Treatment of Post-Traumatic Stress Disorder (PTSD) and Chronic Pain After Traumatic Orthopedic Injury

Chronic Pain Clinical Trial

Official title: Treatment of PTSD and Chronic Pain After Traumatic Orthopedic Injury: A Randomized Clinical Trial

Status Completed

Clinical Trial Summary

The purpose of this study is to examine the efficacy of multiple treatment options in addressing the co-morbidity between pain and PTSD symptoms. Recent research has suggested that pain and PTSD co-morbidity presents unique problems for pain and PTSD treatment, and new approaches are desperately needed to address this issue. To this end, the investigators hope to identify the efficacy of a combined pain and PTSD psychosocial treatment protocol compared to that of stand-alone psychosocial treatments for pain and PTSD. The primary measure for treatment efficacy will be treatment-related changes in measures of psychosocial and functional outcomes associated with chronic pain and PTSD conditions. The investigators will additionally measure socioeconomic outcomes including return to pre-trauma job (or a job of similar capacity), maintenance of active duty work at pre-trauma capacity for 6 and/or 12 months after return, and number of healthcare appointments made between follow-ups for pain or PTSD treatment.

Clinical Trial Description

This study will use a four-group randomized experimental design similar to that used in a study currently being conducted by John Otis with VA patients with chronic pain/chronic PTSD. The four groups will include Pain Treatment (PAIN) only, PTSD Treatment (PTSD) only, Pain and PTSD Treatments (PAIN+PTSD), and treatment as usual (TAU). The investigators hypothesize that treating individuals with chronic pain and PTSD (e.g., more than 6 months in duration) symptoms through a proven psychosocial model will help to improve psychological, socioeconomic and physical symptoms of these chronic clinical syndromes that have been shown to be unfortunately recalcitrant to treatment and enormously costly both to society healthcare and, more importantly, to the person suffering from enduring pain and traumatic stress. We further hope to demonstrate the efficacy of these early treatments in facilitating the return to active duty of military personnel suffering from pain and traumatic stress. Finally, we hope to positively impact other psychosocial and socioeconomic outcomes such as work retention (as measured by self-report work status and retention of work at 6- and 12-month follow-up), additional health-care utilization (as measured by self-report of number of PTSD or pain-related healthcare visits), depression symptoms (as measured by the Beck Depression Inventory), health-related quality of life (as measured by the SF-36), and perceived disability (as measured by the Million Visual Analog Scale). Evaluations of these four groups will be conducted at pre-treatment, immediately at the post-treatment, and at 6- and 12-month follow-up periods in order to determine differential outcomes on variables such as PTSD and pain symptom presence/severity, self-reported pain and disability, functional gains, satisfaction with treatment, return to active duty, retention of pre-trauma work capacity at 6- and 12-month follow-up, and additional health-care utilization as measured by number of healthcare appointments attended for pain or PTSD symptom management. The initial post-treatment evaluation will occur at the end of the ten-week treatment interval for each individual's randomization block. For those in the treatment as usual (TAU) group, post-treatment assessment will occur ten weeks after pre-treatment assessment is completed. Changes in functional activity status, psychosocial functioning, and satisfaction with treatment will also be systematically evaluated before, immediately after, and during the post-treatment periods. It should be noted that many of the PAIN-only, and TAU subjects may receive some type of standard care for PTSD symptoms if they access those services on their own. The same could be true for the PTSD-only and TAU subjects. They may also receive some type of standard care for pain symptoms that they access on their own. The investigators will monitor any such services received in order to attempt to control for possible spurious effects of outside treatment in later analyses. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT00957164
• Study type: Interventional
• Source: The University of Texas at Arlington
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Completion date: September 2013