Research design considerations for randomized controlled trials of spinal cord stimulation for pain: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials/Institute of Neuromodulation/International Neuromodulation Society recommendations

Abstract

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Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial

“…Patient selection could have been further strengthened by the inclusion of neuropathic pain specific screening questionnaires. The development and use of a true sham intervention with some perceivable but in-efficient stimulation parameters is a further strength—the lack of credible sham intervention has previously been noted as a limitation in neuromodulation trials [ 41 , 42 ]. The study achieved a high level of patient adherence resulting in high data quality reducing uncertainty, and active and comparator groups were well balanced.…”

Patient Selection for Spinal Cord Stimulation in Treatment of Pain: Sequential Decision-Making Model — A Narrative Review

“… 66 Another bias that could potentially occur in clinical practice is baseline-score inflation to fulfill the criteria for a successful screening trial. 67 …”

If the Doors of Perception Were Cleansed, Would Chronic Pain be Relieved? Evaluating the Benefits and Risks of Psychedelics

“…This not only involves patient blinding (psychedelic-na€ ıve patients may be easier to blind) and blinding of all study staff, but also blinding of all study materials to the greatest extent possible. 2,43,44,78,96 Depending on the specific trial objectives and methods, information about hypotheses, research design, allocation ratio, eligibility criteria, and other study characteristics not involving safety may be withheld from materials available to patients and staff, including the consent form, protocol, advertisements, media posts/articles, and clinicaltrials.gov. The appropriateness of using such procedures to protect blinding integrity is supported by the imperative to avoid harms resulting from uninformative clinical trials.…”

“…Guidelines to improve rigor and reproducibility are available for pain 55,83 and psychedelic 106 trials, and it has been suggested recently that publications should describe any specific procedures used to address expectations and blinding integrity. 78,96 Conclusions: From Clinical Trials to Clinical Practice Concerns have been raised that the current renaissance in psychedelic research could go "off the rails," as happened to an earlier generation of psychedelic research in the late 1960s. 142 One important issue involves scale, that is, the training of large numbers of facilitators and therapists to ensure quality practice and patient safety, not only for large RCTs but also for implementation of approved treatments in the community.…”