Introduction. Back pain is one of the most common health problems in the industrialized world. Although using insoles appears to be common clinical practice, there is no hard data to support its effectiveness in prevention of low back pain. As a part of a Cochrane review, we conducted a literature search to determine the effectiveness of shoe insoles in the prevention and treatment of non-specific back pain compared to placebo, no intervention, or other interventions.

Materials and methods. We identified relevant clinical trials by searching The Cochrane Back Group Specialized Registry, The Cochrane Central Register, MED-LINE, EMBASE and CINAHL. All retrieved abstracts were blinded and were assessed by two independent investigators who decided on their inclusion. All these were again assessed by two different independent investigators, using the eleven items reflecting internal validity recommended by the Cochrane Back Review Group. A trial was considered to be of high quality if six or more out of eleven criteria were met.

Results. Our search found a total of 324 references. 8 papers, meeting the predetermined inclusion criteria, were retrieved of which six were found suitable for final evaluation. The clinical trials described in the papers included more than 2400 patients who used insoles for 3–5 months. Two articles with 199 patients demonstrated improvement in low back pain, while three larger studies found no difference between using insoles or no using insoles.

Discussion. There is no evidence for recommending the use of insoles for prevention of back pain. Additional high quality trials must be done to determine if they are effective in the treatment of low-back pain.