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

NCT00645970 | Completed Results

• 1 other identifier: SDR 07-047
• Study Type: observational
• Target: 359
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Keywords

chronic pain; combat injuries; pain assessment; multiple traumas; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scales of Pain Over Past Week (11 Point Likert Scale)

  Numeric Pain Rating Scale is a self-report measure of "usual" (average) pain intensity over the last week; response options range from "no pain" (0) to "worst pain imaginable" (10). A score \>3 indicates moderate-to-severe pain.

  Baseline, 6 months, 1 year

Study Arms (1)

Group 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• see above.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Related Publications (11)

• Buckenmaier III CC, Gallagher RM, Cahana A, Clark ME, Davis SA, Brandon-Edwards H, Griffith S, Houston JS, Jankovich E, Kurihara C, Mackey S, Rupprecht C, Spevak C. War on Pain: New Strategies in Pain Management for Military Personnel and Veterans. Federal practitioner : for the health care professionals of the VA, DoD, and PHS. 2011 Jan 1; 28(Suppl 2):1-16.

  BACKGROUND

• Kalra R, Clark ME, Scholten JD, Murphy JL, Clements KL. Managing pain among returning service members. Federal practitioner : for the health care professionals of the VA, DoD, and PHS. 2008 Jan 1; 25:36-45.

  BACKGROUND

• Lew HL, Otis JD, Tun C, Kerns RD, Clark ME, Cifu DX. Prevalence of chronic pain, posttraumatic stress disorder, and persistent postconcussive symptoms in OIF/OEF veterans: polytrauma clinical triad. J Rehabil Res Dev. 2009;46(6):697-702. doi: 10.1682/jrrd.2009.01.0006.

  PMID: 20104399 RESULT

• Walker RL, Clark ME, Nampiaparampil DE, McIlvried L, Gold MS, Okonkwo R, Kerns RD. The hazards of war: blast injury headache. J Pain. 2010 Apr;11(4):297-302. doi: 10.1016/j.jpain.2009.12.001. No abstract available.

  PMID: 20350705 RESULT

• Dobscha SK, Clark ME, Morasco BJ, Freeman M, Campbell R, Helfand M. Systematic review of the literature on pain in patients with polytrauma including traumatic brain injury. Pain Med. 2009 Oct;10(7):1200-17. doi: 10.1111/j.1526-4637.2009.00721.x.

  PMID: 19818031 RESULT

• Gironda RJ, Clark ME, Ruff RL, Chait S, Craine M, Walker R, Scholten J. Traumatic brain injury, polytrauma, and pain: challenges and treatment strategies for the polytrauma rehabilitation. Rehabil Psychol. 2009 Aug;54(3):247-58. doi: 10.1037/a0016906.

  PMID: 19702423 RESULT

• Clark ME. Cost-effectiveness of multidisciplinary pain treatment: are we there yet? Pain Med. 2009 Jul-Aug;10(5):778-9. doi: 10.1111/j.1526-4637.2009.00659.x. No abstract available.

  PMID: 19691153 RESULT

• Clark ME, Scholten JD, Walker RL, Gironda RJ. Assessment and treatment of pain associated with combat-related polytrauma. Pain Med. 2009 Apr;10(3):456-69. doi: 10.1111/j.1526-4637.2009.00589.x.

  PMID: 19416437 RESULT

• Clark ME, Walker RL, Gironda RJ, Scholten JD. Comparison of pain and emotional symptoms in soldiers with polytrauma: unique aspects of blast exposure. Pain Med. 2009 Apr;10(3):447-55. doi: 10.1111/j.1526-4637.2009.00590.x.

  PMID: 19416436 RESULT

• Clark ME, Hooten WM, Sanders SH. Interdisciplinary pain rehabilitation: current challenges and future opportunities. Pain Med. 2011 Jan;12(1):152-3. doi: 10.1111/j.1526-4637.2010.01034.x. No abstract available.

  PMID: 21223493 RESULT

• Walker RL, Clark ME, Sanders SH. The Postdeployment multi-symptom disorder: An emerging syndrome in need of a new treatment paradigm. Psychological Services. 2010 Aug 1; 7(3):136-147.

  RESULT

MeSH Terms

Conditions

Chronic Pain; Multiple Trauma

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Results Point of Contact

• Title: Kristin Phillips
• Organization: James A. Haley Veterans' Hospital

kristin.phillips3@va.gov

813-972-2000

Study Officials

• Michael E Clark, PhD MA

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 28, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 15, 2015
• Results First Posted: December 30, 2014

Record last verified: 2015-05

Locations

US (1)