Safety of Chuna Manipulation Therapy in 289,953 Patients with Musculoskeletal Disorders: A Retrospective Study

Abstract

Studies have reported that mild adverse events (AEs) are common after manual therapy and that there is a risk of serious injury. We aimed to assess the safety of Chuna manipulation therapy (CMT), a traditional manual Korean therapy, by analysing AEs in patients who underwent this treatment. Patients who received at least one session of CMT between December 2009 and March 2019 at 14 Korean medicine hospitals were included. Electronic patient charts and internal audit data obtained from situation report logs were retrospectively analysed. All data were reviewed by two researchers. The inter-rater agreement was assessed using the Cohen’s kappa coefficient, and reliability analysis among hospitals was assessed using Cronbach’s Alpha coefficient. In total, 2,682,258 CMT procedures were performed in 289,953 patients during the study period. There were 50 AEs, including worsened pain (n = 29), rib fracture (n = 11), falls during treatment (n = 6), chest pain (n = 2), dizziness (n = 1), and unpleasant feeling (n = 1). The incidence of mild to moderate AEs was 1.83 (95% confidence interval [CI] 1.36–2.39) per 100,000 treatment sessions, and that of severe AEs was 0.04 (95% CI 0.00–0.16) per 100,000 treatment sessions. Thus, AEs of any level of severity were very rare after CMT. Moreover, there were no instances of carotid artery dissection or spinal cord injury, which are the most severe AEs associated with manual therapy in other countries.

A retrospective analysis of the incidence of severe adverse events among recipients of chiropractic spinal manipulative therapy

“…A rib fracture is also a recognized cause for malpractice litigation claims against chiropractors and, in one study, accounted for two of 48 claims in the United States (i.e., 4.2%) 46 . In the current study, the incidence of rib fractures was comparable to that identified in a previous study examining Chuna manipulation (i.e., 0.41; 95% CI 0.21, 0.70) 5 . However, in the current study, both cases of rib fracture were recorded as grade 3 (severe) AEs, whereas in the previous study, they were recorded as grade 2.…”

“…A sample size of 7,299 for our primary objective was calculated using data from a similar study that identified 50 AEs per 2,682,258 manipulations, yielding an incidence of 0.000019 for AEs 5 . The formula n = [Z2P(1 − P)]/(d2) was utilized wherein Z equals the Z statistic for the level of confidence of 95% (i.e., 1.96), P is the probability of 0.000019, and d is the required precision, of 0.0001 or 0.01% 39 .…”

“…In comparison, many chart review or survey studies examining AEs related to chiropractic SMT have had a smaller sample size (i.e., n ≤ 50,276 SMT treatments) and did not identify any severe AEs [12][13][14][15]30,31,43 . One recent large study, which examined the incidence of AEs related to Chuna manipulation, reported an incidence of severe AEs of 0.04 (95% CI 0.00, 0.16) per 100,000 treatment sessions in a sample of 2,682,258 manipulations 5 .…”

“…However, AEs that occurred in relation to a non-SMT therapy on a treatment day that SMT was not provided were not considered SMT-related. A similar conservative approach to including AEs among patients receiving contemporaneous multimodal care was also utilized in a similar study 5 . For example, if a patient received thoracic SMT in addition to a back massage provided by a mechanical device during the same date of care, then developed a vertebral fracture, this was considered a potential SMT-related AE.…”

“…While various schemes have been used previously to grade the severity of AEs in relation to SMT 4 , the current study utilized the Common Terminology Criteria for Adverse Events (CTCAE). Previous authors have utilized this system to grade the severity of AEs related to SMT 5,[32][33][34] . CTCAE is becoming a standard measurement system and is used in other fields, such as cancer therapies 35 , pharmacology 36 , and surgery 37 .…”