Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)

VA Office of Research and Development

Status: Completed

Conditions: Pain, Intractable; Pain; Low Back Pain

Treatments: Behavioral: Pain self-management program; Drug: Co-Analgesic Therapy; Behavioral: Cognitive behavioral therapy; Drug: Opioid Analgesics

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00386243

F4437-I

Details and patient eligibility

About

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

Full 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.

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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.

Stepped Care

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive behavioral therapy

Drug: Co-Analgesic Therapy

Behavioral: Pain self-management program

Drug: Opioid Analgesics