Bias in neuromodulation studies on chronic pain.
While bias is an integral part of human behavior, bias in clinical research studies may lead to erroneous study conclusions and potentially negative consequences affecting medical care. Bias may influence multiple stages of clinical research and is remarkably prevalent in industry-sponsored studies. Particularly challenging are neuromodulation studies involving patients with chronic pain, whereby industry sponsorship, physicians' conflicts of interest, and patient factors collide to create a highly complex medium that renders clinical research design and interpretation very intricate. This narrative review aims to explore the various biases that complicate clinical neuromodulation studies on chronic pain and potential bias mitigation strategies. Recent studies have highlighted the influence of industry sponsorship of clinical research and the various types of bias that may occur in designing studies. Biases within device-related industry-sponsored studies, including neuromodulation, have come to the forefront, as have recommendations put forward by societal workgroups on best practices in designing and implementing clinical neuromodulation studies. This review critically examines the various forms of bias in clinical research, and in particular in relation to neuromodulation studies with a focus on spinal cord stimulation, and on potential means to mitigate such bias.
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Chronic pain is a global health problem with a significant patient and socioeconomic burden. The technology of spinal cord stimulation (SCS), an efficient strategy for managing persistent pain, has undergone significant development in the previous couple of decades. The purpose of this paper is to review the development of SCS techniques, compare the efficacy of different SCS modalities, and explore future research directions. The article reviewed the development of SCS, including traditional tonic SCS, high-frequency SCS, burst SCS, and closed-loop SCS. Clinical trial and research data analysis were used to assess the safety and effectiveness of the different SCS modalities in the treatment of chronic pain. The study showed that high-frequency SCS and burst SCS were effective in relieving pain without producing paresthesia compared with conventional SCS. Closed-loop SCS provides a more personalized treatment plan by modulating stimulation through real-time feedback. However, the application of SCS still faces technical challenges, such as electrode displacement and equipment malfunction. SCS technology shows great potential in chronic pain management. With technological advances, SCS is expected to provide more effective and personalized treatment options for chronic pain patients. Subsequent investigations ought to concentrate on enhancing device stability, mitigating issues, and investigating astute and customized therapeutic alternatives.
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