Sham controls in device trials for chronic pain – tricky in practice-a review article

BACKGROUND: Chronic pain affects one in four people and this figure is likely to increase further in line with an ageing population. Efforts to evaluate nonpharmacological interventions to support this patient population have become a priority for pain research. For device trials, the use of a sham control can add to the scientific validity and quality of a study. However, only a small proportion of pain trials include a sham control, and many are of poor quality. To facilitate the conduct of high-quality trials there is a need for a comprehensive overview to guide researchers within this area. The objective of this review was to synthesise the published data to address this need. METHODS: We identified studies that considered the evaluation, design, and conduct of sham-controlled trials in chronic pain by searching MEDLINE, CINAHL and Science Direct to November 2022. Studies that included sufficient content to inform the conduct/design of future research were included. An inductive thematic analysis approach was used to identify themes that require consideration when conducting sham-controlled trials. These are presented as a narrative review. RESULTS: 37 articles were included. Identified themes related to the type of sham device, sham design, bias, study population and ethics. CONCLUSIONS: To conduct good quality research the challenges surrounding the use of sham interventions need to be better considered. We highlight salient issues and provide recommendations for the conduct and reporting of sham-controlled device trials in chronic pain