VIPER: Veterans Integrated Pain Evaluation Research | NCT01715766

Studies
VIPER: Veterans Integrated Pain Evaluation Research

NCT01715766

Sponsor

Defense and Veterans Center for Integrative Pain Management

Status

Completed

Last Update Posted

Aug 14, 2019Actual

Enrollment

124Actual

Phase

Not provided

Conditions

Pain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012Actual

Primary Completion Date

Oct 2013Actual

Completion Date

Feb 2017Actual

First Submitted Date

Oct 17, 2012

First Submission Date that Met QC Criteria

Oct 25, 2012

First Posted Date

Oct 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2019

Last Update Posted Date

Aug 14, 2019Actual

Name	Class
Duke University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

124Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proteomics	To determine which proteins represent circulating qualitative and quantitative biomarkers of pain.	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Walter Reed National Military Medical Center		Bethesda	Maryland	20889	United States

ID	Term
D010146	Pain

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Description

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.