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

MedlinePlus related topics:

Back Pain

Drug Information available for:

Methadone Methadone hydrochloride Sertraline hydrochloride Sertraline Fluoxetine Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Amitriptyline Amitriptyline hydrochloride Oxycodone Oxycodone hydrochloride Gabapentin Pregabalin Tramadol hydrochloride Tramadol Venlafaxine Venlafaxine hydrochloride Duloxetine Duloxetine hydrochloride Acetaminophen Fluoxetine hydrochloride Nortriptyline Nortriptyline hydrochloride Codeine Codeine phosphate Hydrocodone Hydrocodone bitartrate Cyclobenzaprine Cyclobenzaprine hydrochloride BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

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 ]

Estimated Enrollment:	300
Study Start Date:	December 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention 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.
2: Experimental 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. 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

Contacts


Contact: Kathryn Nyland, BS	(317) 988-4312	Kathryn.Nyland@med.va.gov

Contact: Anne Marie Johnson	(317) 988-4493	Anne.Johnson3@va.gov

Locations


United States, Indiana
	Richard Rodebush VA Medical Center	Recruiting
	Indianapolis, Indiana, United States, 46202-2884
	Contact: Richard L Griffith, MHA FACHE 317-988-2801 richard.griffith@va.gov
	Contact: Jennifer L Myers, MSW (317) 988-4407 Jennifer.Myers@va.gov
	Principal Investigator: Matthew J. Bair, MD MS
	Sub-Investigator: Kurt Kroenke, MD
	Sub-Investigator: Teresa M. Damush, PhD
	Sub-Investigator: Arlene A. Schmid, PhD OTR BS

Sponsors and Collaborators

Department of Veterans Affairs

Investigators


Principal Investigator:	Matthew J. Bair, MD MS	Richard Rodebush VA Medical Center

More Information

Publications:

Damush TM, Weinberger M, Perkins SM, Rao JK, Tierney WM, Qi R, Clark DO. The long-term effects of a self-management program for inner-city primary care patients with acute low back pain. Arch Intern Med. 2003 Nov 24;163(21):2632-8.

Responsible Party:	Department of Veterans Affairs ( Bair, Matthew - Principal Investigator )
Study ID Numbers:	F4437I
First Received:	October 6, 2006
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00386243
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

analgesia

analgesics

cognitive behavioral therapy

Pain

self-management

stepped care

Study placed in the following topic categories:

Pain, Intractable

Morphine

Gabapentin

Tramadol

Oxycodone

Low Back Pain

Pregabalin

Pain

Citalopram

Back Pain

Duloxetine

Codeine

Cyclobenzaprine

Fluoxetine

Signs and Symptoms

Methadone

Nortriptyline

Venlafaxine

Hydrocodone

Amitriptyline

Sertraline

Neurologic Manifestations

Dexetimide

Acetaminophen

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00386243