Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults
Recruiting · NCT06795386 · Observational (researchers observe without assigning treatment) · Lead sponsor: New York University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. 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 take part
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 it is running
3 locations listed across 1 US state.
- NYU Steinhardt Arthur J. Nelson Laboratory - New York, New York, United States
- New York City Health + Hospitals/Bellevue Hospital - New York, New York, United States
- NYU CTSI Clinical Research Center - New York, New York, United States