Intrathecal Baclofen and Pain Outcomes in Cerebral Palsy

鞘内注射巴氯芬与脑瘫的疼痛结果

• 批准号: 8503247
• 负责人: FRANK J SYMONS
• 金额: $ 49.67万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8503247
• 关键词: Accounting; Activities of Daily Living; Address; Analgesics; Baclofen; Belief; Biological; Biological Markers; Caregivers; Catheters; Cerebral Palsy; Cerebrospinal Fluid; Characteristics; Child; Chronic; Chronic disabling pain; Clinical; Cognitive; Congenital musculoskeletal anomalies; Data; Decision Making; Distress; Dose; Equilibrium; Failure; Family; Family member; Frequencies; Goals; Health Personnel; Immune; Impairment; Implant; Individual Differences; Inflammation; Inflammatory; Knowledge; Life; Measurement; Measures; Modeling; Motor; Muscle Contraction; Muscle Spasticity; Muscular Dystrophies; Musculoskeletal; Neurodevelopmental Disability; Neurodevelopmental Disorder; Neurosecretory Systems; Nociception; Operative Surgical Procedures; Outcome; Pain; Pain Nature; Pain Research; Pain management; Patient Selection; Patients; Physiological; Physiology; Population; Procedures; Process; Proxy; Psychosocial Factor; Public Health; Pump; Quality of life; Reporting; Research; Rett Syndrome; Risk; Sampling; Schedule; Scientific Advances and Accomplishments; Selection Criteria; Seroma; Severities; Stress; Structure; Subgroup; Syndrome; System; Testing; Treatment outcome; Vulnerable Populations; Withdrawal; Work; Wound Infection; bench to bedside; chronic pain; clinical decision-making; clinically relevant; design; disability; experience; functional outcomes; improved; innovation; insight; novel; primary outcome; prospective; psychosocial; public health relevance; response; treatment effect

DESCRIPTION (provided by applicant): This application addresses PA 10-006 Mechanisms, Models, Measurement, and Management in Pain Research (R01). The majority of children with cerebral palsy (CP) live with spasticity and spasticity-induced disabling chronic pain. One of the front-line treatments for spasticity involves surgically implanting a pump to intrathecally deliver baclofen (ITB). Doing so avoids the problems with orally administered baclofen but creates problems of its own including general surgical risks but also procedure specific issues such as cerebral spinal fluid (CSF) leaks and catheter malfunction leading to serious withdrawal complications. Thus, the procedure is not without risk, but on balance the evidence is tilted toward efficacy for spasticity outcomes by reducing spasticity. It is less clear, however, whether the chronic pain is also and always reduced. There are mixed and muddled results specific to pain outcomes; mixed because in some studies pain is reported to decrease but in others there is no apparent change, muddled because the majority of the studies are poorly designed with pain poorly measured and so the results are scientifically uncertain and clinically ambiguous. This specific problem - whether or not pain improves following ITB treatment - is part of a much broader general issue - whether we can use scientific advances from pain research to improve our clinical understanding of pain and disability among children with significant intellectual, motor, and communicative impairments associated with neurodevelopmental disorders. The overall goal of this application is to initiate a line of research with the primary objective of improving our scientific understanding of changes in chronic pain in response to treatment among children with significant neurodevelopmental disabilities. The specific purpose of this interdisciplinary translational proposal is to clarify the clinical ambiguity in pain outcomes in relation to ITB treatment by prospectively studying a sample of children with CP and spasticity before and after ITB implant. By doing so, we will be able to (a) examine in detail the relation between changes in spasticity and pain, (b) evaluate whether pain that persists even in the presence of reduced spasticity will be associated with poorer functional outcomes, and (c) empirically test whether treatment parameters associated with the pump implant, clinical features associated with CP, or physiological variables associated with pain, stress, and inflammation interact to influence pain specific treatment outcomes. To date, there has been no comprehensive study specific to chronic pain among children with CP treated with ITB pump implants. Considering the vulnerable clinical population for the proposed project, we believe there is an urgent imperative to try to make scientific advances from the 'bench' relevant to real-world pain and disability problems. Ultimately, the knowledge gain should transfer into a clinical decision making aide with respect to improving patient selection criteria and by informing patients, their families, and healthcare providers more completely about the full range of expected outcomes with respect to pain and function.

描述（由申请人提供）：本申请涉及 PA 10-006 疼痛研究中的机制、模型、测量和管理 (R01)。大多数脑瘫（CP）儿童患有痉挛和痉挛引起的致残性慢性疼痛。痉挛的一线治疗方法之一是通过手术植入泵以进行鞘内输送 巴氯芬（ITB）。这样做可以避免口服巴氯芬的问题，但也会产生其自身的问题，包括一般手术风险，但也存在手术具体问题，如脑脊液 (CSF) 渗漏和导管故障，导致严重的停药并发症。因此，该手术并非没有风险，但总的来说，证据倾向于通过减少痉挛来改善痉挛结果。然而，尚不清楚慢性疼痛是否也总是减轻。对于疼痛的结果，有一些混合且混乱的结果；混合是因为在一些研究中据报告疼痛减轻了，但在其他研究中没有明显的变化，混乱是因为大多数研究设计不佳，疼痛测量不善，因此结果在科学上是不确定的，在临床上是模糊的。这个具体问题——ITB治疗后疼痛是否有所改善——是一个更广泛的普遍问题的一部分——我们是否可以利用疼痛研究的科学进展来提高我们对智力、运动和沟通能力显着的儿童的疼痛和残疾的临床理解与神经发育障碍相关的损伤。该应用程序的总体目标是启动一系列研究，其主要目标是提高我们对患有严重神经发育障碍的儿童因接受治疗而导致的慢性疼痛变化的科学理解。这项跨学科转化提案的具体目的是通过前瞻性研究 ITB 植入前后患有 CP 和痉挛的儿童样本，澄清与 ITB 治疗相关的疼痛结果的临床模糊性。通过这样做，我们将能够（a）详细检查痉挛和疼痛变化之间的关系，（b）评估即使在痉挛减轻的情况下持续的疼痛是否会与较差的功能结果相关，以及（c） ）凭经验测试与泵植入物相关的治疗参数、与 CP 相关的临床特征或与疼痛、压力和炎症相关的生理变量是否相互作用，从而影响疼痛特定的治疗结果。迄今为止，还没有专门针对接受 ITB 泵植入物治疗的 CP 儿童慢性疼痛的综合研究。考虑到拟议项目的弱势临床人群，我们认为迫切需要尝试在与现实世界的疼痛和残疾问题相关的“工作台”上取得科学进展。最终，所获得的知识应该转化为临床决策助手，以改善患者选择标准，并更全面地告知患者、患者家属和医疗保健提供者有关疼痛和功能的全部预期结果。