CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 242 enrolled
Drug / intervention
Co-Analgesic Therapy +3 moredrug
Likely dose
Co-Analgesic Therapy 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00386243
NCT00386243N/ACompleted

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

VA Office of Research and Development·interventional·Posted Oct 11, 2006·Updated Jul 5, 2019

In Brief

A clinical study evaluating Cognitive behavioral therapy, Pain self-management program, and 2 other interventions for Low Back Pain and 2 related conditions. Completed, enrolled 242 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 11, 2006
Enrollment StartDec 1, 2007
Primary CompletionMay 1, 2012
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 19.7 years ago

Interventions

Cognitive behavioral therapybehavioral

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 programbehavioral

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.

Co-Analgesic Therapydrug

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 Analgesicsdrug

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)