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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
New York City Health + Hospitals/Bellevue Hospital
RECRUITING
New York
NYU CTSI Clinical Research Center
RECRUITING
New York
NYU Steinhardt Arthur J. Nelson Laboratory
RECRUITING
New York
Contact Information
Primary
Ericka N Merriwether, PT, DPT, PhD
em3766@nyu.edu
2129989192
Time Frame
Start Date: 2023-10-09
Estimated Completion Date: 2028-03
Participants
Target number of participants: 60
Treatments
Racialized adults with chronic widespread pain
Adults who self-identify as non-Hispanic Black and/or Hispanic/Latino by the U.S. Census have elected to undergo bariatric surgery. All study participants will undergo bariatric surgery as part of the standard of care for surgical weight loss and will not be randomized to any other placebo or control interventions for weight loss or pain.
Related Therapeutic Areas
Sponsors
Leads: New York University
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This content was sourced from clinicaltrials.gov