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Systematic review of randomized clinical trials.To assess the efficacy of spinal manipulation for patients with low back pain.The management of low back pain remains controversial. Spinal manipulation is a widely used treatment option for low back pain. Recently issued clinical guidelines suggest that spinal manipulation may be effective for patients with acute low back pain.A computer-aided search for published papers was conducted, and the methods of the studies identified were assessed. Scores were assigned for quality of methods (based on four main categories: study population, interventions, measurement of effect, and data presentation and analysis), the conclusion of authors regarding spinal manipulation, and the results based on the main outcome measure.Thirty-six randomized clinical trials comparing spinal manipulation with other treatments were identified. The highest score of a trial was 60 points (maximum score was set at 100 points), indicating that most were of poor quality. Nineteen studies (53%) showed favorable results for manipulation. In addition, five studies (14%) reported positive results in one or more subgroups only. Among the five studies with 50-60 points, three were positive, and two were positive only for a subgroup of the study population. Eleven trials compared manipulation with some placebo therapy, with inconsistent results. There appeared to be no clear relation between the methodologic score and the overall outcome of the studies. Twelve trials included patients with acute low back pain only. Of these, five reported positive results, four reported negative results, and three reported positive results in a subgroup of the study population only. There were eight trials comparing manipulation with other conservative treatment modalities, focusing on patients with subacute or chronic low back pain. Of these, five reported positive results, two reported negative results, and in one study no conclusion was presented. There were only 16 studies that included an effect measurement of at least 3 months. In only six of these do the authors report positive effects of manipulation.The efficacy of spinal manipulation for patients with acute or chronic low back pain has not been demonstrated with sound randomized clinical trials. There certainly are indications that manipulation might be effective in some subgroups of patients with low back pain. These impressions justify additional research efforts on this topic. Methodologic quality remains a critical aspect that should be dealt with in future studies.