N/A N=242 Randomized Treatment

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

Low Back Pain · Pain · Pain, Intractable

Bottom Line

View on ClinicalTrials.gov: NCT00386243 ↗

Enrolled (actual)

242

Serious AEs

2.9%

Results posted

May 2014

Primary outcome: Primary: Roland-Morris Disability Questionnaire — 13.7; 14.0; 12.1; 10.6 scores on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cognitive behavioral therapy (Behavioral); Pain self-management program (Behavioral); Co-Analgesic Therapy (Drug); Opioid Analgesics (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Roland-Morris Disability Questionnaire	13.7; 14.0; 12.1; 10.6	—
PRIMARY Brief Pain Inventory (Interference)	5.4; 5.3; 4.5; 3.8	—
SECONDARY SF-Mental Component Summary (MCS)	41.4; 41.9; 42.4; 42.2	—
SECONDARY PHQ-9 Depression	11.3; 11.05; 10.0; 9.45	—
SECONDARY PTSD Checklist-17 Civilian Version (PCL-C)	25.15; 27.62; 22.71; 24.28	—
SECONDARY GAD-7 Anxiety Score	8.66; 8.95; 7.85; 7.89	—
SECONDARY Pain Catastrophizing Scale (PCS)	21.81; 21.44; 18.40; 16.63	—

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

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

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Data sourced from ClinicalTrials.gov (NCT00386243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.