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VIPER: Veterans Integrated Pain Evaluation Research

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier:
NCT01715766
First received: October 17, 2012
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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
Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: VIPER: Veterans Integrated Pain Evaluation Research- Molecular Subtypes of Chronic Pain Syndromes

Further study details as provided by Defense and Veterans Center for Integrative Pain Management:

Primary Outcome Measures:
  • Proteomics [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    To determine which proteins represent circulating qualitative and quantitative biomarkers of pain.


Biospecimen Retention:   Samples With DNA

Blood draw will consist of, two BD™ P100 tubes (2x8.5mL=17mL) where the plasma will be separated by centrifuge then placed in a -80ºC freezer. Two RNA tubes (2 x 2.5mL=5mL) and one DNA tube (8.5mL) will be place first, in a -20ºC freezer for 24-36 hours then moved to a -80ºC freezer. All the blood samples will remain in a -80ºC freezer at the Department of Clinical Investigation(DCI) laboratory until they are sent to Duke University after every 8 subjects.


Enrollment: 124
Study Start Date: January 2012
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male and female active duty military personnel age 18 years and older presenting with the diagnosis of amputation of 1 limb in the previous 18 months. At least 3 months must have passed since the first amputation procedure.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715766

Locations
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Defense and Veterans Center for Integrative Pain Management
Duke University
  More Information

No publications provided

Responsible Party: Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier: NCT01715766     History of Changes
Other Study ID Numbers: 360806-15
Study First Received: October 17, 2012
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Defense and Veterans Center for Integrative Pain Management:
Proteomics study
biomarker study of pain

ClinicalTrials.gov processed this record on November 20, 2014