VIPER: Veterans Integrated Pain Evaluation Research

Pain Clinical Trial

— VIPER  

Official title:

VIPER: Veterans Integrated Pain Evaluation Research- Molecular Subtypes of Chronic Pain Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715766
• Other study ID #: 360806-15
• Status: Completed
• Start date: January 2012
• Est. completion date: February 2017

Study information

• Verified date: August 2019
• Source: Defense and Veterans Center for Integrative Pain Management
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 2017
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Defense and Veterans Center for Integrative Pain Management	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteomics	To determine which proteins represent circulating qualitative and quantitative biomarkers of pain.	1 day