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

Musculoskelet Sci Pract. 2017 Jun;29:66-71. doi: 10.1016/j.msksp.2017.03.003. Epub 2017 Mar 14.

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.

Keywords: Adverse events; Chiropractic; Migraine; RCT; Randomized controlled trial; Side effects; Spinal manipulative therapy.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Female
  • Humans
  • Male
  • Manipulation, Chiropractic / adverse effects*
  • Manipulation, Chiropractic / methods*
  • Manipulation, Spinal / adverse effects*
  • Manipulation, Spinal / methods*
  • Middle Aged
  • Migraine Disorders / therapy*
  • Norway
  • Pain / etiology*
  • Placebo Effect
  • Single-Blind Method
  • Young Adult