Status:
COMPLETED
Treatment of Post-Traumatic Stress Disorder (PTSD) and Chronic Pain After Traumatic Orthopedic Injury
Lead Sponsor:
The University of Texas at Arlington
Collaborating Sponsors:
59th Medical Wing
Brooke Army Medical Center
Conditions:
Chronic Pain
Post-traumatic Stress Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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-mo...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00957164
Start Date
August 1 2009
End Date
September 1 2013
Last Update
January 31 2014
Active Locations (4)
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1
The University of Texas at Arlington
Arlington, Texas, United States, 76019
2
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
3
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236
4
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229