Evaluation of Stepped Care for Chronic Pain in Iraq and Afghanistan Veterans
Information source: Indiana University
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Non-opioid analgesic therapy (Drug); Pain Self-Management (Behavioral); Cognitive Behavioral Therapy (Behavioral); Co-Analgesic Therapy (Drug); Opioid analgesics (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Indiana University School of Medicine Official(s) and/or principal investigator(s):
Matthew J Bair, MD, MS, Principal Investigator, Affiliation: R. L. Roudebush VA Medical Center
Overall contact:
Kate Nyland, BS, Phone: 317-988-4312, Email: knyland@iupui.edu
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 Iraq and Afghanistan Veterans Trial
Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: Disability/Functional impairment (Roland Morris Disability Scale)Pain level (Graded Chronic Pain Scale)
Secondary outcome: Psychological distress (PHQ-9)
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
Kate Nyland, BS, Phone: 317-988-4312, Email: knyland@iupui.edu
R.L. Roudebush VA Medical Center, Indianapolis, Indiana 46202, United States; Recruiting
Kate Nyland, BS, Phone: 317-988-4312, Email: knyland@iupui.edu
Matthew J Bair, MD, MS, Principal Investigator
Additional Information
Starting date: December 2007
Ending date: July 2010
Last updated: January 29, 2008
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