Official Title: “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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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.

Primary:

• Pain-related disability (Roland Disability Scale, Disability days and score)Pain severity (Graded Chronic Pain Scale, SF12 Pain Scale, BPI Interference items) at baseline, 3, 6, and 9 months No

Secondary:

• Psychological distress (PHQ-9, MCS score of SF-12, PRIME-MD anxiety, PTSD Checklist (PCL-17)) at baseline, 3, 6, and 9 months No
• Clinical response (Global Rating of Change) at baseline, 3, 6, and 9 months No
• Work Function (Work and Health Interview) at baseline, 3, 6, and 9 months No
• Generic HRQL (SF-12) at baseline, 3, 6, and 9 months No
• Pain self-efficacy (Arthritis self-efficacy scale) at baseline, 3, 6, and 9 months No

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

Lead Sponsor: Department of Veterans Affairs

Richard Rodebush VA Medical Center

Indianapolis Indiana 46202-2884 United States

Overall Clinical Trial Officials and Contacts

Matthew J. Bair, MD MS Principal Investigator Richard Rodebush VA Medical Center  

Overall Contact: Kathryn Nyland, BS (317) 988-4312 knyland@iupui.edu

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00386243

Study ID Number: F4437I

ClinicalTrials.gov Identifier: NCT00386243

Health Authority: United States: Federal Government