Chronic Pain Diagnosis and Treatment in Torture Survivors

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04629963
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
• Enrollment: 100
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 45.5
• Patients Per Site: 25
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The goal 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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Pain, Chronic	Other: Pain Evaluation and BPISF	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Investigators will enroll subjects from four human rights centers in New York City and compare the diagnostic ability of the United Nations Istanbul Protocol (UNIP) alone to the UNIP plus a validated, self-administered pain screen (BPISF), both against the gold standard for pain assessment (pain specialist exam). With a sample size of 100, a 95% confidence interval for the sensitivity of the UNIP + BPISF can be constructed within ± 6.4% of the observed sensitivity. While the investigators' pilot data demonstrate a significant difference in pain diagnosis by the UNIP versus the UNIP + BPISF, data-driven, definitive evidence is needed to change the current medical assessment guidelines of torture survivors.Investigators will enroll subjects from four human rights centers in New York City and compare the diagnostic ability of the United Nations Istanbul Protocol (UNIP) alone to the UNIP plus a validated, self-administered pain screen (BPISF), both against the gold standard for pain assessment (pain specialist exam). With a sample size of 100, a 95% confidence interval for the sensitivity of the UNIP + BPISF can be constructed within ± 6.4% of the observed sensitivity. While the investigators' pilot data demonstrate a significant difference in pain diagnosis by the UNIP versus the UNIP + BPISF, data-driven, definitive evidence is needed to change the current medical assessment guidelines of torture survivors.
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Chronic Pain Diagnosis and Treatment in Torture Survivors
• Actual Study Start Date: Jan 14, 2021
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pain Evaluation Subjects receive the United Nations Istanbul Protocol (UNIP) evaluation. Subjects will complete the validated, self-administered pain questionnaire, the Brief Pain Inventory Short Form (BPISF). Subjects will receive a non-invasive physical exam and pain assessment by a pain specialist.	Other: Pain Evaluation and BPISF; Current diagnostic approaches guide evaluators to use the United Nations Istanbul Protocol (UNIP) for the assessment of torture survivors. The proposed investigation offers a novel diagnostic paradigm by which patients are evaluated by the UNIP and a validated pain screen (Brief Pain Inventory Short Form).

Outcome Measures

Primary Outcome Measures

1. Number of Subjects who Indicate "YES" for Pain as Assessed by the United Nations Istanbul Protocol [Day 1 (One-time Research Appointment)]

   The UNIP results in a binary "yes" or "no" clinical pain diagnosis by the evaluator.

2. Number of Subjects who Indicate "YES" for Pain as Assessed by the United Nations Istanbul Protocol (UNIP) and Brief Pain Inventory Short Form (BPISF) [Day 1 (One-time Research Appointment)]

   As the UNIP results in a binary "yes" or "no" clinical pain diagnosis by the evaluator, the continuous BPISF will be converted into a binary "yes" or "no" for pain. Any subject who experiences mild (score 1-4), moderate (score 5-6), or severe (score 7-10) pain will be categorized as "yes" for pain; a score of 0 will be categorized as "no" for pain on the BPISF.

3. Number of Subjects who Indicate "YES" for Pain as Assessed by Pain Specialist Evaluation [Day 1 (One-time Research Appointment)]

   The presence of pain detected by the pain specialist evaluation will be categorized as a binary "yes" or "no".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ≥ 18 years old

• Survived torture as defined by the World Medical Association

• Consented to being contacted by our research team

Exclusion Criteria:

• Non-tortured refugees seeking asylum through T visas (trafficking), U visas (victims of violence in the US), Violence Against Women Act (VAMA), and Special Immigrant Juveniles (SIJ)

• Pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bellevue/New York University Program for Survivors of Torture	New York	New York	United States	10016
2	Mount Sinai Human Rights Program	New York	New York	United States	10029
3	Columbia University Human Rights Initiative and Asylum Clinic	New York	New York	United States	10032
4	Weill Cornell Medicine	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University
• National Institutes of Health (NIH)
• National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• Principal Investigator: Gunisha Kaur, MA, MD, Weill Medical College of Cornell University
• Study Director: Catherine Gbekie, BS, Weill Medical College of Cornell University
• Study Director: Eliana Weinstein, BS, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT04629963
• Other Study ID Numbers: 20-10022730; 1K23NS116114-01A1
• First Posted: Nov 16, 2020
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Weill Medical College of Cornell University: asylum; torture; refugee
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Mar 25, 2022