Articles: pain-measurement.
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Randomized Controlled Trial Multicenter Study Comparative Study
Multicenter, Randomized, Double-Blind Study Protocol Using Human Spinal Cord Recording Comparing Safety, Efficacy, and Neurophysiological Responses Between Patients Being Treated With Evoked Compound Action Potential-Controlled Closed-Loop Spinal Cord Stimulation or Open-Loop Spinal Cord Stimulation (the Evoke Study).
The spinal cord (SC) response to stimulation has yet to be studied in a pivotal clinical study. We report the study design of an ongoing multicenter, randomized, double-blind, controlled, parallel-arm study of an evoked compound action potential (ECAP) controlled closed-loop spinal cord stimulation (SCS) system, which aims to gain U.S. Food and Drug Administration approval. ⋯ All approved SCS therapies, regardless of the presence or absence of stimulation induced paresthesias, produce fixed-output stimuli; that is, the energy delivered from the electrode array has a defined output irrespective of the neural response of SC fibers. An SCS system has been developed that directly measures the neurophysiologic activation of the SC to stimulation (i.e., ECAP amplitude) and uses this information in a feedback mechanism to produce closed-loop SCS to maintain optimal and stable activation of the SC. This study represents the first randomized, double-blind, pivotal study in the field of neuromodulation to measure SC activation in ECAP-controlled closed-loop versus open-loop stimulation and is expected to yield important information regarding differences in safety, efficacy, and neurophysiological properties. The potential clinical utility of these objective measurements of SC activation and other neurophysiological properties promises to improve outcomes of SCS for chronic pain patients.
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Multicenter Study Observational Study
Validation of the Rotterdam Elderly Pain Observation Scale in the Hospital Setting.
The Rotterdam Elderly Pain Observation Scale (REPOS) has been proven useful to assess pain in noncommunicative and cognitively impaired nursing home residents. We evaluated whether the REPOS is also reliable and valid for pain assessment in the hospital setting. ⋯ The REPOS is reliable and valid for the assessment of postoperative and chronic pain in hospital patients who cannot self-report pain.
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Many neonatal observational pain assessment tools are available. Their application in clinical settings, however, has been limited. A further difficulty for decision makers may be to choose among the variety of available tools the appropriate one(s) for their patients. Aims of the present study were (1) to compare two commonly cited neonatal pain assessment tools, the Neonatal Facial Coding System-Revised (NFCS-R) and the Children and Infant's Postoperative Pain Scale (CHIPPS), with regard to their psychometric qualities and (2) to explore intuitive clinicians' ratings by relating them to the tools' items. ⋯ Psychometric comparisons of neonatal assessment tools provide useful information that can help health care professionals to choose among tools and researchers to improve them. Both tools compared here performed psychometrically equally well. Their clinical utility, however, can be improved, for example by providing a manual (CHIPPS) and training opportunities.
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In experiments on pain, participants are frequently exposed to nonpainful and painful stimuli; however, the conventional pain-rating scales lack a nonpainful range and a clear point of transition from nonpainful to painful events. The Sensation and Pain Rating Scale (SPARS) assesses the full stimulus intensity range, extending from no sensation (rating: -50) to worst pain imaginable (rating: +50), and it explicitly identifies pain threshold (rating: 0). Here, we tested the SPARS in 2 experiments by using laser heat stimuli to establish its stimulus-response characteristics (Experiment 1, N = 19, 13 stimulus intensities applied 26 times each across a 1-4 J range), and compared it to 0 to 100 scales that assess nonpainful (0: no sensation, 100: pain) and painful (0: no pain, 100: worst pain imaginable) events (Experiment 2, N = 7, 9 stimulus intensities applied 36 times each across a 1.5-4.5 J range). ⋯ As such, it is well suited to experimental studies that must quantify a wider range of perceptual intensity or distinguish between painful and nonpainful events. PERSPECTIVE: This article presents the stimulus-response characteristics of a new scale designed to allow participants to rate a range of nonpainful and painful stimuli. The scale could be useful for research that involves exposing participants to a range of stimulation intensities or requires a clear distinction between nonpainful and painful events.
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The purpose of this study was to conduct classical psychometric evaluation and Rasch analysis on the Neuropathic Qualities subscale of the Short-Form McGill Pain Questionnaire-2 utilizing scores from persons with complex regional pain syndrome to consider reliability and person separation, validity (including unidimensionality), and responsiveness in this population. ⋯ This study provided preliminary support for the validity and responsiveness of the Neuropathic Qualities subscale in persons with complex regional pain syndrome. Rasch analysis further endorses use of the Neuropathic Qualities subscale as a "stand-alone" measure for neuropathic features, but with substantial background data transformations. Replication with larger samples is recommended to increase confidence in these findings.