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

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.

Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial

“…The details of the research process are summarized in Table S1 and Figure 1 shows a short guide of the research process. Further information is available at the clinical trial registration site Clinical Research Information Service (CRIS, https://cris.nih.go.kr; KCT0002329) and in the previous pilot study [11]. J. Clin.…”

“…Based on previous literature and our pilot study, the following assumptions were made when determining our sample size: (1) level of significance α = 0.05, (2) type 2 error β = 0.2, with test power set at 80%, and (3) reference to outcomes from a prior pilot trial [11] which used the NRS as the primary measure. Mean difference and standard deviation (SD) between the two groups were respectively specified as 1.5 [12] and 3.3 based on an intention-to-treat (ITT) analysis by a statistician, and (4) estimated compliance was set as 80%.…”

“…Cases receiving injections such as steroid nerve blocks were monitored and regarded as dropouts. Details on the Chuna techniques and UC used in the previous trial and detailed instruction materials utilized in this subsequent full-scale study can be found in the pilot protocol [13], and pilot trial [11].…”

“…Thus, the Chuna Research Network (CRN), consisting of two universities, two spine-specialty hospitals, and the Korea Institute of Oriental medicine (KIOM), determined a sufficiently powered sample (n = 194) through a pilot trial [11]. We conducted a full-scale pragmatic, confirmative RCT evaluating the comparative effectiveness and safety of CMT for non-acute LBP including an economic evaluation.…”

A Facial Chuna Manual Therapy for Peripheral Facial Nerve Palsy

“…It is based on traditional Korean medicine theory, which encompasses concepts such as meridian theory and anatomy based on radiology. It is a technique that uses the practitioner's hand, and other parts of the body, or equipment to adjust the body's imbalance [10]. A variety of manual therapies are currently used to treat facial palsy in patients, including patients who have suffered a stroke.…”