OBJECTIVE: To evaluate the efficacy of acupuncture in the treatment of fibromyalgia, considering the immediate response of the visual analogue pain scale (VAS) as its primary outcome. METHODS: Randomized, controlled, double-blind study including 36 patients with fibromyalgia (ACR 1990) selected from the outpatient rheumatology clinic, Santa Casa de Misericordia, Ponta Grossa, PR. Twenty-one patients underwent an acupuncture session, under the principles of the traditional Chinese medicine, and 15 patients underwent a placebo procedure (sham acupuncture). For pain assessment, the subjects completed a visual analogue scale (VAS) before and immediately after the proposed procedure. The mean change in VAS was compared among groups. RESULTS: The variation between the final and initial VAS values was -4.36 +/- 3.23 (p = 0.0001) in the treatment group and -1.70 +/- 1.55 in the control group (p = 0.06). The difference in terms of amplitude of variation of VAS (initial minus final VAS) among groups favored the actual procedure (p = 0.005). The effect size (ES) for the treatment group was d = 1.7, which is considered a large effect. Although small, the statistical power of the sample for these results was very relevant (94.8%). CONCLUSION: Acupuncture has proven effective in the immediate pain reduction in patients with fibromyalgia, with a quite significant effect size.

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