Back to resultsPain Screening in Refugee Survivors of Torture
Primary Purpose
Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Pain Inventory Short Form
Sponsored by
About this trial
This is an interventional diagnostic trial for Pain, Chronic
Eligibility Criteria
Inclusion Criteria:
- Men and women from any country over the age of 18
- refugees receiving services from the Weill Cornell Center for Human Rights
Exclusion Criteria:
- Have not experienced torture
- Subjects whose representative does not believe that they are a good candidate for the study
Sites / Locations
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Brief Pain Inventory Short Form
Arm Description
Completes the Brief Pain Inventory Short Form
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of participants with chronic pain or pain syndromes as assessed by the Brief Pain Inventory (BPI) Short Form
Evaluate whether or not a validated pain screening tool can supplement the current standard protocols used in the assessment of survivors of torture.
Full Information
NCT ID
NCT03018782
First Posted
December 17, 2016
Last Updated
July 17, 2021
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT03018782
Brief Title
Pain Screening in Refugee Survivors of Torture
Official Title
The Implementation of a Novel Pain-screening Tool in the Diagnoses of Pain Symptoms and Syndromes in Refugee Survivors of Torture
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
June 21, 2019 (Actual)
Study Completion Date
June 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The research plan consists of three components:
The Weill Cornell Center for Human Rights will coordinate with the research team regarding eligible subjects.
Researchers will contact potential subjects utilizing interpreter services.
Interested participants will be scheduled for an appointment for an examination by a pain physician and to complete the Brief Pain Inventory.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief Pain Inventory Short Form
Arm Type
Other
Arm Description
Completes the Brief Pain Inventory Short Form
Intervention Type
Other
Intervention Name(s)
Brief Pain Inventory Short Form
Intervention Description
Brief Pain Inventory Short Form
Primary Outcome Measure Information:
Title
Number of participants with chronic pain or pain syndromes as assessed by a non-invasive pain evaluation conducted by a pain physician
Description
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
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of participants with chronic pain or pain syndromes as assessed by the Brief Pain Inventory (BPI) Short Form
Description
Evaluate whether or not a validated pain screening tool can supplement the current standard protocols used in the assessment of survivors of torture.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women from any country over the age of 18
refugees receiving services from the Weill Cornell Center for Human Rights
Exclusion Criteria:
Have not experienced torture
Subjects whose representative does not believe that they are a good candidate for the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunisha Kaur, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eliana Weinstein, BS
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Study Director
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers
Citations:
PubMed Identifier
32502219
Citation
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.
Results Reference
derived
Learn more about this trial
Pain Screening in Refugee Survivors of Torture
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