To establish whether there is evidence for or against the efficacy of needling as a treatment approach for myofascial trigger point pain. PubMed, Ovid MEDLINE, Ovid EMBASE, the Cochrane Library, AMED, and CISCOM databases, searched from inception to July 999. Randomized, controlled trials in which some form of needling therapy was used to treat myofascial pain. Two reviewers independently extracted data concerning trial methods, quality, and outcomes. Twenty-three papers were included. No trials were of sufficient quality or design to test the efficacy of any needling technique beyond placebo in the treatment of myofascial pain. Eight of the 10 trials comparing injection of different substances and all 7 higher quality trials found that the effect was independent of the injected substance. All 3 trials that compared dry needling with injection found no difference in effect. Direct needling of myofascial trigger points appears to be an effective treatment, but the hypothesis that needling therapies have efficacy beyond placebo is neither supported nor refuted by the evidence from clinical trials. Any effect of these therapies is likely because of the needle or placebo rather than the injection of either saline or active drug. Controlled trials are needed to investigate whether needling has an effect beyond placebo on myofascial trigger point pain. Copyright 2001 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation