Trial reportPain medicine (Malden, Mass.)2025
Personalized outcomes in neuropathic pain: a clinical relevance and assay sensitivity analysis from a randomized controlled trial.
Trial report in Pain medicine (Malden, Mass.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Real-World Evaluation of Botulinum Toxin A in Focal Peripheral Neuropathic Pain: Longitudinal Outcomes.European journal of neurology · 2025Observational
- Therapeutic Potential of 7,8-Dimethoxycoumarin in Tumor Necrosis Factor-Alpha-Induced Trigeminal Neuralgia in a Rat Model.Current issues in molecular biology · 2025Article
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
objectiveTo explore the clinical relevance and assay sensitivity of using personalized outcomes using data from a randomized clinical trial (RCT) in people with chemotherapy-induced peripheral neuropathy (CIPN).
designThis study is a secondary analysis that leveraged data from a RCT of transcutaneous electrical stimulation for CIPN to test whether personalized outcomes could minimize potential floor effects and increase the assay sensitivity of pain clinical trials (ie, ability to detect a true treatment effect).
settingParticipants were recruited for a RCT from community oncology clinics in the United States.
participantsAdults with CIPN (N = 72) who reported on average ≥4 intensity (measured via a 7-day baseline diary) for at least 1 of the following pain qualities: hot/burning pain, sharp/shooting pain, and/or cramping.
methodsPersonalized outcomes were defined based on participants' unique presentation of pain qualities at baseline, measured via 0-10 numeric rating scales (NRS), or ranking of the distress caused by the pain qualities. Analysis of covariance models estimated the treatment effect as measured by personalized and non-personalized outcomes.
resultsThe adjusted mean difference between groups was higher using personalized outcomes (ie, 1.21-1.25 NRS points) compared to a non-personalized outcome (ie, 0.97 NRS points), although the standardized effect sizes were similar between outcomes (0.49-0.54).
conclusionsThese results suggest that personalized pain quality outcomes could minimize floor effects, while providing similar assay sensitivity to non-personalized pain quality outcomes. Personalized outcomes better reflect an individual's unique experience, inherently providing more clinically relevant estimates of treatment effects. Personalized outcomes may be advantageous, particularly for clinical trials in populations with high inter-individual variability in pain qualities.
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