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Completed

NCT Number: NCT00386243

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richard Roudebush VA Medical Center, Indianapolis

Indianapolis, Indiana, 46202-2884, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Often referred to as "CBT."

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.

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

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)

Primary outcomes

  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 outcomes

  1. SF-Mental Component Summary (MCS)

    Time frame: Baseline and 9 months

    This scale provides a measure of mental health quality of life. It is measure on a 0 to 100 scale with higher scores representing better mental health

  2. PHQ-9 Depression

    Time frame: Baseline and 9 months

    This measure assesses depression symptoms on a 0 to 27 scale with higher scores representing more severe depression

  3. PTSD Checklist-17 Civilian Version (PCL-C)

    Time frame: Baseline and 9 months

    The PCL-17 is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Two versions of the PCL exist: PCL-Military and PCL-Civilian.We used the PCL-Civilian version because it addresses the broadest range of possible events as the traumatic stressor. The PCL-C has demonstrated strong reliability and validity in multiple samples. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". Higher scores represent more severe PTSD symptoms.

  4. GAD-7 Anxiety Score

    Time frame: Baseline and 9 months

    This 7-item scale assesses anxiety symptoms on a 0 to 21 scale with higher scores representing more severe anxiety symptoms

  5. Pain Catastrophizing Scale (PCS)

    Time frame: Baseline and 9 months

    The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0-52 with higher scores representing more pain catastrophizing.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Evaluation of Stepped Care for Chronic Pain in Iraqi/Afghanistan Veterans

Acronym: ESCAPE

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 11, 2006
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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