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

NCT00386243 | Completed Results DMC

• 1 other identifier: F4437-I
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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. 1.Stepped care is more effective than usual care in reducing pain-related disability
2. 2.Stepped care is more effective than usual care in reducing psychological distress

Conditions

Low Back Pain; Pain; Pain, Intractable

Keywords

analgesia; analgesics; cognitive behavioral therapy; Pain; self-management; stepped care; musculoskeletal pain

Outcome Measures

Primary Outcomes (2)

• Roland-Morris Disability Questionnaire

  This is a 24-item pain specific disability questionnaire consisting of 24 questions which are related specifically to physical functions that are likely to be affected by back pain. The questionnaire is scored by adding up the number of items checked by the subject (0-24 range). Greater levels of disability are reflected by higher numbers.

  at baseline and 9 months

• Brief Pain Inventory (Interference)

  This is an 7-item measure that provides scores for pain-related functional impairment. The seven (7) pain interference items are rated on a simple numeric rating scale from 0-10. On the scale 0 represents "no interference" and 10 is "completely interferes". The pain interference score is achieved by taking the total of all seven (7) scores and dividing it by the number of items (7).

  Baseline and 9 months

Secondary Outcomes (5)

• SF-Mental Component Summary (MCS)

  Baseline and 9 months

• PHQ-9 Depression

  Baseline and 9 months

• PTSD Checklist-17 Civilian Version (PCL-C)

  Baseline and 9 months

• GAD-7 Anxiety Score

  Baseline and 9 months

• Pain Catastrophizing Scale (PCS)

  Baseline and 9 months

Study Arms (2)

Usual Care

NO INTERVENTION

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

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.

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

Interventions

Cognitive behavioral therapy BEHAVIORAL

Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.

Also known as: Often referred to as "CBT."

Stepped Care

Pain self-management program BEHAVIORAL

The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.

Stepped Care

Co-Analgesic Therapy DRUG

Amitriptyline, start at 10-25, titrate to 100 mg Nortriptyline, start at 10-25, titrate to 100 mg Gabapentin, titrate up to 900-1200 tid venlafaxine, carbemazepine, duloxetine, and/or pregabalin Cyclobenzaprine, titrate to 10 mg TID fluoxetine, sertraline, citalopram

Stepped Care

Opioid Analgesics DRUG

Tramadol 50 mg BID or TID and titrate to 100 mg QID Acetaminophen/codeine (300mg/30mg). Take 1 or 2 tablets qid prn pain Acetaminophen/hydrocodone (500mg/5mg). Take 1 or 2 tablets qid prn pain Acetaminophen/oxycodone (500mg/5mg). Take 1 or 2 tablets qid prn pain Morphine SR (30mg). Start at 30 mg twice a day (titrate up to 240mg/day if needed) Methadone (5-10mg). Start at 5mg bid; titrate 10mg tid (max 20mg tid)

Stepped Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Richard Roudebush VA Medical Center, Indianapolis

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (3)

• 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.

  PMID: 19470987 RESULT

• 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.

  PMID: 27187854 DERIVED

• 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.

  PMID: 25751701 DERIVED

MeSH Terms

Conditions

Low Back Pain; Pain; Pain, Intractable; Agnosia; Musculoskeletal Pain

Interventions

Cognitive Behavioral Therapy; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Limitations and Caveats

Single VA Center; May not generalize to non-VA samples

Results Point of Contact

• Title: Matthew J. Bair, MD MS
• Organization: Center on Implementing Evidence Based Practice

mbair@iupui.edu

317-988-2058

Study Officials

• Matthew J. Bair, MD MS

  Richard Roudebush VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 11, 2006
• Study Start: December 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 5, 2019
• Results First Posted: May 26, 2014

Record last verified: 2019-05

Locations

US (1)