VIPER: Veterans Integrated Pain Evaluation Research

NCT01715766 | Completed

• 1 other identifier: 360806-15
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Proteomics study; biomarker study of pain

Outcome Measures

Primary Outcomes (1)

• Proteomics

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

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Defense and Veterans Center for Integrative Pain Management: lead
• Duke University: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

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.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 29, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: February 1, 2017
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

US (1)