Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE) (ESCAPE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00386243|
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : May 26, 2014
Last Update Posted : July 3, 2019
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:
- Stepped care is more effective than usual care in reducing pain-related disability
- Stepped care is more effective than usual care in reducing psychological distress
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Pain Pain, Intractable||Behavioral: Cognitive behavioral therapy Behavioral: Pain self-management program Drug: Co-Analgesic Therapy Drug: Opioid Analgesics||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||242 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Stepped Care for Chronic Pain in Iraqi/Afghanistan Veterans|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||September 2012|
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)
- 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).
- 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.
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|
|Principal Investigator:||Matthew J. Bair, MD MS||Richard Roudebush VA Medical Center|