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: 8640964
• 负责人: FRANK J SYMONS
• 金额: $ 47.49万
• 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/8640964
• 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)：本申请涉及疼痛研究中的PA 10-006机制、模型、测量和管理(R01)。大多数脑性瘫痪(CP)儿童生活在痉挛和痉挛诱发的致残慢性疼痛中。痉挛的一线治疗之一是通过手术植入泵进行鞘内分娩。 巴氯芬(ITB)。这样做避免了口服巴氯芬的问题，但本身也会产生问题，包括一般的手术风险，但也会产生特定程序的问题，如脑脊液(CSF)泄漏和导管故障，导致严重的停药并发症。因此，这一过程并非没有风险，但总的来说，证据倾向于通过减少痉挛来治疗痉挛的疗效。然而，不太清楚的是，慢性疼痛是否也一直在减少。对于疼痛的结果，有混合和混乱的结果；混合的是因为在一些研究中疼痛据报道减少，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得很差，疼痛的测量很差，所以结果在科学上不确定，在临床上也是模棱两可的。这个具体的问题--经过ITB治疗后疼痛是否有所改善--是一个更广泛的一般问题的一部分--我们是否可以利用疼痛研究的科学进步来提高我们对疼痛和残疾的临床理解，这些儿童患有与神经发育障碍相关的严重智力、运动和沟通障碍。这项应用的总体目标是启动一系列研究，主要目标是提高我们对慢性疼痛变化的科学理解，以回应患有严重神经发育障碍的儿童的治疗。这项跨学科翻译建议的具体目的是通过前瞻性地研究ITB植入前后患有脑性瘫痪和痉挛的儿童样本，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)详细检查痉挛状态的变化和疼痛之间的关系，(B)评估即使痉挛程度降低也仍然存在的疼痛是否会与较差的功能结果相关，以及(C)经验性地测试与泵植入相关的治疗参数、与CP相关的临床特征或与疼痛、应激和炎症相关的生理变量是否相互作用来影响疼痛特异性治疗结果。到目前为止，还没有针对接受ITB泵植入治疗的CP儿童的慢性疼痛的全面研究。考虑到拟议项目的脆弱临床人群，我们认为当务之急是尝试在与现实世界疼痛和残疾问题相关的“长凳”上取得科学进展。最终，在改进患者选择标准方面，通过更全面地告知患者、他们的家人和医疗保健提供者关于疼痛和功能的所有预期结果，所获得的知识应该转化为临床决策助手。