RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-09
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06795386

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self-identify as Black/African American or Hispanic/Latino ethnicity based on the U.S Census racial categories
  2. * Eligible candidates for bariatric surgery (BMI greater than or equal to 40 or BMI greater than or equal to 35 with comorbidity
  3. * Meets criteria for chronic widespread pain (CWP) based on the following:
  4. 1. self-reported pain at 3 or more anatomical sites
  5. 2. painful regions on both sides of the body
  6. 3. self-reported pain intensity at rest of 3 out of 10 or higher using the Numeric Pain Rating Scale (NPRS) or equivalent
  7. * Conversational language fluency in English or Spanish
  8. * Able to give voluntary, written informed consent to participate
  9. * Able to walk independently or with a cane prior to study enrollment
  1. * Prospective participants with a previous history of bariatric surgery
  2. * Have acute pain (pain for less than 6 weeks) at 1 month prior to study enrollment
  3. * Have a systemic autoimmune disorder or immunodeficiency
  4. * Have an unstable psychological condition
  5. * Are non-ambulatory or ambulate with an assistive device other than a cane
  6. * Pain localized to surgical sites at 3 months post-surgery

Contacts and Locations

Study Contact

Ericka N Merriwether, PT, DPT, PhD
CONTACT
2129989192
em3766@nyu.edu

Study Locations (Sites)

NYU Steinhardt Arthur J. Nelson Laboratory
New York, New York, 10010
United States
New York City Health + Hospitals/Bellevue Hospital
New York, New York, 10016
United States
NYU CTSI Clinical Research Center
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: New York University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-09
Study Completion Date2028-03

Study Record Updates

Study Start Date2023-10-09
Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

  • chronic pain, adult obesity, pain equity, rehabilitation

Additional Relevant MeSH Terms

  • Chronic Pain, Widespread
  • Obesity
  • Bariatric Surgery Candidate