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

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ClinicalTrials.gov Identifier: NCT00386243
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : May 26, 2014
Last Update Posted : May 26, 2014
Information provided by (Responsible Party):

Study Description
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. 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

Condition or disease Intervention/treatment
Low Back Pain Pain Pain, Intractable Behavioral: Cognitive behavioral therapy Behavioral: Pain self-management program Drug: Co-Analgesic Therapy Drug: Opioid Analgesics

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Stepped Care for Chronic Pain in Iraqi/Afghanistan Veterans
Study Start Date : December 2007
Primary Completion Date : May 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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)

Outcome Measures

Primary Outcome Measures :
  1. Roland-Morris Disability Questionnaire [ Time Frame: at baseline and 9 months ]
    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.

  2. Brief Pain Inventory (Interference) [ Time Frame: Baseline and 9 months ]
    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).

Secondary Outcome Measures :
  1. 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 ]
  2. Clinical Response (Global Rating of Change) [ Time Frame: at baseline, 3, 6, and 9 months ]
  3. Work Function (Work and Health Interview) [ Time Frame: at baseline, 3, 6, and 9 months ]
  4. Generic HRQL (SF-12) [ Time Frame: at baseline, 3, 6, and 9 months ]
  5. Pain Self-efficacy (Arthritis Self-efficacy Scale) [ Time Frame: at baseline, 3, 6, and 9 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386243

United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Matthew J. Bair, MD MS Richard Roudebush VA Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00386243     History of Changes
Obsolete Identifiers: NCT00449475
Other Study ID Numbers: F4437-I
First Posted: October 11, 2006    Key Record Dates
Results First Posted: May 26, 2014
Last Update Posted: May 26, 2014
Last Verified: April 2014

Keywords provided by VA Office of Research and Development:
cognitive behavioral therapy
stepped care
musculoskeletal pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Chronic Pain
Pain, Intractable
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants