NCT06795386 · New York University
Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults
What this study is about
The goal of this observational study is to learn if surgical weight loss can improve chronic widespread pain in people living with higher BMI who self-identify as Hispanic/Latino ethnicity or non-Hispanic Black based on the United States census racial categories. The main questions the study aims to answer are: 1.
View original scientific description
The goal of this observational study is to learn if surgical weight loss can improve chronic widespread pain in people living with higher BMI who self-identify as Hispanic/Latino ethnicity or non-Hispanic Black based on the United States census racial categories. The main questions the study aims to answer are: 1. Do pain at rest (primary outcome) and movement-evoked pain (secondary outcome) improve after bariatric surgery? 2. Do pain processing and joint function change after bariatric surgery? 3. Are pain processing and joint function associated with clinically significant pain change after surgical weight loss? Researchers will compare pain and function before and 6 months after bariatric surgery in a single cohort.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Self-identify as Black/African American or Hispanic/Latino ethnicity based on the U.S Census racial categories
- Eligible candidates for bariatric surgery (BMI greater than or equal to 40 or BMI greater than or equal to 35 with comorbidity
- Meets criteria for chronic widespread pain (CWP) based on the following:
- self-reported pain at 3 or more anatomical sites
- painful regions on both sides of the body
- self-reported pain intensity at rest of 3 out of 10 or higher using the Numeric Pain Rating Scale (NPRS) or equivalent
- Conversational language fluency in English or Spanish
- Able to give voluntary, written informed consent to participate
- Able to walk independently or with a cane prior to study enrollment
Exclusion criteria
- Prospective participants with a previous history of bariatric surgery
- Have acute pain (pain for less than 6 weeks) at 1 month prior to study enrollment
- Have a systemic autoimmune disorder or immunodeficiency
- Have an unstable psychological condition
- Are non-ambulatory or ambulate with an assistive device other than a cane
- Pain localized to surgical sites at 3 months post-surgery
Where
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 28, 2025 · Source of record for eligibility and locations