Background Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients’ short-term physical function. Objective Before unblinding and trial database lock, we describe a prespecified statistical analysis plan (SAP) for the CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) randomized controlled trial (RCT). Methods CYCLE is a 360-patient, international, multicenter, open-label, parallel-group RCT (1:1 ratio) with blinded primary outcome assessment at 3 days post-ICU discharge. The principal investigator and statisticians of CYCLE prepared this SAP with approval from the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes (including adverse events) and describes the planned primary, secondary, and subgroup analyses. The primary outcome of the CYCLE trial is the Physical Function Intensive Care Unit Test-scored (PFIT-s) at 3 days post-ICU discharge. The PFIT-s is a reliable and valid performance-based measure. We plan to use a frequentist statistical framework for all analyses. We will conduct a linear regression to evaluate the primary outcome, incorporating randomization as an independent variable and adjusting for age (≥65 years versus <65 years) and center. The regression results will be reported as mean differences in PFIT-s scores with corresponding 95% CIs and P values. We consider a 1-point difference in PFIT-s score to be clinically important. Additionally, we plan to conduct 3 subgroup analyses: age (≥65 years versus <65 years), frailty (Baseline Clinical Frailty Scale ≥5 versus <5), and sex (male versus female). Results CYCLE was funded in 2017, and enrollment was completed in May 2023. Data analyses are complete, and the first results were submitted for publication in 2024. Conclusions We developed and present an SAP for the CYCLE RCT and will adhere to it for all analyses. This study will add to the growing body of evidence evaluating the efficacy and safety of ICU-based rehabilitation interventions. Trial Registration ClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 and NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830 International Registered Report Identifier (IRRID) RR1-10.2196/54451

To be International

The 2016 International Spinal Cord Society Sir Ludwig Guttmann Lecture. The aim of this review is to identify different symptoms and signs of neuropathic pain and spasticity after spinal cord injury (SCI) and to present different methods of assessing them. The objective is to discuss how a careful characterization of different symptoms and signs, and a better translation of preclinical findings may improve our understanding of the complex and entangled mechanisms of neuropathic pain and spasticity. A MEDLINE search was performed using the following terms: ‘pain’, ‘neuropathic’, ‘spasticity’, ‘spasms’ and ‘spinal cord injury’. This review identified different domains of neuropathic pain and spasticity after SCI and methods to assess them in preclinical and clinical research. Different factors important for pain description include location, onset, pain descriptors and somatosensory function, while muscle tone, spasms, reflexes and clonus are important aspects of spasticity. Similarities and differences between neuropathic pain and spasticity are discussed. Understanding that neuropathic pain and spasticity are multidimensional consequences of SCI, and a careful examination and characterization of the symptoms and signs, are a prerequisite for understanding the relationship between neuropathic pain and spasticity and the intricate underlying mechanisms.

/pdf/neuropathic-pain-and-spasticity-intricate-consequences-of-4dmxsv8fuz.pdf

Neuropathic pain and spasticity: intricate consequences of spinal cord injury

https://rapm.bmj.com/content/rapm/early/2021/01/06/rapm-2020-101960.full.pdf

Prevalence of chronic pain after spinal cord injury: a systematic review and meta-analysis.

Virtual reality for spinal cord injury-associated neuropathic pain: Systematic review.

In addition to restoration of bladder, bowel, and motor functions, alleviating the accompanying debilitating pain is equally important for improving the quality of life of patients with spinal cord injury (SCI). Currently, however, the treatment of chronic pain after SCI remains a largely unmet need. Electrical spinal cord stimulation (SCS) has been used to manage a variety of chronic pain conditions that are refractory to pharmacotherapy. Yet, its efficacy, benefit profiles, and mechanisms of action in SCI pain remain elusive, due to limited research, methodological weaknesses in previous clinical studies, and a lack of mechanistic exploration of SCS for SCI pain control. We aim to review recent studies and outline the therapeutic potential of different SCS paradigms for traumatic SCI pain. We begin with an overview of its manifestations, classification, potential underlying etiology, and current challenges for its treatment. The clinical evidence for using SCS in SCI pain is then reviewed. Finally, future perspectives of pre-clinical research and clinical study of SCS for SCI pain treatment are discussed.

Spinal Cord Stimulation for Pain Treatment After Spinal Cord Injury

The objective of this study was to develop the International Spinal Cord Injury Pain Extended Data Set (ISCIPEDS) with the purpose of guiding the assessment and treatment of pain after spinal cord injury (SCI). International. The ISCIPEDS was reviewed by members of the International SCI Data Sets Committee, the International Spinal Cord Society Executive and Scientific Committees, American Spinal Injury Association and American Pain Society Boards, and the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain, individual reviewers and societies. The working group recommended four assessment domains for the ISCIPEDS: (i) Pain symptoms including variables related to pain type, temporal course, severity, unpleasantness, tolerability of pain and questionnaires assessing pain type and symptom severity; (ii) Sensory signs to detect and quantify sensory abnormalities commonly associated with neuropathic pain, including dynamic mechanical and thermal allodynia, and hyperalgesia; (iii) Treatments (ongoing and past 12 months); and (iv) Psychosocial factors and comorbid conditions. The ISCIPEDS was designed to be used together with the International SCI Pain Basic Data Set and provide a brief yet thorough assessment of domains related to chronic pain in individuals with SCI. The data set includes pain-relevant self-reported assessments, questionnaires and sensory examinations. The recommendations were based on (i) their relevance to individuals with SCI and chronic pain, (ii) the existence of published findings supporting the utility of the selected measures for use in individuals with SCI, and to the greatest extent possible (iii) their availability in the public domain free of charge.

/pdf/the-international-spinal-cord-injury-pain-extended-data-set-33u60py92n.pdf

The International Spinal Cord Injury Pain Extended Data Set (Version 1.0)

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The International Spinal Cord Injury Pain Extended Data Set (Version 1.0)