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

*Corresponding author for this work

Research output: Contribution to journalArticle

7 Citations (Scopus)
15 Downloads (Pure)

Abstract

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.

Original languageEnglish
Pages (from-to)66-71
Number of pages6
JournalMusculoskeletal Science and Practice
Volume29
DOIs
Publication statusPublished - 1 Jun 2017

Bibliographical note

Erratum can be found in Musculoskeletal Science and Practice Volume 31 (October 2017), 21, https://doi.org/10.1016/j.msksp.2017.06.001.

Copyright the Author(s) 2017. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • adverse events
  • chiropractic
  • migraine
  • randomized controlled trial
  • RCT
  • side effects
  • spinal manipulative therapy

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