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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Low Back Pain, Pain, Pain, Intractable

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy
* Behavioral: Pain self-management program
* Drug: Co-Analgesic Therapy
* Drug: Opioid Analgesics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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<br>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<br>* 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.<br>* Other names: Often referred to as CBT.;Behavioral: Pain self-management program<br>* 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.<br>Drug: Co-Analgesic Therapy<br>* 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<br>Drug: Opioid Analgesics<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland-Morris Disability Questionnaire | 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. | at baseline and 9 months | 
| Brief Pain Inventory (Interference) | 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). | Baseline and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-Mental Component Summary (MCS) | 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 | Baseline and 9 months | 
| PHQ-9 Depression | This measure assesses depression symptoms on a 0 to 27 scale with higher scores representing more severe depression | Baseline and 9 months | 
| PTSD Checklist-17 Civilian Version (PCL-C) | 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. | Baseline and 9 months | 
| GAD-7 Anxiety Score | This 7-item scale assesses anxiety symptoms on a 0 to 21 scale with higher scores representing more severe anxiety symptoms | Baseline and 9 months | 
| Pain Catastrophizing Scale (PCS) | 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. | Baseline and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, analgesics, cognitive behavioral therapy, Pain, self-management, stepped care, musculoskeletal pain