Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNew York University
About this trial
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.
Eligibility criteria
Qualifiers
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
self-reported pain at 3 or more anatomical sites
painful regions on both sides of the body
Disqualifiers
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
Trial design
Treatments tested in this trial
- Bariatric Surgery
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
New York University
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov