Pain, ChronicNCT03018782
Pain Screening in Refugee Survivors of Torture
A study testing Brief Pain Inventory Short Form in people with Pain, Chronic, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Brief Pain Inventory Short Form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 21 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women from any country over the age of 18
- refugees receiving services from the Weill Cornell Center for Human Rights
Who cannot join
- Have not experienced torture
- Subjects whose representative does not believe that they are a good candidate for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Implementation of a Novel Pain-screening Tool in the Diagnoses of Pain Symptoms and Syndromes in Refugee Survivors of Torture
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.
Read the 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.
- Conditions
- Pain, Chronic
- Being tested
- Brief Pain Inventory Short Form
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Pain Inventory Short FormOther
Brief Pain Inventory Short Form
| Study group | Role | What they receive |
|---|---|---|
| Brief Pain Inventory Short Form | Other | Completes the Brief Pain Inventory Short Form Receives: Other: Brief Pain Inventory Short Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunisha Kaur, MD, Principal investigator, Weill Medical College of Cornell UniversityEliana Weinstein, BS, Study director, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018782
- Sponsor's protocol ID
- 1608017472
- Status last verified
- Jul 2021
- First submitted
- 17 Dec 2016
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers
Publications
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.
PubMed 32502219
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation of a Novel Pain-screening Tool in the Diagnoses of Pain Symptoms and Syndromes in Refugee Survivors of Torture
- ClinicalTrials.gov ID
- NCT03018782
- Acronym / sponsor ID
- 1608017472
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief Pain Inventory Short Form | Other | Other: Brief Pain Inventory Short FormCompletes the Brief Pain Inventory Short Form |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women from any country over the age of 18
- refugees receiving services from the Weill Cornell Center for Human Rights
Key exclusion criteria (2 listed)
- Have not experienced torture
- Subjects whose representative does not believe that they are a good candidate for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Pain Inventory Short FormBrief Pain Inventory Short Form | Other | Brief Pain Inventory Short Form |
Primary outcome
Number of participants with chronic pain or pain syndromes as assessed by a non-invasive pain evaluation conducted by a pain physician
Time frame: Day 1
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
1 secondary outcome
Number of participants with chronic pain or pain syndromes as assessed by the Brief Pain Inventory (BPI) Short Form
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Derived from this study: PubMed 32502219Kaur 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunisha Kaur, MD principal investigator
Weill Medical College of Cornell University
Eliana Weinstein, BS study director
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Pain Inventory Short Form in people with Pain, Chronic, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with chronic pain or pain syndromes as assessed by a non-invasive pain evaluation conducted by a pain physician (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03018782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.