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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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).

+5 more

Secondary outcome measures

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.

+11 more

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

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Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

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National Institutes of Health (NIH)NIH

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National Institute of Neurological Disorders and Stroke (NINDS)NIH

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Media Library

BPISF Clinical Trial Eligibility Overview. Trial Name: NCT04629963 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this clinical experiment?

"Correct. Analysis on clinicaltrials.gov affirms that this research is currently in need of participants, having been first posted on 14th January 2021 and last updated 24th March 2022. A total of 100 subjects are sought between 4 distinct sites."

Answered by AI

Are there any current openings for participants in this clinical experiment?

"Affirmative. Per the information accessible on clinicaltrials.gov, this medical study is presently enlisting participants and has been doing so since January 14th 2021. This trial requires 100 patients to be recruited from 4 separate research facilities in order for it to proceed as planned."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chronic Pain Diagnosis and Treatment in Torture Survivors

2021. "Chronic Pain Diagnosis and Treatment in Torture Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04629963.

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