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Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)
This study is currently recruiting participants.
Study NCT00386243   Information provided by Department of Veterans Affairs
First Received: October 6, 2006   Last Updated: June 17, 2009   History of Changes

October 6, 2006
June 17, 2009
December 2007
March 2010   (final data collection date for primary outcome measure)
Pain-related disability (Roland Disability Scale, Disability days and score)Pain severity (Graded Chronic Pain Scale, SF12 Pain Scale, BPI Interference items) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
  • Pain-related disability (Roland Disability Scale, Disability days and score); at baseline, 3, 6, and 9 months.
  • Pain severity (Graded Chronic Pain Scale, SF12 Pain Scale, BPI Interference items); at baseline, 3, 6, and 9 months.
Complete list of historical versions of study NCT00386243 on ClinicalTrials.gov Archive Site
  • Psychological distress (PHQ-9, MCS score of SF-12, PRIME-MD anxiety, PTSD Checklist (PCL-17)) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
  • Clinical response (Global Rating of Change) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
  • Work Function (Work and Health Interview) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
  • Generic HRQL (SF-12) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
  • Pain self-efficacy (Arthritis self-efficacy scale) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
  • Psychological distress (PHQ-9, MCS score of SF-12, PRIME-MD anxiety, PTSD Checklist (PCL-17)); at baseline, 3, 6, and 9 months.
  • Clinical response (Global Rating of Change); at baseline, 3, 6, and 9 months.
  • Work Function (Work and Health Interview); at baseline, 3, 6, and 9 months.
  • Generic HRQL (SF-12); at baseline, 6, and 9 months.
  • Pain self-efficacy (Arthritis self-efficacy scale); at baseline, 3, and 9 months.
  • Pain beliefs (Pain Catastrophizing Scale); at baseline, 6, and 9 months.
  • Pain coping (Pain Stages of Change); at baseline, 6, and 9 months.
  • Somatization (PHQ-15); at baseline, 6, and 9 months.
  • Stressors (PHQ stressor scale); at baseline, 6, and 9 months.
  • Satisfaction (Pain-specific satisfaction); at 3, 6, and 9 months.
 
Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)
Evaluation of Stepped Care for Chronic Pain in Iraqi/Afghanistan Veterans

The purpose of this study is to determine if a stepped-care intervention makes pain symptoms better and reduces activity limitations because of pain. Our two primary hypotheses are that in OIF/OEF veterans with chronic pain:

  1. Stepped care is more effective than usual care in reducing pain-related disability
  2. Stepped care is more effective than usual care in reducing psychological distress

Through the Evaluation of Stepped Care for Chronic Pain (ESCAPE) trial we aim to develop and test a stepped-care intervention to improve functional and work-related outcomes in Operation Iraqi Freedom/Operation Enduring Freedom veterans with chronic musculoskeletal pain. Stepped-care involves starting with lower intensity, less costly treatments initially (Step 1) and "stepping up" to more intensive, costly, or complex treatments in patients with inadequate response (Step 2). The study design will be a randomized controlled trial. The stepped care approach will involve 12 weeks of a pain self-management program in Step 1 followed by 12 weeks of brief cognitive behavioral therapy in participants with inadequate improvement in pain-related disability (Step 2). Patients treated in usual care will be the control group. Thus, the primary objective of the ESCAPE trial is to conduct a randomized controlled trial to compare the effectiveness of a stepped care intervention vs. usual care in OIF/OEF veterans with chronic and disabling musculoskeletal pain and evaluate the impact of this intervention on pain-related disability, work function, psychological distress, and secondary outcomes.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Low Back Pain
  • Pain
  • Pain, Intractable
  • Behavioral: Cognitive behavioral therapy
  • Behavioral: Pain self-management program
  • Drug: Co-Analgesic Therapy
  • Drug: Opioid Analgesics
  • No Intervention: Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
  • Experimental: Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Damush TM, Weinberger M, Perkins SM, Rao JK, Tierney WM, Qi R, Clark DO. The long-term effects of a self-management program for inner-city primary care patients with acute low back pain. Arch Intern Med. 2003 Nov 24;163(21):2632-8.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
300
July 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • have musculoskeletal pain of the low back, cervical spine, or extremities
  • have chronic pain (>3 months duration)
  • have moderate functional impairment
  • have access to a working telephone
  • Indianapolis Roudebush VA Medical Center patient or Walter Reed Army Medical Center patient
  • willing to travel at least once to study site

Exclusion Criteria:

  • prior back or cervical spine surgery or surgery pending
  • active psychosis
  • incompetent for interview
  • severe impairment of hearing or speech
  • active suicidal ideation
  • current alcohol or other substance dependence or abuse
Both
18 Years and older
No
Contact: Christy Sargent, BA (317) 988-3838 Christy.Sargent@va.gov
Contact: Anne Marie Johnson (317) 988-4493 Anne.Johnson3@va.gov
United States
 
NCT00386243
Bair, Matthew - Principal Investigator, Department of Veterans Affairs
F4437I
Department of Veterans Affairs
 
Principal Investigator: Matthew J. Bair, MD MS Richard Rodebush VA Medical Center
Department of Veterans Affairs
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP