Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low Back Pain; Pain; Pain, Intractable
Intervention: Cognitive behavioral therapy (Behavioral); Pain self-management program (Behavioral); Co-Analgesic Therapy (Drug); Opioid Analgesics (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Matthew J. Bair, MD MS, Principal Investigator, Affiliation: Richard Rodebush VA Medical Center
Overall contact:
Christy Sargent, BA, Phone: (317) 988-3838, Email: Christy.Sargent@va.gov
Summary
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
Clinical Details
Official title: Evaluation of Stepped Care for Chronic Pain in Iraqi/Afghanistan Veterans
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Pain-related disability (Roland Disability Scale, Disability days and score)Pain severity (Graded Chronic Pain Scale, SF12 Pain Scale, BPI Interference items)
Secondary outcome: Psychological distress (PHQ-9, MCS score of SF-12, PRIME-MD anxiety, PTSD Checklist (PCL-17))Clinical response (Global Rating of Change) Work Function (Work and Health Interview) Generic HRQL (SF-12) Pain self-efficacy (Arthritis self-efficacy scale)
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Christy Sargent, BA, Phone: (317) 988-3838, Email: Christy.Sargent@va.gov
Richard Rodebush VA Medical Center, Indianapolis, Indiana 46202-2884, United States; Recruiting
Matthew J Bair, MD MS, Phone: 317-988-2058, Email: Matthew.Bair@va.gov
Angela J Harris, BS, Phone: (317) 988-3153, Email: Angela.Harris6@va.gov
Matthew J. Bair, MD MS, Principal Investigator
Kurt Kroenke, MD, Sub-Investigator
Teresa M. Damush, PhD, Sub-Investigator
Arlene A. Schmid, PhD OTR BS, Sub-Investigator
Additional Information
Related publications: 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.
Starting date: December 2007
Ending date: July 2010
Last updated: June 17, 2009
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