Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06795386

Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults

Led by New York University · Updated on 2025-01-28

60

Participants Needed

3

Research Sites

229 weeks

Total Duration

On this page

Sponsors

N

New York University

Lead Sponsor

N

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Self-identify as Black/African American or Hispanic/Latino ethnicity based on the U.S Census racial categories
  • Eligible candidates for bariatric surgery with BMI ≥40 or BMI ≥35 with comorbidity
  • Meet chronic widespread pain criteria: pain at 3 or more body sites, pain on both sides of the body, and pain intensity at rest ≥3 on Numeric Pain Rating Scale
  • Fluent in English or Spanish
  • Able to give voluntary, written informed consent
  • Able to walk independently or with a cane before enrollment
Not Eligible

You will not qualify if you...

  • Previous history of bariatric surgery
  • Have acute pain lasting less than 6 weeks at 1 month before enrollment
  • Have a systemic autoimmune disorder or immunodeficiency
  • Have an unstable psychological condition
  • Are non-ambulatory or use an assistive device other than a cane
  • Pain localized to surgical sites at 3 months after surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

NYU Steinhardt Arthur J. Nelson Laboratory

New York, New York, United States, 10010

Actively Recruiting

2

New York City Health + Hospitals/Bellevue Hospital

New York, New York, United States, 10016

Actively Recruiting

3

NYU CTSI Clinical Research Center

New York, New York, United States, 10016

Actively Recruiting

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Research Team

E

Ericka N Merriwether, PT, DPT, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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