|

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

RECRUITINGSponsored by New York University
Actively Recruiting
SponsorNew York University
Started2023-10-09
Est. completion2027-09
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
Locations3 sites

Summary

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
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:

  1. self-reported pain at 3 or more anatomical sites
  2. painful regions on both sides of the body
  3. 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

Conditions4

Bariatric Surgery CandidateChronic Pain, WidespreadObesityWeight Loss

Locations3 sites

NYU Steinhardt Arthur J. Nelson Laboratory
New York, New York, 10010
Ericka N Merriwether, PT, DPT, PhD212-998-9192em3766@nyu.edu
New York City Health + Hospitals/Bellevue Hospital
New York, New York, 10016
Manish Parikh, MD212-562-3917manish.parikh@bellevue.nychhc.org
NYU CTSI Clinical Research Center
New York, New York, 10016
Nurse Manager, RN, MA, CCRC646-501-0637rosario.medina@nyulangone.org

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.