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

建立基于功能恢复的 CAM 疼痛管理项目的功效

• 批准号: 9096087
• 负责人: DONALD DOUGLAS MCGEARY
• 金额: $ 55.19万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9096087
• 关键词: Accounting; Activities of Daily Living; Acute; Address; Aftercare; Alternative Medicine; Area; Benzodiazepines; Biofeedback; Caring; Cessation of life; Chronic; Chronic low back pain; Clinic; Clinical; Clinical Trials; Cognitive Therapy; Collaborations; Data; Department of Defense; Diagnosis; Event; Exercise; Family; Freedom; Funding Opportunities; Future; Health; Healthcare Systems; Hydrocodone; Imagery; Injection of therapeutic agent; Intervention; Interview; Link; Low Back Pain; Mediator of activation protein; Mental Depression; Military Personnel; Monitor; Musculoskeletal Pain; Opioid; Orthopedics; Outcome; Outcome Measure; Pain; Pain management; Patients; Pharmaceutical Preparations; Physical therapy; Play; Population; Post-Traumatic Stress Disorders; Process; Randomized Clinical Trials; Randomized Controlled Trials; Rehabilitation Outcome; Rehabilitation therapy; Relaxation; Reporting; Research; Research Personnel; Resources; Risk; Role; Sampling; Services; South Texas; System; Testing; Time; TimeLine; Trauma; Traumatic Brain Injury; United States National Institutes of Health; Veterans; Work; base; chronic pain; coping; design; disability; emotional distress; experience; follow-up; functional restoration; health administration; high risk; improved; indexing; medical specialties; meetings; member; mindfulness meditation; operation; opioid abuse; opioid use; pain symptom; pill; prescription opioid; primary outcome; programs; psychiatric symptom; psychologic; psychological distress; randomized trial; response; secondary outcome; social stigma; treatment response; trial comparing

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.

描述（由申请人提供）：此申请是对RFA-AT-14-003的响应，“非药理方法的临床试验和介入研究，用于管理美国军事人员，退伍军人及其家人的疼痛和合并状况。”在持久自由（OEF），伊拉克自由（OIF）和New Dawn（OND）的运营的服务成员中，慢性疼痛的发生率稳步上升。 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诸如抑郁症和创伤后应激障碍（PTSD）等精神病问题，这有助于减少治疗反应并增加慢性阿片类药物使用的风险。圣安东尼奥退伍军人综合服务网络（VISN 17）的最新研究发现，氢可酮是VISN中最常见的药物。此外，服用阿片类药物的退伍军人中有40％使用它超过3个月。对于患有合并疼痛和精神病症状的退伍军人（称为“多虫”退伍军人），长期使用阿片类药物（每月使用阿片类药物为30天，持续30天，持续3个月或更长时间）可能是特别有害的。多虫退伍军人之间的慢性阿片类药物使用与康复结果不良，滥用其他物质和死亡有关（尤其是在多种多样的退伍军人中，开处方了苯并二氮卓类药物以合并症PTSD）。 NIH公告描述了对可以有意义地解决慢性疼痛管理和阿片类药物使用的非药物疼痛管理计划的迫切需求。要在多种多样的退伍军人人群中有效，需要（a）与军事人群有关的慢性疼痛计划，（b）基于军事疼痛和多虫创伤样本的证据，并且（c）旨在克服已知的障碍，以在军事疼痛患者中（污名患者，缺乏替代疼痛管理资源）中的慢性阿片类药物使用障碍。 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）使用将FORT-A与标准PRC护理进行比较的1：1随机临床试验。 2）评估Fort-A在OEF/OIF/OIF/OND Polymorbid LBP退伍军人样本中，与标准PRC护理相比，FORT-A的疗效降低了慢性阿片类药物治疗率。