NCT03018782

Brief Summary

The investigators are evaluating refugee torture survivors who are receiving services at the Weill Cornell Center for Human Rights. There are two research questions in this study: if the current standard of care results in the under or missed diagnosis of pain and pain syndromes, and if a validated pain screening tool can supplement the current standard protocol used in the assessments of survivors of torture.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

2.5 years

First QC Date

December 17, 2016

Last Update Submit

July 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with chronic pain or pain syndromes as assessed by a non-invasive pain evaluation conducted by a pain physician

    Evaluate whether or not current standard protocols for the assessment of survivors of torture result in under or missed diagnosis of pain and pain syndromes that are identifiable by a pain specialist physician

    Day 1

Secondary Outcomes (1)

  • Number of participants with chronic pain or pain syndromes as assessed by the Brief Pain Inventory (BPI) Short Form

    Day 1

Study Arms (1)

Brief Pain Inventory Short Form

OTHER

Completes the Brief Pain Inventory Short Form

Other: Brief Pain Inventory Short Form

Interventions

Brief Pain Inventory Short Form

Brief Pain Inventory Short Form

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women from any country over the age of 18
  • refugees receiving services from the Weill Cornell Center for Human Rights

You may not qualify if:

  • Have not experienced torture
  • Subjects whose representative does not believe that they are a good candidate for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • Kaur G, Weinberg R, Milewski AR, Huynh S, Mauer E, Hemmings HC Jr, Pryor KO. Chronic pain diagnosis in refugee torture survivors: A prospective, blinded diagnostic accuracy study. PLoS Med. 2020 Jun 5;17(6):e1003108. doi: 10.1371/journal.pmed.1003108. eCollection 2020 Jun.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gunisha Kaur, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR
  • Eliana Weinstein, BS

    Weill Medical College of Cornell University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2016

First Posted

January 12, 2017

Study Start

January 1, 2017

Primary Completion

June 21, 2019

Study Completion

June 21, 2019

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available to other researchers

Locations