Clinical trial NCT00386243: Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)
Official title: Evaluation of Stepped Care for Chronic Pain in Iraqi/Afghanistan Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Pain
Pain, Intractable
Keywords: analgesia
analgesics
cognitive behavioral therapy
Pain
self-management
stepped care
musculoskeletal pain
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-10-11
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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 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

Primary outcomes:
measure: Roland-Morris Disability Questionnaire
timeFrame: at baseline and 9 months
measure: Brief Pain Inventory (Interference)
timeFrame: Baseline and 9 months
Secondary outcomes:
measure: SF-Mental Component Summary (MCS)
timeFrame: Baseline and 9 months
measure: PHQ-9 Depression
timeFrame: Baseline and 9 months
measure: PTSD Checklist-17 Civilian Version (PCL-C)
timeFrame: Baseline and 9 months
measure: GAD-7 Anxiety Score
timeFrame: Baseline and 9 months
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline and 9 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard Roudebush VA Medical Center, Indianapolis
state: Indiana
Study officials:
affiliation: Richard Roudebush VA Medical Center
name: Matthew J. Bair, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kroenke K, Bair MJ, Damush TM, Wu J, Hoke S, Sutherland J, Tu W. Optimized antidepressant therapy and pain self-management in primary care patients with depression and musculoskeletal pain: a randomized controlled trial. JAMA. 2009 May 27;301(20):2099-110. doi: 10.1001/jama.2009.723.
citation: Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med. 2016 Jul-Aug;78(6):716-27. doi: 10.1097/PSY.0000000000000322.
citation: Bair MJ, Ang D, Wu J, Outcalt SD, Sargent C, Kempf C, Froman A, Schmid AA, Damush TM, Yu Z, Davis LW, Kroenke K. Evaluation of Stepped Care for Chronic Pain (ESCAPE) in Veterans of the Iraq and Afghanistan Conflicts: A Randomized Clinical Trial. JAMA Intern Med. 2015 May;175(5):682-9. doi: 10.1001/jamainternmed.2015.97.