Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04629963
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2020-11-11
Brief Title:
Chronic Pain Diagnosis and Treatment in Torture Survivors
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Chronic Pain Diagnosis and Treatment in Torture Survivors
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal Aim 1 of this investigation is to characterize the diagnosis of chronic pain in torture survivors The investigators hypothesize that using a validated pain screen to supplement the existing United Nations Istanbul Protocol can improve the ability to detect pain from 15 to 90 in this study population Investigators will test this hypothesis by conducting a prospective blind comparison to gold standard study The goal of Aim 2 is to evaluate the acceptability of somatic pain treatment using qualitative interviews of torture survivors The goal of Aim 3 is to assess the feasibility of recruiting and retaining participants in a digital pain program over six months
Detailed Description:
The objective of this application is to improve the diagnosis and treatment of chronic pain in torture survivors The central hypothesis based on strong preliminary data from 25 subjects from the Weill Cornell Center for Human Rights is that the novel application in torture survivors of a validated pain screen the Brief Pain Inventory Short Form BPISF can supplement the United Nations Istanbul Protocol UNIP and improve its sensitivity for pain from 15 to 90 as compared to the gold standard a pain specialist The rationale for the investigation is to improve the diagnosis of pain in torture survivors leading to targeted treatment
The objectives of this study are to improve the diagnosis of pain in torture survivors with the novel utilization in this population of a pain screen The findings of this study also have implications for other populations that experience complex trauma such as veterans prisoners of war and sexual violence survivors
The primary objective of the qualitative interview portion is to gain an understanding of how participants perceive react to and might utilize somatic pain treatment We aim to qualitatively assess the challenges and acceptability of a proposed evidence-based somatic pain treatment model novel in its implementation in torture survivors physical therapy andor non-opioid analgesics andor trigger point injections We will use the Gelberg and Andersen Behavioral Model of Health Care Utilization for Vulnerable Populations as a conceptual framework to conduct qualitative interviews with 30 participants purposively sampled from Study Aim 1 Data with regard to acceptability and practicality from interviews will be used to adapt our proposed evidence-based somatic pain treatment for torture survivors
The primary objective of Aim 3 is to answer critical questions on the feasibility of a subsequent clinical trial to treat somatic pain in torture survivors As a secondary objective we will analyze the prevalence of migration stress pain and cardiovascular disease and their relationship over time in refugee torture survivors The primary objective of this sub-study is the recruitment retention and adherence of participants to the digital program over a six-month period The secondary objectives of this sub-study are the assessment of pain mental health status trauma history migration stress and cardiovascular risk factors and diseases
The objectives of this study are to improve the diagnosis of pain in torture survivors with the novel utilization in this population of a pain screen The findings of this study also have implications for other populations that experience complex trauma such as veterans prisoners of war and sexual violence survivors
The primary objective of the qualitative interview portion is to gain an understanding of how participants perceive react to and might utilize somatic pain treatment We aim to qualitatively assess the challenges and acceptability of a proposed evidence-based somatic pain treatment model novel in its implementation in torture survivors physical therapy andor non-opioid analgesics andor trigger point injections We will use the Gelberg and Andersen Behavioral Model of Health Care Utilization for Vulnerable Populations as a conceptual framework to conduct qualitative interviews with 30 participants purposively sampled from Study Aim 1 Data with regard to acceptability and practicality from interviews will be used to adapt our proposed evidence-based somatic pain treatment for torture survivors
The primary objective of Aim 3 is to answer critical questions on the feasibility of a subsequent clinical trial to treat somatic pain in torture survivors As a secondary objective we will analyze the prevalence of migration stress pain and cardiovascular disease and their relationship over time in refugee torture survivors The primary objective of this sub-study is the recruitment retention and adherence of participants to the digital program over a six-month period The secondary objectives of this sub-study are the assessment of pain mental health status trauma history migration stress and cardiovascular risk factors and diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23NS116114-01A1 | NIH | None | httpsreporternihgovquickSearch1K23NS116114-01A1 |