Establishing efficacy of a functional-restoration-based CAM pain management progr

描述(由申请人提供)：本申请是对RFA-AT-14-003号文件的回应，该文件名为“美国军人、退伍军人及其家属控制疼痛和共病的非药物方法的临床试验和干预性研究”。在部署在持久自由行动(OEF)、伊拉克自由行动(OIF)和新黎明行动(OND)中的服役人员中，慢性疼痛的比率稳步上升。2009年的一项研究发现，大多数患有慢性疼痛的退伍军人还报告了抑郁和创伤后应激障碍(PTSD)等精神问题，这导致治疗反应降低，慢性阿片类药物使用风险增加。圣安东尼奥退伍军人综合服务网络(VISN 17)最近的一项研究发现，氢可酮是VISN中最常用的单一处方药。此外，40%服用阿片类药物的退伍军人使用时间超过3个月。对于同时患有疼痛和精神症状的退伍军人(称为“多病”退伍军人)，长期使用阿片类药物(每月30天中有20天使用阿片类药物，持续3个月或更长时间)可能特别危险。多病退伍军人中长期使用阿片类药物与康复结果差、滥用其他物质和死亡有关(特别是在多病退伍军人中，为并发创伤后应激障碍而开苯二氮卓类药物的人尤其如此)。NIH的声明描述了对非药物疼痛管理计划的迫切需求，这些计划可以有意义地解决慢性疼痛管理和阿片类药物的使用问题。为了在患有多种疾病的退伍军人中有效，慢性疼痛方案需要(A)与军事人口相关，(B)基于来自军事疼痛和多病态创伤样本的证据，以及(C)旨在克服军事疼痛患者长期使用阿片类药物的已知障碍(耻辱，缺乏替代疼痛管理资源)。我们的研究团队旨在解决这些标准，合作的基础是经验丰富的军事疼痛管理专家(Don McGeary博士、Cindy McGeary博士、Simmonds博士、Pugh博士)、经验丰富的退伍军人临床研究人员(Jaramillo博士、Eapen博士)、知名军事创伤调查人员(Peterson博士、Young-McCoughan博士)以及多产的军事阿片滥用研究人员(Potter博士、Dawes博士)。该团队在广泛先前研究的基础上开发了一种手工化的疼痛管理计划，该计划将通过以下两个主要目标解决患有慢性下腰痛的OEF/OIF/OND退伍军人中的多病态疼痛和慢性阿片类药物使用的重大问题：1)使用1：1随机临床试验，比较Fort-A和标准PRC护理，评估Fort-A计划改善(N=130)多病态OEF/OIF/OND PRC退伍军人慢性下腰痛(LBP)的疼痛管理结果的有效性。2)评估Fort-A与标准PRC护理相比，在OEF/OIF/OND多病态LBP退伍军人样本中降低慢性阿片类药物治疗率的有效性。

DESCRIPTION (provided by applicant): This application is in response to RFA-AT-14-003, "Clinical trials and interventional studies of non- pharmacological approaches to managing pain and co-morbid conditions in U.S. Military personnel, Veterans, and their families." Rates of chronic pain have steadily increased among service members deployed for Operations Enduring Freedom (OEF), Iraqi Freedom (OIF), and New Dawn (OND). A 2009 study found that the majority of Veterans with chronic pain also report psychiatric concerns like depression and posttraumatic stress disorder (PTSD), which contribute to decreased treatment response and increased risk of chronic opioid use. A recent study in the San Antonio Veterans Integrated Service Network (VISN 17) found that hydrocodone is the single most commonly prescribed medication in the VISN. Furthermore, 40% of Veterans taking opioid medication use it for more than 3 months. For Veterans with comorbid pain and psychiatric symptoms (referred to as "polymorbid" Veterans), long-term opioid use (using opioid medication for 20 out of 30 days each month for 3 or more months) can be particularly hazardous. Chronic opioid use among polymorbid Veterans has been linked to poor rehabilitation outcomes, abuse of other substances, and death (especially among polymorbid Veterans prescribed benzodiazepine medications for comorbid PTSD). The NIH Announcement describes the urgent need for non-medication pain management programs that can meaningfully address chronic pain management and opioid use. To be effective in a polymorbid Veteran population, a chronic pain program needs to be (a) relevant to military populations, (b) based on evidence derived from military pain and polymorbid trauma samples, and (c) designed to overcome known obstacles to chronic opioid use among military pain patients (stigma, lack of alternative pain management resources). Our research team was designed to address these criteria based on collaboration between experience military pain management experts (Dr. Don McGeary, Dr. Cindy McGeary, Dr. Simmonds, Dr. Pugh), experience polymorbid VA clinical researchers (Dr. Jaramillo, Dr. Eapen), renowned military trauma investigators (Dr. Peterson, Dr. Young-McCoughan), and prolific military opioid abuse researchers (Dr. Potter, Dr. Dawes). This team has developed a manualized pain management program based on extensive prior research that will address the significant problems of polymorbid pain and chronic opioid use among OEF/OIF/OND Veterans with chronic low back pain through the following two primary aims: 1) Assess the efficacy of the FORT-A Program for improved pain management outcomes in (N=130) polymorbid OEF/OIF/OND PRC Veterans with chronic low back pain (LBP) using a 1:1 randomized clinical trial comparing FORT-A to standard PRC care. 2) Assess the efficacy of FORT-A for decreasing the rate of chronic opioid therapy compared to standard PRC care in a sample of OEF/OIF/OND polymorbid LBP Veterans.