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Pain Evaluation for Chronic Pain

N/A

Recruiting

Led By Gunisha Kaur, MA, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a validated pain screen can improve the ability to detect pain in torture survivors, who are often under-diagnosed.

Who is the study for?

This trial is for adults over 18 who have survived torture, as defined by the World Medical Association, and suffer from chronic pain. Participants must consent to contact by researchers and own a personal smartphone. It excludes non-tortured refugees, pregnant women, or those planning to move within six months.

What is being tested?

The study aims to improve chronic pain diagnosis in torture survivors using validated screens alongside the UN Istanbul Protocol. It also assesses treatment acceptability through interviews and tests a digital pain program's feasibility over six months.

What are the potential side effects?

Since this trial involves surveys, blood samples, EMAs (Ecological Momentary Assessments), and wearable devices rather than medications or invasive procedures, side effects are minimal but may include discomfort from fingersticks or wearing the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by pain specialist evaluation.

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).

Aim 1: Number of participants for whom "yes" is indicated for pain as assessed by the United Nations Istanbul Protocol (UNIP).

+3 more

Secondary study objectives

Aim 3: Number of participants for whom "yes" is indicated for pain as assessed by the Brief Pain Inventory Short Form (BPISF).

Aim 3: Number of participants who have pain, stress, or CVD symptoms, as signalled by continuous biometric data.

Aim 3: Number of participants who have self-reports of Cardiovascular disease (CVD) symptoms and events.

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Aim 3: Enrollment in a digital program assessing stress, pain, and cardiovascular healthExperimental Treatment1 Intervention

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.

Group II: Aim 1: Pain EvaluationExperimental Treatment1 Intervention

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.

Group III: Aim 2: Qualitative InterviewActive Control1 Intervention

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.

0 / 1Eligibility criteria met