Prediction and Prevention of Persistent Post-Mastectomy Pain

乳房切除术后持续疼痛的预测和预防

• 批准号: 9402610
• 负责人: KRISTIN SCHREIBER
• 金额: $ 16.87万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-15 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9402610
• 关键词: Achievement; Affect; Animal Model; Anxiety; Biometry; Cancer Center; Characteristics; Chronic; Clinical; Clinical Trials; Data; Detection; Development; Doctor of Philosophy; Effectiveness of Interventions; Enrollment; Future; Health Personnel; High Risk Woman; Individual; Individual Differences; Intervention Trial; Investigation; Ketamine; Mastectomy; Measures; Medical; Mental Depression; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Modeling; Nature; Nociception; Noise; Operative Surgical Procedures; Pain; Pain Threshold; Patient risk; Patients; Perioperative; Persons; Pharmaceutical Preparations; Pharmacy (field); Physiology; Placebos; Play; Postoperative Pain; Pre-Clinical Model; Preemptive Analgesia; Prevention; Preventive; Preventive Intervention; Preventive treatment; Prospective Studies; Psychology; Psychophysics; Psychosocial Factor; Radiation therapy; Research Personnel; Retrospective Studies; Risk; Risk Factors; Role; Screening procedure; Sensory; Signal Transduction; Sleep disturbances; Societies; Stimulus; Syndrome; Testing; Therapeutic Trials; Time; Training; Translations; Treatment Factor; Woman; Work; aging population; base; career; career development; chemotherapy; chronic pain; chronic painful condition; clinical infrastructure; clinical translation; cohort; cost; design; high risk; improved; indexing; malignant breast neoplasm; negative affect; novel; novel therapeutics; pain patient; pain processing; pain sensitivity; pre-clinical; predictive modeling; pressure; prevent; prospective; psychologic; psychosocial; public health relevance; skills; statistics; success; surgical pain; therapeutic effectiveness; tool

DESCRIPTION (provided by applicant): Chronic pain is devastating both to individuals and society. In an aging population, surgery is an increasing cause of chronic pain, with rates of persistent post-operative pain ranging from 10-65%. In particular, Persistent Post-Mastectomy Pain (PPMP) occurs in roughly one third of women who have had mastectomy. The occurrence of PPMP does not seem to be strongly determined by the type of surgery, chemotherapy, and radiation treatment, suggesting that individual person-specific factors may play a more important role. In fact, recent studies by the candidate indicate that individual differences in pain sensitiity (psychophysics) are more closely associated with PPMP than surgical/medical variables. Specifically, sensory testing revealed that women who developed PPMP had lower pressure pain thresholds and greater temporal summation of pain stimuli than women who did not develop this chronic pain condition. Moreover, psychosocial factors such as anxiety, depression, catastrophizing, and somatization were more prominent in women with PPMP. These preliminary, retrospective studies suggest that individual psychophysical and psychosocial characteristics could be important risk factors for PPMP. Accordingly, the first Aim of this study is to comprehensively and prospectively study women having mastectomy surgery, to determine the relationship between pre-operative psychophysical and psychosocial factors and the development of PPMP. The second Aim is to develop a prediction model for PPMP using the data collected in Aim 1, thus allowing a preoperative calculation of a "PPMP risk score" for any patient facing mastectomy. This will then be validated in a separate group of patients (study 2). Study will be this risk score will be used to enrich an interventional trial with a greater proporton of women at high risk of PPMP, with Aim 3 to investigate whether this enrichment allows more efficient and sensitive determination of a preventative drug's effect than in an unscreened group. These studies will lay the groundwork to efficiently test novel pharmaceutics only in the high risk patients who need them. The candidate in this application, Dr. Kristin Schreiber is a PhD-trained Neuroscientist and Anesthesiologist at a leading academic, high-volume breast cancer center. The proposed studies would inform healthcare providers about the underlying mechanisms contributing to chronic pain after surgery, thus allowing more targeted, preventive treatment in patients who are high risk for persisting post-operative pain. Her career development mentors are experts in surgical, medical, psychological, and preoperative assessment, preclinical modeling, and biostatistics. The candidate's strong scientific background, taken together with the proposed formal training in advanced statistics and diverse mentorship, in a center that has a strong tradition and infrastructure for clinical trials, will enure the successful achievement of her scientific and career objectives to prevent PPMP and lay the groundwork for prevention of other persistent post-surgical pain syndromes.

描述（由申请人提供）：慢性疼痛对个人和社会都是毁灭性的。在老龄化人口中，手术是慢性疼痛的一个日益增加的原因，术后持续疼痛的发生率为10- 65%。特别是，乳房切除术后持续性疼痛（PPMP）发生在大约三分之一的乳房切除术女性中。PPMP的发生似乎并不是由手术、化疗和放疗的类型决定的，这表明个体的特定因素可能起着更重要的作用。事实上，候选人最近的研究表明，疼痛敏感性（心理物理学）的个体差异与PPMP的关系比手术/医疗变量更密切。具体来说，感觉测试显示，发展PPMP的女性比没有发展这种慢性疼痛状况的女性具有更低的压力疼痛阈值和更大的疼痛刺激时间总和。此外，焦虑、抑郁、灾难化和躯体化等心理社会因素在PPMP女性中更为突出。这些初步的回顾性研究表明，个人的心理生理和心理社会特征可能是PPMP的重要危险因素。因此，本研究的第一个目的是全面和前瞻性地研究妇女乳房切除术，以确定术前的心理和社会心理因素和PPMP的发展之间的关系。第二个目标是使用目标1中收集的数据开发PPMP的预测模型，从而允许对任何面临乳房切除术的患者术前计算“PPMP风险评分”。然后将在另一组患者中进行验证（研究2）。研究将使用该风险评分来丰富具有更大比例的PPMP高风险女性的干预性试验，目的3是调查这种富集是否允许比未筛选组更有效和灵敏地确定预防药物的效果。这些研究将为仅在需要的高风险患者中有效测试新型药物奠定基础。Kristin Schreiber博士是一位经过博士培训的神经科学家和麻醉师，在一家领先的学术，高容量乳腺癌中心工作。拟议的研究将告知医疗保健提供者有关手术后慢性疼痛的潜在机制，从而允许对术后持续疼痛的高风险患者进行更有针对性的预防性治疗。她的职业发展导师是外科、医学、心理学和术前评估、临床前建模和生物统计学方面的专家。候选人强大的科学背景，以及在一个具有强大传统和临床试验基础设施的中心进行的高级统计学和多样化指导的正式培训，将确保成功实现她的科学和职业目标，以预防PPMP，并为预防其他持续性术后疼痛综合征奠定基础。

项目成果

Conditioned open-label placebo for opioid reduction after spine surgery: a randomized controlled trial.

• DOI: 10.1097/j.pain.0000000000002185
• 发表时间: 2021-06-01
• 期刊: Pain
• 影响因子: 7.4
• 作者: Flowers KM;Patton ME;Hruschak VJ;Fields KG;Schwartz E;Zeballos J;Kang JD;Edwards RR;Kaptchuk TJ;Schreiber KL
• 通讯作者: Schreiber KL