Pain, Psychiatric Disorders, and Disability Among Veterans With and Without Polytrauma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00645970
First received: March 24, 2008
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

We believe information to be obtained from this proposed study will prove critical for planning future VA healthcare strategies and developing effective and efficient treatments targeting pain and emotional adjustment difficulties among individuals with polytrauma and returning Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) personnel. More specifically, this study will be the first to provide systematic data regarding pain and emotional problem prevalence, course, associated impairments, risk factors, and barriers to care and community reintegration among returning OEF and OIF service members with and without polytrauma.


Condition
Chronic Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain, Psychiatric Disorders, and Disability Among Veterans With and Without Polytrauma

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Numeric Rating Scales of pain over past week (11 point Likert Scale) [ Time Frame: Baseline, 6 months, 1 year ] [ Designated as safety issue: No ]

Enrollment: 354
Study Start Date: July 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Two non-stratified samples of participants will be recruited at each study site. A polytrauma injury group (PTR) will be comprised of between 150 and 200 inpatients or former inpatients returning for additional rehabilitation care to the Minneapolis and Tampa PRCs (ns = 75-100 at each site). PTR subjects will be subdivided into those with combat polytrauma (60% based on current data) and those with non-combat polytrauma (40%) for selected subsequent analyses. A comparison group of between 300 and 400 non-polytrauma OEF/OIF service members (NPTR) will be sampled randomly from the pool of all veterans on the Minneapolis and Tampa OEF/OIF patient registries (ns = 150-200 at each site). This latter group will be dichotomized into those with pain (NPTR-P; approximately 42 - 50% based on our previous research) and those without (NPTR-NP) for later analyses.

Criteria

Inclusion Criteria:

for Polytrauma Participants

  • Was deployed to Iraq or Afghanistan between October 2001 and the present
  • Meets the VA definition of polytrauma injury
  • Received medical clearance from attending physician to participate in study
  • Able to provide valid self-report of pain level using 0-10 numeric rating scale
  • Fluent in verbal and written English
  • Rancho Los Amigos level 6
  • Competent to provide full informed consent

for Non-Polytrauma Participants

  • Was deployed to Iraq or Afghanistan between October 2001 and the present
  • Fluent in verbal and written English
  • Able to provide valid self-report of pain level using 0-10 numeric rating scale
  • Competent to provide full informed consent

Exclusion Criteria:

see above.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645970

Locations
United States, Florida
James A. Haley Veterans' Hospital
Tampa, Florida, United States, 33637-1022
Sponsors and Collaborators
Investigators
Principal Investigator: Michael E Clark, PhD MA James A. Haley Veterans Hospital
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00645970     History of Changes
Other Study ID Numbers: SDR 07-047
Study First Received: March 24, 2008
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
chronic pain
combat injuries
pain assessment
multiple traumas
rehabilitation

Additional relevant MeSH terms:
Mental Disorders
Multiple Trauma
Wounds and Injuries

ClinicalTrials.gov processed this record on July 20, 2014