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A systematic review of randomized controlled trials.To determine the effectiveness of shoe insoles in the prevention and treatment of nonspecific back pain compared with placebo, no intervention, or other interventions.There is lack of theoretical and clinical knowledge of the use of insoles for prevention or treatment of back pain.We searched electronic databases from inception to October 2008. We reviewed reference lists in review articles, guidelines, and in the included trials; conducted citation tracking; and contacted individuals with expertise in this domain. One review author conducted the searches and blinded the retrieved references for authors, institution, and journal. Two review authors independently selected the relevant articles. Two different review authors independently assessed the methodological quality and clinical relevance and extracted the data from each trial using the criteria recommended by the Cochrane Back Review Group.Six randomized controlled trials met inclusion criteria: 3 examined prevention of back pain (2061 participants) and 3 examined mixed populations (256 participants) without being clear whether they were aimed at primary or secondary prevention or treatment. No treatment trials were found. There is strong evidence that the use of insoles does not prevent back pain. There is limited evidence that insoles alleviate back pain or adversely shift the pain to the lower extremities.There is strong evidence that insoles are not effective for the prevention of back pain. The currentevidence on insoles as treatment for low back pain does not allow any conclusions.