Study design: Discussion of issues and development of consensus. Objective: Present the background, purpose, development process, format and definitions of the International Spinal Cord Injury Pain (ISCIP) Classification. Methods: An international group of spinal cord injury (SCI) and pain experts deliberated over 2 days, and then via e-mail communication developed a consensus classification of pain after SCI. The classification was reviewed by members of several professional organizations and their feedback was incorporated. The classification then underwent validation by an international group of clinicians with minimal exposure to the classification, using case study vignettes. Based upon the results of this study, further revisions were made to the ISCIP Classification. Results: An overall structure and terminology has been developed and partially validated as a merger of and improvement on previously published SCI pain classifications, combined with basic definitions proposed by the International Association for the Study of Pain and pain characteristics described in published empiric studies of pain. The classification is designed to be comprehensive and to include pains that are directly related to the SCI pathology as well as pains that are common after SCI but are not necessarily mechanistically related to the SCI itself.
Conclusions:The format and definitions presented should help experienced and non-experienced clinicians as well as clinical researchers classify pain after SCI.
Results: The final ISCIPDS:B contains core questions about clinically relevant information concerning SCIrelated pain that can be collected by health-care professionals with expertise in SCI in various clinical settings. The questions concern pain severity, physical and emotional function and include a pain-intensity rating, a pain classification and questions related to the temporal pattern of pain for each specific pain problem. The impact of pain on physical, social and emotional function, and sleep is evaluated for each pain.
Current approaches to classification of chronic pain conditions suffer from the absence of a systematically implemented and evidence-based taxonomy. Moreover, existing diagnostic approaches typically fail to incorporate available knowledge regarding the biopsychosocial mechanisms contributing to pain conditions. To address these gaps, the Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks (ACTTION) public-private partnership with the US Food and Drug Administration and the American Pain Society (APS) have joined together to develop an evidence-based chronic pain classification system called the ACTTION-APS Pain Taxonomy (AAPT). This manuscript describes the outcome of an ACTTION-APS consensus meeting, at which experts agreed on a structure for this new taxonomy of chronic pain conditions. Several major issues around which discussion revolved are presented and summarized, and the structure of the taxonomy is presented. AAPT will include the following Dimensions: 1) Core Diagnostic Criteria, 2) Common Features, 3) Common Medical Comorbidities, 4) Neurobiological, Psychosocial and Functional Consequences, and 5) Putative Neurobiological and Psychosocial Mechanisms, Risk Factors & Protective Factors. In coming months, expert working groups will apply this taxonomy to clusters of chronic pain conditions, thereby developing a set of diagnostic criteria that have been consistently and systematically implemented across nearly all common chronic pain conditions. It is anticipated that the availability of this evidence-based and mechanistic approach to pain classification will be of substantial benefit to chronic pain research and treatment.
Perspective
The ACTTION-APS Pain Taxonomy is an evidence-based chronic pain classification system designed to classify chronic pain along the following Dimensions: 1) Core Diagnostic Criteria, 2) Common Features, 3) Common Medical Comorbidities, 4) Neurobiological, Psychosocial and Functional Consequences, and 5) Putative Neurobiological and Psychosocial Mechanisms, Risk Factors & Protective Factors.
The rationale for implantation of autologous human Schwann cells (SCs) in persons with subacute spinal cord injury (SCI) is based on evidence that transplanted SCs are neuroprotective, support local axonal plasticity, and are capable of myelinating axons. A Phase I clinical trial was conducted to evaluate the safety of autologous human SC transplantation into the injury epicenter of six subjects with subacute SCI. The trial was an open-label, unblinded, non-randomized, non-placebo controlled study with a dose escalation design and standard medical rehabilitation. Participants were paraplegics with neurologically complete, trauma-induced spinal lesions. Autologous SCs were cultured in vitro from a sural nerve harvested from each participant and injected into the epicenter of the spinal lesion. Outcome measures for safety were protocol compliance, feasibility, adverse events, stability of neurological level, absence of detectable mass lesion, and the emergence of clinically significant neuropathic pain or muscle spasticity no greater than expected for a natural course cohort. One year post-transplantation, there were no surgical, medical, or neurological complications to indicate that the timing or procedure for the cell transplantation was unsafe. There were no adverse events or serious adverse events related to the cell therapy. There was no evidence of additional spinal cord damage, mass lesion, or syrinx formation. We conclude that it is feasible to identify eligible candidates, appropriately obtain informed consent, perform a peripheral nerve harvest to obtain SCs within 5-30 days of injury, and perform an intra-spinal transplantation of highly purified autologous SCs within 4-7 weeks of injury.
Objectives: To revise the International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) based on new developments in the field and on suggestions from the spinal cord injury (SCI) and pain clinical and research community. Setting: International. Methods: The ISCIPBDS working group evaluated suggestions regarding the utility of the ISCIPBDS and made modifications in response to these and to significant developments in the field. The revised ISCIPBDS (version 2. shorten it in order to increase its clinical utility. In addition, there has been a significant update of the SCI pain taxonomy. 2,3 For these reasons, the ISCIPBDS working group decided to review and update the current version.Both the original and the revised ISCIPBDS (version 2.0) are intended to be collected by health-care professionals familiar with SCI, and to be used at the initial evaluation as well as at regular follow-up sessions. Data should be collected by interview and each question read to the patient or research participant as worded.The overall purpose of the ISCIPBDS (version 2.0) is unchanged and consistent with the purpose and vision of the International Spinal Cord Injury Data Sets. 4 The ISCIPBDS should be used together with the International SCI Core Data Set, 5 which includes information on date of birth and injury, gender, the cause of the SCI and neurological status including positive and negative sensory signs.
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