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的回应，“美国军人、退伍军人及其家属治疗疼痛和共病的非药物方法的临床试验和介入性研究”。长期自由行动（OEF）、伊拉克自由行动（OIF）和新黎明行动（OND）的服役人员慢性疼痛率稳步上升。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精神问题，如抑郁症和创伤后应激障碍（PTSD），这导致治疗反应下降，慢性阿片类药物使用的风险增加。圣安东尼奥退伍军人综合服务网络（visn17）最近的一项研究发现，氢可酮是VISN中最常用的处方药。此外，40%服用阿片类药物的退伍军人使用时间超过3个月。对于患有共病性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。在多病退伍军人中，慢性阿片类药物的使用与康复效果差、滥用其他物质和死亡（特别是在多病退伍军人中，服用苯二氮卓类药物治疗共病PTSD）有关。美国国立卫生研究院公告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使用问题。为了在多病退伍军人人群中有效，慢性疼痛项目需要(a)与军人人群相关，(b)基于来自军事疼痛和多病创伤样本的证据，以及(c)旨在克服军事疼痛患者慢性阿片类药物使用的已知障碍（耻辱，缺乏替代疼痛管理资源）。我们的研究团队旨在根据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），着名的军事创伤调查员（Peterson博士，young - mcoughan博士）和丰富的军事阿片类药物滥用研究人员（Potter博士，Dawes博士）之间的合作来解决这些标准。该团队在广泛的前期研究基础上制定了一项手动疼痛管理计划，该计划将通过以下两个主要目标解决OEF/OIF/OND退伍军人慢性腰痛的多病疼痛和慢性阿片类药物使用的重大问题：1)评估FORT-A方案对（N=130）多病OEF/OIF/OND PRC退伍军人慢性腰痛（LBP）疼痛管理结果的改善效果，采用1:1随机临床试验比较FORT-A与标准PRC治疗。2)评估FORT-A在降低OEF/OIF/OND多病LBP退伍军人慢性阿片类药物治疗率方面的疗效，与标准PRC治疗相比。

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.