Clinical trial NCT04629963: Chronic Pain Diagnosis and Treatment in Torture Survivors
Official title: Chronic Pain Diagnosis and Treatment in Torture Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Pain, Chronic
Keywords: asylum
torture
refugee
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2020-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Investigators will enroll participants from human rights centers and compare the diagnostic ability of the United Nations Istanbul Protocol (UNIP) alone to the UNIP plus a validated pain screen (BPISF), both against the gold standard for pain assessment (pain specialist exam). Participants will complete individual interviews during which we will present our somatic pain treatment model and receive feedback on challenges, limitations, and acceptability of the interventions. A feasibility sub-study will be conducted with the primary outcome being recruitment and retention of participants over a 6-month period. Secondary outcomes include analysis of study visit data (i.e. migration stress, pain, cardiovascular) collected at enrollment and again after 6 months. Digital and biometric data will be collected continuously from a study-provided smartphone application and wearable fitness device for up to 6 months.
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by the United Nations Istanbul Protocol (UNIP).
timeFrame: Day 1 (One-time Research Appointment)
measure: Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by the United Nations Istanbul Protocol (UNIP) and the Brief Pain Inventory Short Form (BPISF).
timeFrame: Day 1 (One-time Research Appointment)
measure: Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by pain specialist evaluation.
timeFrame: Day 1 (One-time Research Appointment)
measure: Aim 2: Themes emerging across qualitative interview transcripts.
timeFrame: Day 1 (One-time Research Appointment)
measure: Aim 3: The recruitment as measured by the number of participants enrolled.
timeFrame: 1.5 years
measure: Aim 3: The retention as measured by the number of participants who complete the follow-up appointment 6 months after their baseline appointment.
timeFrame: 6 months
measure: Aim 3: The adherence as measured by the number of participants who answer 1 or more Ecological Momentary Assessment (EMA) questions.
timeFrame: 6 months
measure: Aim 3: The adherence as measured by the number of participants who wear their Fitbit for 1 or more days.
timeFrame: 6 months
Secondary outcomes:
measure: Aim 3: Number of participants for whom "yes" is indicated for pain as assessed by the Brief Pain Inventory Short Form (BPISF).
timeFrame: Baseline appointment
measure: Aim 3: Number of participants for whom "yes" is indicated for pain as assessed by the Brief Pain Inventory Short Form (BPISF).
timeFrame: 6-month follow-up appointment
measure: Aim 3: The mean score for pain severity as assessed by the Brief Pain Inventory Short Form (BPISF).
timeFrame: Baseline appointment
measure: Aim 3: The mean score for pain severity as assessed by the Brief Pain Inventory Short Form (BPISF).
timeFrame: 6-month follow-up appointment
measure: Aim 3: The mean score for pain interference as assessed by the Brief Pain Inventory Short Form (BPISF).
timeFrame: Baseline appointment
measure: Aim 3: The mean score for pain interference as assessed by the Brief Pain Inventory Short Form (BPISF).
timeFrame: 6-month follow-up appointment
measure: Aim 3: Number of participants with positive scores on the Refugee Health Screener-15 (RHS-15).
timeFrame: Baseline appointment
measure: Aim 3: Number of participants with positive scores on the Refugee Health Screener-15 (RHS-15).
timeFrame: 6-month follow-up appointment
measure: Aim 3: Number of participants with positive scores on the Refugee Trauma History Checklist (RTHC).
timeFrame: Baseline appointment
measure: Aim 3: Number of participants with positive scores on the Stress of Immigration - Short Form (SOIS-SF).
timeFrame: Baseline appointment
measure: Aim 3: Number of participants with positive scores on the Stress of Immigration - Short Form (SOIS-SF).
timeFrame: 6-month follow-up appointment
measure: Aim 3: The mean score on the Stress of Immigration - Short Form (SOIS-SF).
timeFrame: Baseline appointment
measure: Aim 3: The mean score on the Stress of Immigration - Short Form (SOIS-SF).
timeFrame: 6-month follow-up appointment
measure: Aim 3: Number of participants who say they would be willing to provide a saliva or hair sample to measure cortisol levels in a hypothetical future study.
timeFrame: Baseline appointment
measure: Aim 3: Number of participants with positive scores on the Refugee Post Migration Stress Scale (RPMS).
timeFrame: Baseline appointment
measure: Aim 3: Number of participants with positive scores on the Refugee Post Migration Stress Scale (RPMS).
timeFrame: 6-month appointment
measure: Aim 3: Number of participants with positive scores on the Atherosclerotic Cardiovascular Disease Pooled Cohort Equation (ASCVD PCE).
timeFrame: Baseline appointment
measure: Aim 3: Number of participants with positive scores on the Atherosclerotic Cardiovascular Disease Pooled Cohort Equation (ASCVD PCE).
timeFrame: 6-month follow-up appointment
measure: Aim 3: Number of participants with positive scores on the World Health Organization Rose Angina Questionnaire (WHOAQ).
timeFrame: Baseline appointment
measure: Aim 3: Number of participants with positive scores on the World Health Organization Rose Angina Questionnaire (WHOAQ).
timeFrame: 6-month follow-up appointment
measure: Aim 3: Number of participants with positive scores on the Questionnaire Verifying Stroke Free Status (QVSFS).
timeFrame: Baseline appointment
measure: Aim 3: Number of participants with positive scores on the Questionnaire Verifying Stroke Free Status (QVSFS).
timeFrame: 6-month follow-up appointment
measure: Aim 3: Number of participants who have self-reports of Cardiovascular disease (CVD) symptoms and events.
timeFrame: Baseline appointment
measure: Aim 3: Number of participants who have self-reports of Cardiovascular disease (CVD) symptoms and events.
timeFrame: 6-month follow-up appointment
measure: Aim 3: Number of participants who have pain, stress, or CVD symptoms, as signalled by continuous biometric data.
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue/New York University Program for Survivors of Torture
state: New York
city: New York
country: United States
facility: Mount Sinai Human Rights Program
state: New York
city: New York
country: United States
facility: Columbia University Human Rights Initiative and Asylum Clinic
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Gunisha Kaur, MA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Claudia Hatef, BS
role: STUDY_DIRECTOR
References: