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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00386243
First received: October 6, 2006
Last updated: September 23, 2013
Last verified: September 2013
  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:

  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

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:


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)

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
Investigators
Principal Investigator: Matthew J. Bair, MD MS Richard Roudebush VA Medical Center
  More Information

Publications:
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: September 23, 2013
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 April 21, 2014