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

Abstract

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.

Pragmatic trials of pain therapies: a systematic review of methods

“…Where allowed, concomitant treatments were unrestricted in 30 trials (68% of applicable cases) and 6 trials permitted any concomitant treatment other than those akin or similar to the study interventions. Some trials excluded individual unrelated interventions, such as injections and surgery, 88 injections alone, 87 physiotherapy, 16 tricyclic antidepressants, 5 or pain medication (not further specified). 59 , 102 Only one drug trial made specific allowances for medications and dosages, including some of the same class as study interventions and opioids.…”

“…Similarly, common medications were a reason for noneligibility in 7 studies (12%). Once enrolled, patients were advised not to seek additional care outside the trial in 9 studies (16%) 19 , 23 , 35 , 49 , 88 , 93 , 102 , 111 , 127 ; the report was unclear on that point in 19 instances.…”

Effect of remifentanil-based fast-track anesthesia on postoperative analgesia and sedation in adult patients undergoing transthoracic device closure of ventricular septal defect

“…An NRS allowed a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where "0" meant "no pain" and "10" meant pain as "bad as it could be," and the patient circled a number to represent the degree of pain. We regarded 0 as painless, 1 to 3 as mild pain, 4 to 6 as moderate pain, and 7 to 10 as severe pain [11,12].…”

Cost-Utility Analysis of Chuna Manual Therapy and Usual Care for Chronic Neck Pain: A Multicenter Pragmatic Randomized Controlled Trial

“…Chuna manual therapy for the treatment of musculoskeletal disorders has been covered by the South Korean national health insurance since April 2019. Subsequently, it became possible to examine the use of manual therapy for musculoskeletal disorders to determine its efficacy and cost-effectiveness ( 12 , 13 ). A recent study demonstrated that Chuna manual therapy (Chuna) was more effective in relieving pain and improving function and quality of life than usual care (i.e., Western medicine, such as physical therapy) ( 11 ).…”