VIPER: Veterans Integrated Pain Evaluation Research

Completed

• Conditions: Pain

• Registration Number: NCT01715766
• Lead Sponsor: Defense and Veterans Center for Integrative Pain Management

Brief Summary

The purpose of the study is to learn about the causes of different types of pain that can occur in people who have had an amputation. By gathering information through blood tests, photographs, a nerve test, and questionnaires, we hope to de-code how each individual's special characteristics affect the type and amount of pain they experience in their amputated limb.

Detailed Description

Studies have already shown that pain following amputation might be caused by differences in a person's genes. This study may help us find out how genes affect the way you feel pain and why you may feel more or less or different kinds of pain than another person with a similar amputation. What we learn in this research study may lead to discoveries as to why some painkillers work better for some people than others.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-29
• Primary Completion: 2013-10
• Study Completion: 2017-02
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Male and female active duty military personnel age 18 years and older undergoing treatment at WRAMC and future WRNMMC with the diagnosis of post injury amputation of 1 limb, more than 3 but less than 18 months prior to enrollment. In particular, phantom limb pain patients will be included

Exclusion Criteria

• Severe Traumatic Brain Injury (Primary major head trauma and diagnosis of traumatic brain injury resulting in documented, permanent or prolonged cognitive deficits that would preclude participation in the study (i.e. decreased intellectual capacity, marked memory deficits, or inability to communicate verbally or in writing)
• Significant cognitive deficits that would preclude participation in the study.
• Substantial hearing loss without alternative means of communication.
• Documented spinal cord injury with permanent or persistent deficits.
• Diagnosis of fibromyalgia or other chronic pain syndrome such as chronic headaches.
• Evidence of ongoing tissue damage pain, infection, bone spur, or poorly fitting prosthesis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proteomics	1 day	To determine which proteins represent circulating qualitative and quantitative biomarkers of pain.

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States