Pain Evaluation for Chronic Pain

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Gunisha Kaur, MA, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Non-tortured refugees, Pregnant women, others

No Placebo Group

Approved in 2 Jurisdictions

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}

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

Trial 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 (Behavioural Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Columbia University Human Rights Initiative and Asylum Clinic New York, NY

Weill Cornell Medicine New York, NY

Mount Sinai Human Rights Program New York, NY

Bellevue/New York University Program for Survivors of Torture New York, NY

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University Lead Sponsor

National Institutes of Health (NIH) Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) Collaborator

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] Chronic pain needs to be evaluated with a standard instrument. The Brief Pain Inventory (BPI) is a pain assessment tool that has been validated in many languages.

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] The Brief Pain Inventory (BPI) is a multidimensional pain assessment tool used to evaluate pain severity and pain interference. The BPI has been translated and validity estimated across multiple languages and patient populations for clinical and research settings. This study aimed to assess the reliability and validity of Amharic BPI test scores among patients with chronic primary musculoskeletal pain living in Ethiopia.

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] Inadequate pain assessment is a barrier to appropriate pain management, but single-item "pain screening" provides limited information about chronic pain. Multidimensional pain measures such as the Brief Pain Inventory (BPI) are widely used in pain specialty and research settings, but are impractical for primary care. A brief and straightforward multidimensional pain measure could potentially improve initial assessment and follow-up of chronic pain in primary care.

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

Pain assessment: global use of the Brief Pain Inventory. [2022] Poorly controlled cancer pain is a significant public health problem throughout the world. There are many barriers that lead to undertreatment of cancer pain. One important barrier is inadequate measurement and assessment of pain. To address this problem, the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care has developed the Brief Pain Inventory (BPI), a pain assessment tool for use with cancer patients. The BPI measures both the intensity of pain (sensory dimension) and interference of pain in the patient's life (reactive dimension). It also queries the patient about pain relief, pain quality, and patient perception of the cause of pain. This paper describes the development of the Brief Pain Inventory and the various applications to which the BPI is suited. The BPI is a powerful tool and, having demonstrated both reliability and validity across cultures and languages, is being adopted in many countries for clinical pain assessment, epidemiological studies, and in studies of the effectiveness of pain treatment.

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] The Brief Pain Inventory (BPI) is a highly recommended and frequently used multidimensional pain assessment tool. The BPI includes 2 dimensions: pain intensity and pain's interference with functions. Our aims were to explore how patients respond to pain interference items by comparing responses from patients who had cancer with patients who had noncancer chronic pain (NCCP), and to explore how different levels of health-related quality of life affect upon pain's interference with functions.