Background Unlike pharmacological randomized controlled trials (RCTs), manual-therapy RCTs do not always report adverse events (AEs). The few manual-therapy RCTs that provide information on AEs are frequently without details, such as the type and-, severity of the AE and reason for withdrawal. Objective To prospectively report all AEs in a chiropractic spinal manipulative therapy (CSMT) RCT. Design A prospective 3-armed, single-blinded, placebo, RCT. Methods Seventy migraineurs were randomized to the CSMT or a placebo, with 12 intervention sessions over three months. The recommendations by CONSORT and the International Headache Society's Task Force on AEs in migraine RCTs were followed. A standardized reporting scheme designed for pharmacological RCTs was used, and the AEs were described as frequencies and percentages within each group. The 95% confidence intervals (CIs) for the percentages (absolute risk) of AEs in each group were calculated when possible. Attributable risk (%) and relative risk were calculated with the corresponding 95% CIs. Results AEs were assessed in 703 sessions, with 355 in the CSMT group and 348 in the placebo group. Local tenderness was the most common AE, reported by 11.3% and 6.9% of the CSMT group and the placebo group, respectively, and tiredness on the intervention day was reported by 8.5% and 1.4% of CSMT group and the placebo group, respectively. The highest attributable risk was for tiredness on the treatment day, 7.0% (CI 3.9–10.2%) which presented a relative risk of 5.9 (CI 2.3–15.0). Conclusions AEs were mild and transient, and severe or serious AEs were not observed.
Bibliographical noteErratum can be found in Musculoskeletal Science and Practice Volume 31 (October 2017), 21, https://doi.org/10.1016/j.msksp.2017.06.001.
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- adverse events
- randomized controlled trial
- side effects
- spinal manipulative therapy