VIPER: Veterans Integrated Pain Evaluation Research

NCT ID: NCT01715766

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-02-28

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Defense and Veterans Center for Integrative Pain Management

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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360806-15

Identifier Type: -

Identifier Source: org_study_id

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