Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386243
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2006-10-06
Brief Title:
Evaluation of Stepped Care for Chronic Pain in IraqAfghanistan Veterans ESCAPE
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Evaluation of Stepped Care for Chronic Pain in IraqiAfghanistan Veterans
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESCAPE
Brief 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 OIFOEF 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
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
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 FreedomOperation 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 OIFOEF 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None