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

Pain Clinical Trial

— ESCAPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386243
• Other study ID #: F4437-I
• Status: Completed
• Phase: N/A
• Start date: December 2007
• Est. completion date: September 2012

Study information

• Verified date: May 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Other known NCT identifiers

• NCT00449475

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: September 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain
• Pain
• Pain, Intractable

Intervention

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.
• 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
• 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)

Locations

Country	Name	City	State
United States	Richard Roudebush VA Medical Center, Indianapolis	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kroenke K, Bair MJ, Damush TM, Wu J, Hoke S, Sutherland J, Tu W. Optimized antidepressant therapy and pain self-management in primary care patients with depression and musculoskeletal pain: a randomized controlled trial. JAMA. 2009 May 27;301(20):2099-110 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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