Chronic Pain Diagnosis and Treatment in Torture Survivors

NCT ID: NCT04629963

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-14
• Study Completion Date: 2026-01-31

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 and/or non-opioid analgesics and/or 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.

Conditions

Pain; Pain, Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Aim 1: Pain Evaluation

Participants will complete the validated pain questionnaire, the Brief Pain Inventory Short Form (BPISF). Participants will receive a non-invasive physical exam and pain assessment by a pain specialist.

Group Type: EXPERIMENTAL

Pain Evaluation and BPISF

Intervention Type: OTHER

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 participants are evaluated by the UNIP and a validated pain screen (Brief Pain Inventory Short Form).

Aim 2: Qualitative Interview

Participants will complete individual interviews moderated by the research staff. Interviews will be based on the guide but will be minimally structured to facilitate exploration of novel topics as raised by participants and to ensure information-rich data on topics of interest. Individual interviews will be \~30-45 minutes in length, conducted in the subject's primary language with the use of an interpreter as appropriate. All interviews will be audio-recorded with participants' permission, transcribed, and translated into English for analysis.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Aim 3: Enrollment in a digital program assessing stress, pain, and cardiovascular health

Continuous cardiovascular, stress, and pain data collection will occur for 6 months after enrollment. Biometric data including continuous heart rate, actigraphy, sleep, and derived physiological parameters will be collected using the wearable device. Pain and stress evaluations will be administered via a smartphone app as a survey of stress, pain, or cardiovascular symptoms.

Participants will complete surveys assessing chronic pain, mental health, trauma history, migration stress, and cardiovascular risk factors and disease Total cholesterol, HDL, LDL, triglycerides, and glucose will be measured using a lipid analyzer with a fingerstick blood sample. Height, weight, and blood pressure will also be measured.

Group Type: EXPERIMENTAL

Surveys, a fingerstick blood sample, EMAs, and a digital wearable device

Intervention Type: OTHER

The following surveys: BPI-SF, RHS-15, RTHC, SOIS-SF, RPMS, WHOAQ, QVSFS, a fingerstick blood sample, EMAs, and a digital wearable device

Interventions

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 participants are evaluated by the UNIP and a validated pain screen (Brief Pain Inventory Short Form).

Intervention Type: OTHER

Surveys, a fingerstick blood sample, EMAs, and a digital wearable device

The following surveys: BPI-SF, RHS-15, RTHC, SOIS-SF, RPMS, WHOAQ, QVSFS, a fingerstick blood sample, EMAs, and a digital wearable device

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years old
• Survived torture as defined by the World Medical Association
• Consented to being contacted by our research team

• ≥ 18 years old
• Survived torture as defined by the World Medical Association
• Chronic pain as per Aim 1 findings

• ≥ 18 years old
• Survived torture as defined by the World Medical Association
• Chronic pain as per Aim 1 findings
• Personal smartphone

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

(Aim 2)

• 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

• 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
• Planned move within 6 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gunisha Kaur, MA, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Claudia Hatef, BS

Role: STUDY_DIRECTOR

Weill Medical College of Cornell University

Locations

Bellevue/New York University Program for Survivors of Torture

New York, New York, United States

Site Status: ACTIVE_NOT_RECRUITING

Mount Sinai Human Rights Program

New York, New York, United States

Site Status: ACTIVE_NOT_RECRUITING

Columbia University Human Rights Initiative and Asylum Clinic

New York, New York, United States

Site Status: NOT_YET_RECRUITING

Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gunisha Kaur, MA, MD

Role: CONTACT

gus2004@med.cornell.edu

(212) 746-2461

Michele Steinkamp, RN

Role: CONTACT

mls9004@med.cornell.edu

2127462953

Facility Contacts

Michael Devlin, MD

Role: primary

mjd5@cumc.columbia.edu

(212) 305-6001

Gunisha Kaur, BA, MD

Role: primary

gus2004@med.cornell.edu

(212) 746-2461

Michele Steinkamp, RN

Role: backup

mls9004@med.cornell.edu

2127462953

Other Identifiers

1K23NS116114-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-10022730

Identifier Type: -

Identifier Source: org_study_id