Chronic Pain Diagnosis and Treatment in Torture Survivors

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Pain, Chronic; Pain

Treatments: Other: Pain Evaluation and BPISF; Other: Surveys, a fingerstick blood sample, EMAs, and a digital wearable device

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04629963

1K23NS116114-01A1 (U.S. NIH Grant/Contract)

20-10022730

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

(Aim 1)

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

(Aim 2)

Inclusion Criteria:

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

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 3): Inclusion Criteria

• ≥ 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
• Planned move within 6 months

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Aim 1: Pain Evaluation

Experimental group

Description:

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.

Treatment:

Other: Pain Evaluation and BPISF

Aim 2: Qualitative Interview

No Intervention group

Description:

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.

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

Experimental group

Description:

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.

Treatment:

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