NCT06795386Recruiting
Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults
Determining Mechanisms of Pain Reduction in Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults
Source: ClinicalTrials.gov · Last updated 28 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 22 Jan 2025
- Start date
- 9 Oct 2023
- Primary completion date
- Sept 2027
- Lead sponsor
- New York University
- Diseases
- Obesity
- NCT number
- NCT06795386
What you commit to
- Study type: Observational
- Planned participants: 60
- From 9 Oct 2023 to the primary completion date, Sept 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Pain localized to surgical sites at 3 months post-surgery
Other illness
- Have a systemic autoimmune disorder or immunodeficiency
- Have an unstable psychological condition
Other
- Are non-ambulatory or ambulate with an assistive device other than a cane
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Steinhardt Arthur J. Nelson Laboratory Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| New York City Health + Hospitals/Bellevue Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| NYU CTSI Clinical Research Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.