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Trial record 38 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

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 : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE October 6, 2006
First Posted Date  ICMJE October 11, 2006
Results First Submitted Date  ICMJE September 25, 2013
Results First Posted Date  ICMJE May 26, 2014
Last Update Posted Date July 3, 2019
Study Start Date  ICMJE December 2007
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2006)
  • 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.
Change History Complete list of historical versions of study NCT00386243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • 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
  • 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
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2006)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)
Official Title  ICMJE Evaluation of Stepped Care for Chronic Pain in Iraqi/Afghanistan Veterans
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Low Back Pain
  • Pain
  • Pain, Intractable
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2012)
242
Original Enrollment  ICMJE
 (submitted: October 10, 2006)
240
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00386243
Other Study ID Numbers  ICMJE F4437-I
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew J. Bair, MD MS Richard Roudebush VA Medical Center
PRS Account VA Office of Research and Development
Verification Date May 2019

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