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.
This is the first cost-effectiveness analysis of Chuna manual therapy (CMT) plus usual Korean traditional medicine for traffic accident victims using a randomized controlled trial. A total of 132 participants were equally allocated to the intervention group receiving 6–11 sessions of CMT plus usual Korean traditional medicine care for three weeks or usual care including acupuncture, cupping, herbal medicine, moxibustion, and traditional physiotherapy at three hospitals. At 12 weeks, from a healthcare perspective, the intervention group had significantly higher costs (mean (SD), $778 (435) vs. $618 (318); difference, $160; 95% CI, $15 to $289; p = 0.005). From a societal perspective, total costs were insignificantly lower in the intervention group (mean (SD), $1077 (1081) vs. $1146 (1485); difference, $−69; 95% CI, $−568 to $377; p = 0.761). The intervention group dominated, with significantly higher QALYs gained at lower overall cost with a 72% chance of being cost-effective. From a societal perspective, the intervention was cost-saving for individuals who had neck pain after car accidents, although it was not cost-effective from the healthcare perspective ($40,038 per QALY gained). Findings support use of CMT as an integrated care treatment for whiplash from a societal perspective. Further studies with larger sample sizes are needed to determine cost-effectiveness in other cultural contexts.
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