Pain Evaluation for Chronic Pain

Recruiting at 3 trial locations

Overseen By Gunisha Kaur, MA, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Non-tortured refugees, Pregnant women, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores better ways to diagnose and manage chronic pain in torture survivors. It aims to improve pain detection and assess whether a digital program can aid in pain and stress management. Participants will undergo interviews and use wearable devices to track health data over six months. Torture survivors experiencing chronic pain, who also have a personal smartphone, might be a good fit for this trial. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to innovative solutions for managing chronic pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team for more details.

What prior data suggests that this protocol is safe for participants?

Research has shown that the Brief Pain Inventory Short Form (BPISF) safely measures pain. As a questionnaire, it requires no medication or medical procedures. Widely used and translated into many languages, the BPISF has proven reliable and consistent. Being just a survey, it poses no safety concerns or side effects, making it user-friendly. Participants in studies using the BPISF have reported no problems, as it is non-invasive and simply collects information about pain levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to gather comprehensive data on chronic pain, stress, and cardiovascular health using innovative approaches. Unlike standard treatments that often focus solely on symptom management, this trial incorporates continuous monitoring with wearable technology, providing real-time insights into the participants' physiological responses. The use of a smartphone app to evaluate stress and pain offers a modern, accessible way for participants to report symptoms, potentially leading to more personalized treatment strategies. By analyzing diverse factors like mental health and migration stress, researchers hope to uncover new connections and improve chronic pain management.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that the Brief Pain Inventory Short Form (BPISF), which participants in this trial will complete, is a helpful tool for assessing pain. It measures pain severity and its impact on daily activities. Studies have found that BPISF is reliable and accurate, consistently providing correct results. It has been used in many countries and translated into numerous languages, making it accessible to diverse groups. These features suggest BPISF could effectively identify and assess pain levels in torture survivors, aiding in their diagnosis and treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Gunisha Kaur, MA, MD

Principal Investigator

Weill Medical College of Cornell University

Claudia Hatef, BS

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have long-term pain.

Consented to being contacted by our research team

You have experienced torture as defined by the World Medical Association.

Exclusion Criteria

People who are applying for refugee status due to being victims of trafficking, violence, or other forms of harm.

Planned move within 6 months

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pain Evaluation

Participants complete the validated pain questionnaire, the Brief Pain Inventory Short Form (BPISF), and receive a non-invasive physical exam and pain assessment by a pain specialist.

1 day

1 visit (in-person)

Qualitative Interview

Participants complete individual interviews to assess the acceptability of somatic pain treatment.

1 day

1 visit (in-person or virtual)

Digital Program Enrollment

Participants are enrolled in a digital program assessing stress, pain, and cardiovascular health, with continuous data collection over six months.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, mental health status, trauma history, migration stress, and cardiovascular risk factors.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• BPISF

Trial Overview 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.

How Is the Trial Designed?

Group I: Aim 3: Enrollment in a digital program assessing stress, pain, and cardiovascular health Experimental Treatment 1 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 Evaluation Experimental Treatment 1 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 Interview Active Control 1 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.

BPISF is already approved in European Union, United States for the following indications:

Approved in European Union as Lynparza for:

• Breast cancer
• Ovarian cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer
• Endometrial cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

The Amharic version of the Brief Pain Inventory (BPI) has demonstrated strong internal consistency and reliability, with Cronbach's alpha values of 0.89 for pain severity and 0.91 for pain interference, indicating it is a reliable tool for assessing pain in Ethiopian patients with chronic musculoskeletal pain.

The study confirmed the construct validity of the Amharic BPI using a two-factor model, making it suitable for clinical and research applications in similar settings, as it effectively measures both pain severity and interference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the validity of the Amharic Brief Pain Inventory among people with chronic primary musculoskeletal pain in Ethiopia. Abebe, AB., Ayele, TA., Miller, J.[2022]

A new ultra-brief three-item pain measure called the PEG was developed from the Brief Pain Inventory (BPI) and showed strong reliability (alpha = 0.73 to 0.89) and good construct validity in two studies involving 500 primary care patients and 646 veterans.

The PEG effectively assesses chronic pain by measuring average pain intensity and its interference with life and activities, making it a practical tool for improving pain assessment in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. Krebs, EE., Lorenz, KA., Bair, MJ., et al.[2022]

The Brief Pain Inventory (BPI) was developed to improve the measurement and assessment of cancer pain, addressing a major barrier to effective pain management in cancer patients.

The BPI has shown reliability and validity across different cultures and languages, making it a widely adopted tool for clinical assessments and research on pain treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain assessment: global use of the Brief Pain Inventory. Cleeland, CS., Ryan, KM.[2022]

Cancer patients experience greater interference with physical functions due to pain compared to noncancer chronic pain patients, even at the same pain intensity level, highlighting the unique challenges faced by cancer patients (P<0.001).

Noncancer chronic pain patients report higher psychological interference from pain than cancer patients, suggesting that the impact of pain on mental health may differ significantly between these groups (P=0.023).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Brief Pain Inventory: pain's interference with functions is different in cancer pain compared with noncancer chronic pain. Hølen, JC., Lydersen, S., Klepstad, P., et al.[2015]

The Persian version of the Brief Pain Inventory (BPI-P) was developed and validated for assessing chronic pain in Iranian patients, demonstrating good internal consistency and test-retest reliability with a sample of 201 participants.

Factor analysis revealed that the BPI-P effectively measures two key aspects of pain: pain intensity and pain interference with daily life, which together explained 68.4% of the variance in pain assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Persian Version of the Brief Pain Inventory (BPI-P) in Chronic Pain Patients. Majedi, H., Dehghani, SS., Soleyman-Jahi, S., et al.[2022]

Citations

1. mdanderson.org mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/brief-pain-inventory.html

Brief Pain Inventory (BPI) The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The BPI has been translated into dozens of languages, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7191979/

Measurement Properties of the Brief Pain Inventory-Short ... This review protocol describes the steps that will be taken to locate, critically appraise, compare and summarize clinical measurement research on the BPI-SF ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0197457223001052

Validity and reliability of the short form brief pain inventory ... The aim of this study was to evaluate the validity and reliability of the Short Form Brief Pain Inventory (SF-BPI) for community-dwelling Brazilian older ...

4. ascopubs.org ascopubs.org/doi/10.1200/jco.2010.28.15_suppl.6112

Estimating minimally important differences (MID) for the ... Conclusions: An MID estimate of 2 points can be clinically useful for interpreting BPI-SF baseline scores as well as changes in worst pain ...

5. academic.oup.com academic.oup.com/painmedicine/article-abstract/21/12/3263/5904390

Brief Pain Inventory–Short Form: A New Method for Assessing ... In this study, we assess the utility and feasibility of the Brief Pain Inventory–Short Form (BPI-SF) in the ED.

6. npcrc.org npcrc.org/files/news/briefpain_short.pdf

Brief Pain Inventory (Short Form) Please rate your pain by marking the box beside the number that best describes your pain on the average. Page 1 of 2. Copyright 1991 Charles S. Cleeland, PhD.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1090380105000789

Reliability and validity of a modified Brief Pain Inventory ... Results indicate that the modified BPI-sf, much like the original scale, was internally reliable, consistent over time, and had good construct, as well as ...

8. mdanderson.org mdanderson.org/documents/Departments-and-Divisions/Symptom-Research/BPI_UserGuide.pdf

The brief pain inventory user guide This version of the BPI retained the front and back body diagrams, the four pain severity items and seven pain interference items rated on 0–10 scales, and the.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16051509/

Reliability and validity of a modified Brief Pain Inventory ... Results indicate that the modified BPI-sf, much like the original scale, was internally reliable, consistent over time, and had good construct, as well as ...