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

Trial Summary

What is the purpose of this trial?

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.

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.

Is the drug BPISF (also known as Lynparza) a promising treatment for chronic pain?

The information provided does not directly evaluate BPISF (Lynparza) as a treatment for chronic pain. The articles focus on the Brief Pain Inventory (BPI), a tool for assessing pain, rather than the effectiveness of BPISF. Therefore, we cannot determine if BPISF is promising for chronic pain based on this information. ^{1 2 3 4 5}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Validation of the Persian Version of the Brief Pain Inventory (BPI-P) in Chronic Pain Patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Evaluating the validity of the Amharic Brief Pain Inventory among people with chronic primary musculoskeletal pain in Ethiopia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. [2022]

4. Singapore pubmed.ncbi.nlm.nih.gov

Pain assessment: global use of the Brief Pain Inventory. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Brief Pain Inventory: pain's interference with functions is different in cancer pain compared with noncancer chronic pain. [2015]