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Outcomes of Usual Chiropractic Harm (OUCH) randomised controlled trial of adverse events [with consumer summary]
Walker BF, Hebert JJ, Stomski NJ, Clarke BR, Bowden RS, Losco B, French SD
Spine 2013 Sep 15;38(20):1723-1729
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

STUDY DESIGN: Blinded parallel group randomised controlled. OBJECTIVE: Establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. SUMMARY OF BACKGROUND DATA: Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, as a result of design limitations in previous studies, particularly the lack of sham-controlled randomised trials, understanding of these adverse events and their relation with chiropractic treatment, is suboptimal. METHODS: We conducted a trial to examine the occurrence of adverse events resulting from chiropractic treatment. It was conducted across 12 chiropractic clinics in Perth, Western Australia. The participants comprised 183 adults, aged 20 to 85, with spinal pain. Ninety two participants received individualized care consistent with the chiropractors' usual treatment approach; 91 participants received a sham intervention. Each participant received two treatments. RESULTS: Completed adverse questionnaires were returned by 94.5% of the participants after appointment one and 91.3% after appointment two. Thirty three per cent of the sham group and 42% of the usual care group reported at least one adverse event. Common adverse events were increased pain (sham 29%; usual care 36%), muscle stiffness (sham 29%; usual care 37%), headache (sham 17%; usual care 9%). The relative risk was not significant for either adverse event occurrence (RR 1.24; 95% CI 0.85 to 1.81); occurrence of severe adverse events (RR 1.9; 95% CI 0.98 to 3.99); adverse event onset (RR 0.16; 95% CI 0.02 to 1.34); or adverse event duration (RR 1.13; 95% CI 0.59 to 2.18). No serious adverse events were reported. CONCLUSIONS: A substantial proportion of adverse events following chiropractic treatment may result from natural history variation and non-specific effects.
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