Adverse events in a chiropractic spinal manipulative therapy single-blinded, placebo, randomized controlled trial for migraineurs

Aleksander Chaibi, Jūratė Šaltytė Benth, Peter J. Tuchin, Michael Bjørn Russell
2017 Musculoskeletal Science and Practice  
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
more » ... ineurs 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 3.9e10.2%) which presented a relative risk of 5.9 (CI 2.3e15.0). Conclusions: AEs were mild and transient, and severe or serious AEs were not observed. (P.J. Tuchin), m.b. russell@medisin.uio.no (M.B. Russell).
doi:10.1016/j.msksp.2017.03.003 pmid:28324697 fatcat:zl3oiy7hqbarlogrv77jddgv3u