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

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Department of Korean Rehabilitation Medicine, Pusan National University Korean Medicine Hospital, Yangsan 50612, Korea
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Department of Korean Medicine, School of Korean Medicine, Pusan National University, Yangsan 50612, Korea
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Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan 50612, Korea
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Department of Korean Rehabilitation Medicine, Kyung Hee University Korean Medicine Hospital at Gangdong, Seoul 05278, Korea
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Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul 06110, Korea
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Jaseng Hospital of Korean Medicine, Seoul 06110, Korea
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Mokhuri Neck & Back Hospital, Seoul 06272, Korea
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Korean Medicine Life Science, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon 34054, Korea
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Center for Comparative Effectiveness Research & Economic Evaluation in Korean Medicine, Pusan National University, Yangsan 50612, Korea
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2020, 9(1), 144; https://doi.org/10.3390/jcm9010144 (registering DOI)
Received: 2 December 2019 / Revised: 17 December 2019 / Accepted: 2 January 2020 / Published: 5 January 2020
(This article belongs to the Section Anesthesiology)
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. View Full-Text
Keywords: Chuna manipulative therapy; lower back pain; non-acute; pragmatic randomized controlled trial; comparative effectiveness research; safety Chuna manipulative therapy; lower back pain; non-acute; pragmatic randomized controlled trial; comparative effectiveness research; safety
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Park, S.-Y.; Hwang, E.-H.; Cho, J.-H.; Kim, K.-W.; Ha, I.-H.; Kim, M.-R.; Nam, K.; Lee, M.; Lee, J.-H.; Kim, N.; Shin, B.-C. Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial. J. Clin. Med. 2020, 9, 144.

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