIS), KCT0001850. Registered on 12 March 2016.
Highlights
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
A number of studies, including systematic reviews and randomized controlled trials (RCTs), have shown that Spinal manual therapy (SMT) is as effective as other therapies, such as exercising and standard medical care or physiotherapy [7], and it is recommended that SMT be used for acute and chronic LBP [8,9,10]
There were 60 participants who responded to the recruitment materials, and 60 were eligible and allocated into three groups at four medical institutions, from 28 March 2016 to 19 September 2016
Summary
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. A total of 62% of people who experience LBP will develop chronic symptoms lasting longer than 1 year [3] For this reason, there are various standard treatments for managing back pain [4]; patients are often dissatisfied with these treatments [5]. A number of studies, including systematic reviews and randomized controlled trials (RCTs), have shown that SMT is as effective as other therapies, such as exercising and standard medical care or physiotherapy [7], and it is recommended that SMT be used for acute and chronic LBP [8,9,10]. Chuna manual therapy (CMT) is a sub-specialty that seamlessly brings together aspects of physiology, biodynamics of spine and joint motion, and the basic theory of movement dynamics. On the basis of this medical plan, the Korean Ministry of Health and Welfare started a national insurance pilot project covering CMT in 65 traditional Korean medical institutions in 2017
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