Chronic Pain Diagnosis and Treatment in Torture Survivors

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 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

Locations
United States
New York
Bellevue/New York University Program for Survivors of Torture
ACTIVE_NOT_RECRUITING
New York
Columbia University Human Rights Initiative and Asylum Clinic
NOT_YET_RECRUITING
New York
Mount Sinai Human Rights Program
ACTIVE_NOT_RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
Contact Information
Primary
Gunisha Kaur, MA, MD
gus2004@med.cornell.edu
(212) 746-2461
Backup
Michele Steinkamp, RN
mls9004@med.cornell.edu
2127462953
Time Frame
Start Date: 2021-01-14
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 100
Treatments
Experimental: 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.
No_intervention: 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.
Experimental: 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.
Authors
Sarah Moore, Elizabeth Singer
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University
Collaborators: National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov