Chronic Pain Diagnosis and Treatment in Torture Survivors

Pain Clinical Trial

Official title:

Chronic Pain Diagnosis and Treatment in Torture Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04629963
• Other study ID #: 20-10022730
• Secondary ID: 1K23NS116114-01A
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: Weill Medical College of Cornell University
• Contact: Gunisha Kaur, MA, MD
• Phone: (212) 746-2461
• Email: gus2004[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

(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

Related Conditions & MeSH terms

• Chronic Pain
• Pain
• Pain, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Bellevue/New York University Program for Survivors of Torture	New York	New York
United States	Columbia University Human Rights Initiative and Asylum Clinic	New York	New York
United States	Mount Sinai Human Rights Program	New York	New York
United States	Weill Cornell Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by the United Nations Istanbul Protocol (UNIP).	The UNIP results in a binary "yes" or "no" clinical pain diagnosis by the evaluator.	Day 1 (One-time Research Appointment)
Primary	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).	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 participant who experiences interference as mild, moderate, or severe pain will be categorized as "yes" for pain; any participant who experiences pain as mild, moderate, or severe will be categorized as "yes" for pain. A score of 0 will be categorized as "no" for pain on the BPISF.	Day 1 (One-time Research Appointment)
Primary	Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by pain specialist evaluation.	The presence of pain detected by the pain specialist evaluation will be categorized as a binary "yes" or "no".	Day 1 (One-time Research Appointment)
Primary	Aim 2: Themes emerging across qualitative interview transcripts.	A thematic coding scheme will be created following the main points of the interview guide. Reports will be generated for each code and narratives will be analyzed for common themes related to acceptability of pain treatments and the relationship between stress and chronic pain. We will utilize the data gained from this Aim to adapt the design of our proposed evidence-based somatic pain treatment model.	Day 1 (One-time Research Appointment)
Primary	Aim 3: The recruitment as measured by the number of participants enrolled.	The investigators aim to recruit 20 participants.	1.5 years
Primary	Aim 3: The retention as measured by the number of participants who complete the follow-up appointment 6 months after their baseline appointment.		6 months
Primary	Aim 3: The adherence as measured by the number of participants who answer 1 or more Ecological Momentary Assessment (EMA) questions.	Participants are sent EMA questions each week to assess their levels of stress and pain, as well as their cardiovascular symptoms.	6 months
Primary	Aim 3: The adherence as measured by the number of participants who wear their Fitbit for 1 or more days.		6 months
Secondary	Aim 3: Number of participants for whom "yes" is indicated for pain as assessed by the Brief Pain Inventory Short Form (BPISF).	The continuous BPISF will be converted into a binary "yes" or "no" for pain. Any participant who experiences mild, moderate, or severe pain or pain interference will be categorized as "yes" for pain; a score of 0 will be categorized as "no" for pain on the BPISF.	Baseline appointment
Secondary	Aim 3: Number of participants for whom "yes" is indicated for pain as assessed by the Brief Pain Inventory Short Form (BPISF).	The continuous BPISF will be converted into a binary "yes" or "no" for pain. Any participant who experiences mild, moderate, or severe pain or pain interference will be categorized as "yes" for pain; a score of 0 will be categorized as "no" for pain on the BPISF.	6-month follow-up appointment
Secondary	Aim 3: The mean score for pain severity as assessed by the Brief Pain Inventory Short Form (BPISF).	Questions 3-6 on the BPISF assess mean pain severity score; these questions are scored on a scale of 0 to 10, with 0 indicating "no pain" and 10 indicating "pain as bad as you can imagine."	Baseline appointment
Secondary	Aim 3: The mean score for pain severity as assessed by the Brief Pain Inventory Short Form (BPISF).	Questions 3-6 on the BPISF assess mean pain severity score; these questions are scored on a scale of 0 to 10, with 0 indicating "no pain" and 10 indicating "pain as bad as you can imagine."	6-month follow-up appointment
Secondary	Aim 3: The mean score for pain interference as assessed by the Brief Pain Inventory Short Form (BPISF).	Question 9 on the BPISF, comprised of 7 parts, assesses mean pain interference; these questions are scored on a scale of 0 to 10, with 0 indicating "does not interfere" and 10 indicating "completely interferes."	Baseline appointment
Secondary	Aim 3: The mean score for pain interference as assessed by the Brief Pain Inventory Short Form (BPISF).	Question 9 on the BPISF, comprised of 7 parts, assesses mean pain interference; these questions are scored on a scale of 0 to 10, with 0 indicating "does not interfere" and 10 indicating "completely interferes."	6-month follow-up appointment
Secondary	Aim 3: Number of participants with positive scores on the Refugee Health Screener-15 (RHS-15).	Symptoms are scored from 0 to 4. A score of 0 indicates "not at all" and a score of 4 indicates "extremely." The survey also asks participants to rate their distress according to a distress thermometer; the thermometer scale ranges from 0 to 10, with 0 indicating "no distress" and 10 indicating "extreme distress." Screening is defined as positive with a total score greater than or equal to 12 on the first 14 items or a ranking greater than 5 on the distress thermometer.	Baseline appointment
Secondary	Aim 3: Number of participants with positive scores on the Refugee Health Screener-15 (RHS-15).	Symptoms are scored from 0 to 4. A score of 0 indicates "not at all" and a score of 4 indicates "extremely." The survey also asks participants to rate their distress according to a distress thermometer; the thermometer scale ranges from 0 to 10, with 0 indicating "no distress" and 10 indicating "extreme distress." Screening is defined as positive with a total score greater than or equal to 12 on the first 14 items or a ranking greater than 5 on the distress thermometer.	6-month follow-up appointment
Secondary	Aim 3: Number of participants with positive scores on the Refugee Trauma History Checklist (RTHC).	The RTHC is comprised of binary "yes" and "no" questions. The RTHC is considered quantitatively positive if any item is marked as "yes."	Baseline appointment
Secondary	Aim 3: Number of participants with positive scores on the Stress of Immigration - Short Form (SOIS-SF).	The SOIS-SF is considered positive if the participant answered a subscale score of more than 1 for any of the individual items in the survey. The subscale ranges from 1 to 5, with a score of 1 indicating "no stress" and a score of 5 indicating "severe stress."	Baseline appointment
Secondary	Aim 3: Number of participants with positive scores on the Stress of Immigration - Short Form (SOIS-SF).	The SOIS-SF is considered positive if the individual answered a subscale score of more than 1 for any of the individual items in the survey. The subscale ranges from 1 to 5, with a score of 1 indicating "no stress" and a score of 5 indicating "severe stress."	6-month follow-up appointment
Secondary	Aim 3: The mean score on the Stress of Immigration - Short Form (SOIS-SF).	The SOIS-SF subscale ranges from 1 to 5, with a score of 1 indicating "no stress" and a score of 5 indicating "severe stress." The SOIS-SF is scored by averaging the scores of the 5-item survey. The mean of non-missing items results in a score of 1 to 5.	Baseline appointment
Secondary	Aim 3: The mean score on the Stress of Immigration - Short Form (SOIS-SF).	The SOIS-SF subscale ranges from 1 to 5, with a score of 1 indicating "no stress" and a score of 5 indicating "severe stress." The SOIS-SF is scored by averaging the scores of the 5-item survey. The mean of non-missing items results in a score of 1 to 5.	6-month follow-up appointment
Secondary	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.		Baseline appointment
Secondary	Aim 3: Number of participants with positive scores on the Refugee Post Migration Stress Scale (RPMS).	The RPMS is considered positive if the individual answered a subscale score of more than 1 for any of the individual items in the survey. The subscale ranges from 1 to 5, with 1 indicating "never" and 5 indicating "very often." Items marked as a subscale score greater than 1 on the RPMS will be considered sources of stress.	Baseline appointment
Secondary	Aim 3: Number of participants with positive scores on the Refugee Post Migration Stress Scale (RPMS).	The RPMS is considered positive if the individual answered a subscale score of more than 1 for any of the individual items in the survey. The subscale ranges from 1 to 5, with 1 indicating "never" and 5 indicating "very often." Items marked as a subscale score greater than 1 on the RPMS will be considered sources of stress.	6-month appointment
Secondary	Aim 3: Number of participants with positive scores on the Atherosclerotic Cardiovascular Disease Pooled Cohort Equation (ASCVD PCE).	Positive scores are indicated by =7.5% 10-year ASCVD risk (defined as first-occurrence nonfatal and fatal myocardial infarction (MI) and nonfatal and fatal stroke).	Baseline appointment
Secondary	Aim 3: Number of participants with positive scores on the Atherosclerotic Cardiovascular Disease Pooled Cohort Equation (ASCVD PCE).	Positive scores are indicated by =7.5% 10-year ASCVD risk (defined as first-occurrence nonfatal and fatal myocardial infarction (MI) and nonfatal and fatal stroke).	6-month follow-up appointment
Secondary	Aim 3: Number of participants with positive scores on the World Health Organization Rose Angina Questionnaire (WHOAQ).	The WHOAQ is used to determine if a participant has experienced symptoms of a heart attack. The WHOAQ is positive if any symptoms are recorded.	Baseline appointment
Secondary	Aim 3: Number of participants with positive scores on the World Health Organization Rose Angina Questionnaire (WHOAQ).	The WHOAQ is used to determine if a participant has experienced symptoms of a heart attack. The WHOAQ is positive if any symptoms are recorded.	6-month follow-up appointment
Secondary	Aim 3: Number of participants with positive scores on the Questionnaire Verifying Stroke Free Status (QVSFS).	The QVSFS is used to determine if a participant has experienced symptoms of a stroke. The QVSFS is positive if any questions are answered in the affirmative.	Baseline appointment
Secondary	Aim 3: Number of participants with positive scores on the Questionnaire Verifying Stroke Free Status (QVSFS).	The QVSFS is used to determine if a participant has experienced symptoms of a stroke. The QVSFS is positive if any questions are answered in the affirmative.	6-month follow-up appointment
Secondary	Aim 3: Number of participants who have self-reports of Cardiovascular disease (CVD) symptoms and events.	Participants will be asked if they have experienced any of the following symptoms: anxiety, chest pain, depression, dizziness, dyspnea, fatigue.	Baseline appointment
Secondary	Aim 3: Number of participants who have self-reports of Cardiovascular disease (CVD) symptoms and events.	Participants will be asked if they have experienced any of the following symptoms: anxiety, chest pain, depression, dizziness, dyspnea, fatigue.	6-month follow-up appointment
Secondary	Aim 3: Number of participants who have pain, stress, or CVD symptoms, as signalled by continuous biometric data.	Biometric data including continuous heart rate, actigraphy, sleep, and derived physiological parameters (e.g., resting heart rate and estimated energy expenditure) will be collected using the wrist-worn wearable device.	6 months