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

Widerström-Noga, Eva; Biering‐Sørensen, Fin; Bryce, Thomas N.; Cardenas, Diana D.; Finnerup, Nanna Brix; Jensen, Mark P.; Richards, J. S.; Richardson, Elizabeth; Siddall, Philip J.

doi:10.1038/sc.2016.51

Cited by 45 publications

(30 citation statements)

References 59 publications

(42 reference statements)

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“…38,39 Some of the factors relevant for characterizing neuropathic pain in clinical research are listed in Table 1 and are also recommended in the International SCI Pain Extended Data Set. 40 Several SCI models are used in preclinical research, including hemisection, contusion, ischemic and excitotoxic models, but pain assessment remains a challenge. One of the main reasons is the difficulty in assessing the correlate of spontaneous pain, which is the most frequent and troublesome pain symptom in humans.…”

Section: Multidimensional Assessment Of Painmentioning

confidence: 99%

Neuropathic pain and spasticity: intricate consequences of spinal cord injury

Finnerup

2017

Spinal Cord

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Section: Multidimensional Assessment Of Painmentioning

confidence: 99%

Neuropathic pain and spasticity: intricate consequences of spinal cord injury

Finnerup

2017

Spinal Cord

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“…SAEs will be monitored for the entire duration of the study. Patient-reported pain severity levels will be assessed daily during admission using the Neuropathic Pain Scale28 as well as the International Spinal Cord Injury Pain Basic Data Set version 2.0 29. Finally, neurological evaluation will be carried out at specific time points up to 1 year following tSCI to assess for changes in neurological status.…”

Section: Methods and Analysismentioning

confidence: 99%

SCING—Spinal Cord Injury Neuroprotection with Glyburide: a pilot, open-label, multicentre, prospective evaluation of oral glyburide in patients with acute traumatic spinal cord injury in the USA

et al. 2019

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IntroductionAcute traumatic spinal cord injury (tSCI) is a devastating neurological disorder with no pharmacological neuroprotective strategy proven effective to date. Progressive haemorrhagic necrosis (PHN) represents an increasingly well-characterised mechanism of secondary injury after tSCI that negatively impacts neurological outcomes following acute tSCI. Preclinical studies evaluating the use of the Food and Drug Administration-approved sulfonylurea receptor 1-transient receptor potential melastatin 4 channel blocker glyburide in rodent models have shown reduced secondary microhaemorrhage formation and the absence of capillary fragmentation, the pathological hallmark of PHN.Methods and analysisIn this initial phase multicentre open-label pilot study, we propose to enrol 10 patients with acute cervical tSCI to primarily assess the feasibility, and safety of receiving oral glyburide within 8 hours of injury. Secondary objectives include pharmacokinetics and preliminary evaluations on neurological recovery as well as blood and MRI-based injury biomarkers. Analysis will be performed using the descriptive and non-parametric statistics.Ethics and disseminationGlyburide has been shown as an effective neuroprotective agent in preclinical tSCI models and in the treatment of ischaemic stroke with the additional risk of a hypoglycaemic response. Given the ongoing secondary injury and the traumatic hyperglycaemic stress response seen in patients with tSCI, glyburide; thus, offers an appealing neuroprotective strategy to supplement standard of care treatment. The study protocol was approved by the Ohio State University Biomedical Institutional Review Board. The protocol was amended in February 2017 with changes related to study feasibility and patient recruitment. Specifically, the route of administration was changed to the oral form to allow for streamlined and rapid drug administration, and the injury-to-drug time window was extended to 8 hours in an effort to further enhance enrolment. Participants or legally authorised representatives are informed about the trial and its anticipated risks orally and in written form using an approved informed consent form prior to inclusion. The findings of this study will be disseminated to the participants and to academic peers through scientific conferences and peer-reviewed journal publications.Trial registration numbers NCT02524379 and 2014H0335.

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“…Rating of the PDQ is subdivided in three different diagnostic categories with respect to the probability of a NeuP component: (1) a NeuP component is unlikely (score ≤12; probability <15%), (2) result is ambiguous, however a neuropathic pain component can be present (score 13–18) and (3) a NeuP component is likely (score ≥19; probability >90%). The PDQ has also been applied in the context of other underlying causes of NeuP including SCI and by now is recommended as appropriate NeuP assessment in the field of SCI research (Hallstrom and Norrbrink, ; Widerstrom‐Noga et al., ). The PDQ was chosen for the following reasons: (1) the PDQ was primarily developed and validated in German and is – in contrast to the DN4 – open access available in Germany, (2) the PDQ has already been validated in SCI‐related NeuP, (3) the PDQ – alike the SCIPI – does not require a physical/clinical examination, and (4) the PDQ tests essentially the same underlying construct – NeuP.…”

Section: Methodsmentioning

confidence: 99%

“…Despite its validation in lower back pain, the PDQ was reported to show decent psychometric properties in SCI-related NeuP (Hallstrom and Norrbrink, 2011;Mathieson et al, 2015). Accordingly, the PDQ was endorsed by the International Spinal Cord Society as assessment tool for SCI-related NeuP (Widerstrom-Noga et al, 2016). These facts justify a reanalysis of validity of PDQ according to the current definition of neuropathic pain.…”

Section: Introductionmentioning

confidence: 99%