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.
Chronic pain and opioid use are significant problems among Veterans, especially those with chronic pain and psychiatric trauma. If successful, this study would provide huge impact by offering a non-medication alternative for pain management that decreases opioid use in Veterans with pain and psychological distress (i.e., depression, PTSD).