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

• Published in: Current controlled trials in cardiovascular medicine Vol. 20; no. 1; p. 216
• Main Authors: Lim, Kyeong-Tae, Hwang, Eui-Hyoung, Cho, Jae-Heung, Jung, Jae-Young, Kim, Koh-Woon, Ha, In-Hyuk, Kim, Me-Riong, Nam, Kibong, Lee A, Min Ho, Lee, Jun-Hwan, Kim, Namkwen, Shin, Byung-Cheul
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 15-04-2019; BioMed Central; BMC
• Subjects: Adult; Analysis; Back pain; Back surgery; Care and treatment; Chronic illnesses; Chuna manual therapy; Clinical trials; Comparative Effectiveness Research; Female; Health insurance; Hospitals; Humans; Information services; Low back pain; Low Back Pain - therapy; Male; Manipulative therapy; Medicine; Middle Aged; Musculoskeletal Manipulations - adverse effects; Musculoskeletal Manipulations - methods; Nonsteroidal anti-inflammatory drugs; Oral administration; Orthopedic surgery; Pain management; Performance evaluation; Physical therapy; Pilot Projects; Pilot study; Questionnaires; Randomized controlled trial; Range of Motion, Articular; Comparative effectiveness research; Pilot study; Chuna manual therapy; Randomized controlled trial; Low back pain
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-019-3302-y

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.
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.
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.
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.
Clinical Research Information Service (CRIS), KCT0001850 . Registered on 12 March 2016.