Treatment of Post-Traumatic Stress Disorder (PTSD) and Chronic Pain After Traumatic Orthopedic Injury
CompletedNot applicableNCT00957164
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Treatment of PTSD and Chronic Pain After Traumatic Orthopedic Injury: A Randomized Clinical Trial
- Conditions
- Chronic Pain
- Post-traumatic Stress Disorder
- Interventions
- Behavioral: Brief Prolonged Exposure Protocol
- Behavioral: Chronic Pain Management Treatment
- Behavioral: Self-Care
- Sponsor
- The University of Texas at Arlington
- Collaborators
- 59th Medical Wing; Brooke Army Medical Center; The University of Texas Health Science Center at San Antonio
- Start date
- 2009-08
- Primary completion
- 2012-09
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * age 18 years or older * hospital admission for any traumatic orthopedic injury defined as any musculo-skeletal injury requiring convalescence and/or surgery that is deployment related. * Fluency in English * Glasgow Coma Score (GCS) = 15 at time of hospital discharge * willingness and ability to meet study follow-up requirements * PTSD CheckList - Military (PCL-M) \> 30 * duration of any amount of pain \>12 weeks based on self-report and date of injury, and PTSD symptoms of \> to 4 weeks. * Pain Disability Questionnaire (PDQ) \> 30 * no current need for surgical intervention for pain * be stable on any psychotropic medications they may be taking. (Participants will be required to meet psychotropic medication stabilization criteria for the periods preceding and overlapping with the diagnostic assessment and treatment. This criterion is established in order to minimize the likelihood that significant outcome effects may be attributed to changes in psychotropic medications rather than to the treatment protocol.) * medically cleared for study participation by Orthopedic provider or collaborating study physician * Active Duty Military, Reserve, or Activated Reservist Exclusion Criteria: * head injury greater than mild TBI as assessed by an inability to consent to the study and complete the baseline psychological testing * current pregnancy will exclude participation in Functional Capacity Evaluation (FCE) assessment, but not study participation. Pregnancy will be assessed by self-report * current diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder as identified by clinical interview * primary diagnosis of burn injury, though burn patients will be eligible if burn is a secondary diagnosis and not the primary reason for pain * participant is currently taking a benzodiazepine medication for PTSD symptoms * unstable suicidal ideation * currently receiving prolonged exposure treatment for PTSD
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00957164