Chronic Pain Diagnosis and Treatment in Torture Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Aim 3: The recruitment as measured by the number of participants enrolled.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •≥ 18 years old
- •Survived torture as defined by the World Medical Association
- •Consented to being contacted by our research team
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Pain Evaluation and BPISF (Other)
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.
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.
干预措施: Surveys, a fingerstick blood sample, EMAs, and a digital wearable device (Other)
结局指标
主要结局
Aim 3: The recruitment as measured by the number of participants enrolled.
时间窗: 1.5 years
The investigators aim to recruit 20 participants.
Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by pain specialist evaluation.
时间窗: 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".
Aim 2: Themes emerging across qualitative interview transcripts.
时间窗: Day 1 (One-time Research Appointment)
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.
Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by the United Nations Istanbul Protocol (UNIP).
时间窗: Day 1 (One-time Research Appointment)
The UNIP results in a binary "yes" or "no" clinical pain diagnosis by the evaluator.
Aim 3: The retention as measured by the number of participants who complete the follow-up appointment 6 months after their baseline appointment.
时间窗: 6 months
Aim 3: The adherence as measured by the number of participants who wear their Fitbit for 1 or more days.
时间窗: 6 months
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).
时间窗: 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 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.
Aim 3: The adherence as measured by the number of participants who answer 1 or more Ecological Momentary Assessment (EMA) questions.
时间窗: 6 months
Participants are sent EMA questions each week to assess their levels of stress and pain, as well as their cardiovascular symptoms.
次要结局
- 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)
- Aim 3: Number of participants with positive scores on the Refugee Post Migration Stress Scale (RPMS).(6-month appointment)
- Aim 3: The mean score for pain interference as assessed by the Brief Pain Inventory Short Form (BPISF).(6-month follow-up appointment)
- Aim 3: Number of participants with positive scores on the Stress of Immigration - Short Form (SOIS-SF).(6-month follow-up appointment)
- Aim 3: Number of participants with positive scores on the World Health Organization Rose Angina Questionnaire (WHOAQ).(6-month follow-up appointment)
- Aim 3: Number of participants with positive scores on the Atherosclerotic Cardiovascular Disease Pooled Cohort Equation (ASCVD PCE).(6-month follow-up appointment)
- Aim 3: The mean score for pain severity as assessed by the Brief Pain Inventory Short Form (BPISF).(6-month follow-up appointment)
- Aim 3: Number of participants with positive scores on the Refugee Health Screener-15 (RHS-15).(6-month follow-up appointment)
- Aim 3: Number of participants with positive scores on the Refugee Trauma History Checklist (RTHC).(Baseline appointment)
- Aim 3: Number of participants who have pain, stress, or CVD symptoms, as signalled by continuous biometric data.(6 months)
- Aim 3: Number of participants for whom "yes" is indicated for pain as assessed by the Brief Pain Inventory Short Form (BPISF).(6-month follow-up appointment)
- Aim 3: Number of participants with positive scores on the Questionnaire Verifying Stroke Free Status (QVSFS).(6-month follow-up appointment)
- Aim 3: Number of participants who have self-reports of Cardiovascular disease (CVD) symptoms and events.(6-month follow-up appointment)
- Aim 3: The mean score on the Stress of Immigration - Short Form (SOIS-SF).(6-month follow-up appointment)
- Aim 3: Number of participants for whom "yes" is indicated for pain as assessed by the Brief Pain Inventory Short Form (BPISF).(Baseline appointment)
- Aim 3: The mean score for pain severity as assessed by the Brief Pain Inventory Short Form (BPISF).(Baseline appointment)
- Aim 3: The mean score on the Stress of Immigration - Short Form (SOIS-SF).(Baseline appointment)
- Aim 3: The mean score for pain interference as assessed by the Brief Pain Inventory Short Form (BPISF).(Baseline appointment)
- Aim 3: Number of participants with positive scores on the Refugee Health Screener-15 (RHS-15).(Baseline appointment)
- Aim 3: Number of participants with positive scores on the Stress of Immigration - Short Form (SOIS-SF).(Baseline appointment)
- Aim 3: Number of participants with positive scores on the Refugee Post Migration Stress Scale (RPMS).(Baseline appointment)
- Aim 3: Number of participants with positive scores on the Atherosclerotic Cardiovascular Disease Pooled Cohort Equation (ASCVD PCE).(Baseline appointment)
- Aim 3: Number of participants with positive scores on the World Health Organization Rose Angina Questionnaire (WHOAQ).(Baseline appointment)
- Aim 3: Number of participants with positive scores on the Questionnaire Verifying Stroke Free Status (QVSFS).(Baseline appointment)
- Aim 3: Number of participants who have self-reports of Cardiovascular disease (CVD) symptoms and events.(Baseline appointment)