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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00386243
First received: October 6, 2006
Last updated: April 29, 2014
Last verified: April 2014

October 6, 2006
April 29, 2014
December 2007
May 2012   (final data collection date for primary outcome measure)
  • Roland-Morris Disability Questionnaire [ Time Frame: at baseline and 9 months ] [ Designated as safety issue: No ]
    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.
  • Brief Pain Inventory (Interference) [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: No ]
    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).
  • Pain-related disability (Roland Disability Scale, Disability days and score); at baseline, 3, 6, and 9 months.
  • Pain severity (Graded Chronic Pain Scale, SF12 Pain Scale, BPI Interference items); at baseline, 3, 6, and 9 months.
Complete list of historical versions of study NCT00386243 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Clinical Response (Global Rating of Change) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
  • Work Function (Work and Health Interview) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
  • Generic HRQL (SF-12) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
  • Pain Self-efficacy (Arthritis Self-efficacy Scale) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
  • Psychological distress (PHQ-9, MCS score of SF-12, PRIME-MD anxiety, PTSD Checklist (PCL-17)); at baseline, 3, 6, and 9 months.
  • Clinical response (Global Rating of Change); at baseline, 3, 6, and 9 months.
  • Work Function (Work and Health Interview); at baseline, 3, 6, and 9 months.
  • Generic HRQL (SF-12); at baseline, 6, and 9 months.
  • Pain self-efficacy (Arthritis self-efficacy scale); at baseline, 3, and 9 months.
  • Pain beliefs (Pain Catastrophizing Scale); at baseline, 6, and 9 months.
  • Pain coping (Pain Stages of Change); at baseline, 6, and 9 months.
  • Somatization (PHQ-15); at baseline, 6, and 9 months.
  • Stressors (PHQ stressor scale); at baseline, 6, and 9 months.
  • Satisfaction (Pain-specific satisfaction); at 3, 6, and 9 months.
Not Provided
Not Provided
 
Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Low Back Pain
  • Pain
  • Pain, Intractable
  • 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.
    Other Name: Often referred to as "CBT."
  • 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)
  • No Intervention: Usual Care
    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: Stepped Care
    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.
    Interventions:
    • Behavioral: Cognitive behavioral therapy
    • Behavioral: Pain self-management program
    • Drug: Co-Analgesic Therapy
    • Drug: Opioid Analgesics
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
242
September 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00386243
F4437-I
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Matthew J. Bair, MD MS Richard Roudebush VA Medical Center
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP