Pain
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The benefits of transcutaneous electrical nerve stimulation (TENS) for pain relief have not been reliably established, as most systematic reviews find poor methodological quality in many studies. The paradox within the evidence base for TENS is that despite identified sources of bias that may lead to an overestimation of treatment effects, no benefits for TENS can be clearly demonstrated. Conventional assessments of quality assume a single direction of bias, and little work has been undertaken examining other directions of bias. ⋯ We propose criteria for judging directions of bias in future studies of TENS that may be adapted to assess other trials in which implementation fidelity is important, such as other nonpharmacological interventions for pain. Poor implementation fidelity was identified as a significant source of bias in systematic reviews of TENS studies and might explain lack of consistent treatment effects of TENS in pain. Here, criteria for assessing methodology are proposed for use in designing future clinical trials of TENS.