Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE) - Full Text View

Purpose

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	Intervention
Low Back Pain Pain Pain, Intractable	Behavioral: Cognitive behavioral therapy Behavioral: Pain self-management program Drug: Co-Analgesic Therapy Drug: Opioid Analgesics

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of Stepped Care for Chronic Pain in Iraqi/Afghanistan Veterans

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Chronic Pain

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Pain-related disability (Roland Disability Scale, Disability days and score)Pain severity (Graded Chronic Pain Scale, SF12 Pain Scale, BPI Interference items) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Psychological distress (PHQ-9, MCS score of SF-12, PRIME-MD anxiety, PTSD Checklist (PCL-17)) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
Clinical response (Global Rating of Change) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
Work Function (Work and Health Interview) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
Generic HRQL (SF-12) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]
Pain self-efficacy (Arthritis self-efficacy scale) [ Time Frame: at baseline, 3, 6, and 9 months ] [ Designated as safety issue: No ]

Enrollment:	242
Study Start Date:	December 2007
Study Completion Date:	September 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Arm 1 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: Arm 2 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)

Arms

Assigned Interventions

No Intervention: Arm 1

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: Arm 2

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)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386243

Locations

United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Matthew J. Bair, MD MS

Richard Roudebush VA Medical Center

More Information

Publications:

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.

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00386243 History of Changes
Obsolete Identifiers:	NCT00449475
Other Study ID Numbers:	F4437-I
Study First Received:	October 6, 2006
Last Updated:	November 27, 2012
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

analgesia
analgesics
cognitive behavioral therapy
Pain

self-management
stepped care
musculoskeletal pain

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain, Intractable
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics

Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 16, 2013