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

Study Primary Completion Date: March 2010

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
  • 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.
• Experimental: 2
  • 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.

Primary Measures

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

Secondary Measures

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Department of Veterans Affairs

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Christy Sargent, BA (317) 988-3838 Christy.Sargent@va.gov

Information obtained from ClinicalTrials.gov on July 02, 2009

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