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VIPER: Veterans Integrated Pain Evaluation Research

Sponsor
Defense and Veterans Center for Integrative Pain Management (Other)
Overall Status
Completed
CT.gov ID
NCT01715766
Collaborator
Duke University (Other)
124
Enrollment
1
Location
61
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    124 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    VIPER: Veterans Integrated Pain Evaluation Research- Molecular Subtypes of Chronic Pain Syndromes
    Actual Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    Oct 1, 2013
    Actual Study Completion Date :
    Feb 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Proteomics [1 day]

      To determine which proteins represent circulating qualitative and quantitative biomarkers of pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Walter Reed National Military Medical Center Bethesda Maryland United States 20889

    Sponsors and Collaborators

    • Defense and Veterans Center for Integrative Pain Management
    • Duke University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Defense and Veterans Center for Integrative Pain Management
    ClinicalTrials.gov Identifier:
    NCT01715766
    Other Study ID Numbers:
    • 360806-15
    First Posted:
    Oct 29, 2012
    Last Update Posted:
    Aug 14, 2019
    Last Verified:
    Aug 1, 2019
    Keywords provided by Defense and Veterans Center for Integrative Pain Management
    Proteomics study
    biomarker study of pain

    Study Results

    No Results Posted as of Aug 14, 2019